Regional variations in childbirth interventions and their correlations with adverse outcomes, birthplace and care provider: A nationwide explorative study.

BACKGROUND: Variations in childbirth interventions may indicate inappropriate use. Most variation studies are limited by the lack of adjustments for maternal characteristics and do not investigate variations in adverse outcomes. This study aims to explore regional variations in the Netherlands and their correlations with referral rates, birthplace, interventions, and adverse outcomes, adjusted for maternal characteristics.
METHODS: In this nationwide retrospective cohort study, using a national data register, intervention rates were analysed between twelve regions among single childbirths after 37 weeks' gestation in 2010-2013 (n = 614,730). These were adjusted for maternal characteristics using multivariable logistic regression. Primary outcomes were intrapartum referral, birthplace, and interventions used in midwife- and obstetrician-led care. Correlations both between primary outcomes and between adverse outcomes were calculated with Spearman's rank correlations.
FINDINGS: Intrapartum referral rates varied between 55-68% (nulliparous) and 20-32% (multiparous women), with a negative correlation with receiving midwife-led care at the onset of labour in two-thirds of the regions. Regions with higher referral rates had higher rates of severe postpartum haemorrhages. Rates of home birth varied between 6-16% (nulliparous) and 16-31% (multiparous), and was negatively correlated with episiotomy and postpartum oxytocin rates. Among midwife-led births, episiotomy rates varied between 14-42% (nulliparous) and 3-13% (multiparous) and in obstetrician-led births from 46-67% and 14-28% respectively. Rates of postpartum oxytocin varied between 59-88% (nulliparous) and 50-85% (multiparous) and artificial rupture of membranes between 43-52% and 54-61% respectively. A north-south gradient was visible with regard to birthplace, episiotomy, and oxytocin.
CONCLUSIONS: Our study suggests that attitudes towards interventions vary, independent of maternal characteristics. Care providers and policy makers need to be aware of reducing unwarranted variation in birthplace, episiotomy and the postpartum use of oxytocin. Further research is needed to identify explanations and explore ways to reduce unwarranted intervention rates.

Introduction

Rates of interventions during childbirth have been studied worldwide and large variations between countries have been reported [1]. Interventions during childbirth can be crucial in order to prevent neonatal and maternal morbidity and mortality [2] and, therefore, underuse of healthcare services can be an important cause of preventable morbidity and mortality. On the other hand, use without a medical indication may cause avoidable harm, given the risk of adverse effects related to interventions [3-5].

Worldwide, rates of most interventions and referrals during childbirth have increased [1, 6, 7], episiotomy being the exception [1, 8]. The rate of home births varies worldwide and is low in most high-income countries. For instance, in 2017, the rate of home births was 1% in the USA [9], 0.3% in Australia [10], and 2% in England and Wales [11]. The rate of referrals depends on the maternity care system in a country. Alliman et al. (2016) showed a range of intrapartum referral rates from birth centres to hospitals of between 12% and 37% [12], and Blix et al. (2014) a referral rate range from home to hospital of between 10% and 32% [13]. Episiotomy rates vary largely, from 5% in Denmark, to 75% in Cyprus [14].

In the Netherlands, a variation in intrapartum referral rates among midwifery practices has been shown of between 10% and 64% [15]. Since the late twentieth century, referrals during pregnancy and labour have increased continuously. Where in 1999 more than 60% of women received midwife-led care at the onset of labour, this number has decreased to 51% in 2015 [16, 17]. The rate of home births has historically been high in the Netherlands. However, the rate of home births declined from 23% in 2000 to 13% in 2015 [16, 17]. Episiotomy rates declined from 23% in 2005 to 13% in 2015 in the Netherlands.

Variations in the use of interventions between countries may be explained by differences in maternal and perinatal characteristics and perinatal healthcare systems [18]. For example, parity, maternal age, ethnicity, and birthweight are associated with the use of episiotomy [19]. However, since these factors are likely to be more similar within a specific country, less variation may be expected within a country than between countries [20]. If variations persist after adjustment for maternal characteristics, then this may indicate that variations are unwarranted and it may indicate inappropriate use [20, 21]. While on one hand characteristics can be associated with interventions, on the other hand interventions can be associated with improved or worsened neonatal and maternal outcomes [2-5]. Therefore, intervention rates should be investigated in view of adverse outcomes. Similar neonatal and maternal outcomes between regions together with variations in interventions, is another indicator of unwarranted variation [20, 21].

A first step in addressing possible inappropriate use of interventions is to examine regional variations of intrapartum interventions within a country [20]. Regional variation would not be expected in a relatively small country such as the Netherlands without regional differences in the maternity healthcare system. In the Dutch maternity care system, low-risk women start antenatal care in midwife-led primary care. Midwives refer women to obstetrician-led care when risks of adverse outcomes increase or complications arise. Interventions such as episiotomy, artificial rupture of membranes (AROM), and postpartum administration of oxytocin are used in both midwife-led and obstetrician-led care settings [22]. Box 1 citesthe description of the maternity care system in the Netherlands from our previous publication on regional variations in the Netherlands [23].

Box 1. The maternity care system in the Netherlands [23]

In the Netherlands, there are no regional differences in the maternity healthcare system. Low-risk women start antenatal care in midwife-led primary care. These women are cared for by independent midwives who attend home births, low-risk hospital births, and births in alongside and free-standing birth centres. The Dutch Birth Centre Study showed that health outcomes, experiences, and costs for low-risk women are similar for planned birth in a birth centre and planned birth in a hospital, both supervised by a primary care midwife [24, 25]. Midwives refer women to obstetrician-led care when risks of adverse outcomes increase or complications arise. Criteria for referral from midwife-led to obstetrician-led care have been laid out in the obstetric indication list of 2003. Interventions in childbirth such as induction and augmentation of labour, pain medication, instrumental birth, and CS, are only available in an obstetrician-led care setting [22, 26]. These intrapartum interventions may be used for women in midwife-led care at the onset of labour after referral to obstetrician-led care. Interventions such as episiotomy, artificial rupture of membranes (AROM), and postpartum administration of oxytocin are used in both midwife-led and obstetrician-led care settings [22]. The Steering Committee ‘Pregnancy and birth’ recommended in 2009 more integration in maternity care between midwife-led and obstetrician-led care, which led to several regional initiatives to change the organisation of care, but there was not one uniform, national model [27].

The decreased rate of midwife-led births in the Netherlands corresponded with an increased use of interventions on the national level [15, 28]. A previous article described regional variations in rates of induction and augmentation of labour, pain medication, caesarean section, and involvement of paediatrician in the first 24 h after birth [23]. Little information is available as to how regional variations in rates of referral, place of birth, and interventions during childbirth, relate to each other, nor how they might relate to adverse neonatal and maternal outcomes. Knowledge on these correlation will give insight into underlying processes of variations in childbirth interventions, place of birth, and referral, and will help care providers and policy makers to know which variation is large and likely unwarranted and should therefore be the focus of changes in practices and policies with the ultimate aim to improve the quality of maternity care. This article focuses on rates of referral, place of birth, and interventions that are used in both primary midwife-led, and secondary obstetrician-led care. The first aim of this study was to explore which regional variations in intrapartum rates of referral, place of birth, and use of intrapartum interventions, exist for women who gave birth in the Netherlands between 2010 and 2013. Secondly, we aimed to investigate how these variations are correlated to each other. Thirdly, we examined the association between variations, and adverse neonatal and maternal outcomes, adjusted for maternal characteristics.

Methods

Data collection

The methods of this explorative study have been described previously in more detail [23]. For this nationwide study, we used data on single births after 37 weeks of gestation. We focused on single births because multiple pregnancies are associated with much higher risks of adverse outcomes and therefore medical interventions are often justified. These data originated from the national register, “Perined”, covering the years 2010 up to 2013 and including 98% of all births in the Netherlands after 24 weeks of gestation [29]. Patient records were excluded when data were missing on: postal codes or parity; or when data were missing from the midwifery database of women that received both midwife- and obstetrician-led care. The pitfalls in the use of data based on the national register have been described in a recently published article [30].

Selection of variables

We used the twelve Dutch administrative provinces as regions. A record of a birth was allocated to a region on the basis of the mother’s residential postal code. All women, in all regions, have access to all types of birth settings and therefore, these regions were comparable.

Care processes

The following primary outcome variables concerning maternity care processes were examined: the number of women receiving midwife-led care at the onset of their pregnancy, at the onset of labour, and at the time of birth; intrapartum referral to obstetrician-led care, and the planned, and actual place of birth (home, hospital and birth centre midwife-led, hospital obstetrician-led). The onset of labour was defined as the onset of active uterine contractions or rupture of membranes. Intrapartum referral to an obstetrician-led care setting was defined as a referral after the onset of labour and before birth. The planned place of birth was defined as that at the onset of labour. Therefore, women who were referred, during pregnancy and before labour, to obstetrician-led care could not have a birth planned in midwife-led care.

Interventions

The following primary outcome variables concerning interventions were examined: the rates of episiotomy in vaginal births; AROM, and postpartum administration of oxytocin. Data about AROM and postpartum administration of oxytocin were only available in the midwifery part of the perinatal database and were therefore not described for the obstetrician-led care group.

Adverse outcomes

Secondary neonatal and maternal outcomes were: antepartum and intrapartum stillbirth; neonatal mortality up to seven days; Apgar score below seven at five minutes; third or fourth degree perineal tear among vaginal births; and postpartum haemorrhages (PPH) of more than 1,000 ml.

Data analysis

The differences between primary outcomes per region were analysed initially as a whole and then in subgroups of women in midwife-led or in obstetrician-led care, at the onset of labour and at the time of birth. Crude rates were given separately for nulliparous and multiparous women since rates of interventions are not comparable for these groups. The analyses were conducted on the level of the women, with the region as independent variable, and the primary or secondary outcome as dependent variable. In the logistic regression analyses, the overall rate of the outcome we investigated, weighted for the number of women per region, was considered as a reference. Univariable analyses were conducted in order to gain insight into the variations in the rates of primary and secondary outcomes among the twelve regions. These were followed by multivariable logistic regression analyses with adjustments for: maternal age (<40 years, 40 years or older); ethnic background (Dutch, non-Dutch); socioeconomic position (low, medium or high)—based on postal code and education, employment and level of income; and the degree of urbanisation (rural, intermediate or urban)—based on women’s residential postal code (Statistics Netherlands). A confidence interval of 99% was chosen to account for multiple testing within a large dataset. The aim of these analyses was to explore differences between the regions, which are not explained by maternal characteristics, but may be explained by variations between care professionals and/or care settings such as midwifery practices and hospitals. Therefore, we did not perform multilevel analyses.

Figures with maps of the regions and boxplots with adjusted odds ratios (ORs) and confidence intervals were used to visualise the results. To test whether variables with a significant regional variation correlated with each other, a Spearman’s rank correlation coefficient was calculated. Correlations in the 12 regions with rho ≥ 0.57 or ≤ - 0.57 corresponded with a p-value of 0.05, and a correlation of rho ≥ 0.60 or ≤ - 0.60 was considered strong [31]. Statistical analyses were performed using SPSS Statistics 22 (SPSS Inc, Chicago, IL, USA).

Results

Overall variation

The total number of women in this study was 614,730. The number of women in midwife- or obstetrician-led care at the onset of labour and at the time of birth, for nulliparous and multiparous women separately, are presented in Fig 1. Maternal characteristics have previously been published [23]. Fig 2 shows that the largest regional variations for the use of episiotomy and postpartum administration of oxytocin, were found in women who received midwife-led care at the time of birth. Adjustments for maternal age, ethnic background, socioeconomic position and the degree of urbanisation did not lead to substantial changes in regional variation. Therefore, we have shown the adjusted ORs only in the supplementary tables. Lower rates of episiotomy and postpartum administration of oxytocin were found in regions where home births were more common (rho = - 0.60 and—0.79, respectively; S2 Table).

Fig 1

Study population.

Fig 2

A. Interregional variation in adjOR* of number of women in midwife-led care at time of birth. * Adjusted for parity, maternal age, ethnic background, socioeconomic position and urbanisation. B. Interregional variation in adjOR* of actual home births. * Adjusted for parity, maternal age, ethnic background, socioeconomic position and urbanisation. C. Interregional variation in adjOR* of episiotomy. * Adjusted for parity, maternal age, ethnic background, socioeconomic position and urbanisation. D. Interregional variation in adjOR* oxytocin postpartum among women in midwife-led care. * Adjusted for parity, maternal age, ethnic background, socioeconomic position and urbanisation.

Variations in referral and place of birth

Table 1 shows the rates of the primary outcomes for each region. In nulliparous women, variations in regions were found of between 84% and 93% for being in midwife-led care at the onset of pregnancy, of between 47% and 61% at the onset of labour, and of between 17% and 26% at the time of birth. These rates were similar for multiparous women, with the exception that there were higher levels for women receiving midwife-led care at the time of birth, with a variation of between 33% and 43%. Correlations are shown in S2 and S3 Tables, which are available in the supplementary material on the web. In regions with more women in midwife-led care at the onset of labour, there were more births in midwife-led care (rho = 0.84) and more home births (rho = 0.69; S2 Table).

Table 1

Primary outcomes: Process of care and intervention rates by region.

All nulliparous women
	Total	GR	FR	DR	OV	FL	GD	UT	NH	ZH	ZL	NB	LB
Total n	276,701	8,901	9,564	6,785	18,051	7,233	30,961	23,662	49,582	63,785	4,853	38,544	14,780
Women in midwife-led care, %
At onset of pregnancy	88.5	90.4	92.5	90.6	90.0	90.5	91.2	92.4	89.9	83.6	89.5	89.1	83.7
At onset of labour	55.7	54.4	59.8	52.5	57.4	55.2	60.2	60.7	59.8	52.0	55.7	52.6	46.7
At time of birth	21.8	21.7	25.6	19.1	24.8	17.8	23.8	21.9	23.0	22.6	25.1	17.2	17.4
Planned place of birth, %
Home	16.7	17.8	30.1	19.1	26.2	16.7	24.5	16.3	15.1	12.4	6.8	15.0	10.5
Hospital/birth centre midwife-led	30.0	33.5	26.1	30.5	25.2	34.1	28.4	35.2	33.9	29.9	30.5	26.4	25.7
Hospital obstetrician-led	44.2	45.6	40.2	47.5	42.6	44.8	39.7	39.3	39.9	47.8	44.2	47.3	53.2
Other/unknown	9.1	3.1	3.6	2.8	5.9	4.4	7.4	9.3	11.1	9.9	18.5	11.3	10.5
Actual place of birth*, %
Home	9.8	11.3	15.8	10.3	14.0	9.3	14.4	9.6	10.1	7.4	5.5	7.7	7.3
Hospital/birth centre midwife-led	10.9	10.0	9.5	8.7	10.3	8.4	8.9	11.5	11.6	13.5	18.9	8.6	9.7
Hospital obstetrician-led	79.2	78.6	74.7	81.1	75.7	82.3	76.7	78.9	78.3	79.1	75.6	83.7	83.1
Episiotomy in vaginal births, %	47.4	42.1	44.4	49.2	52.0	39.1	47.4	43.2	38.9	49.4	59.9	54.7	55.7
All multiparous women
	Total	GR	FR	DR	OV	FL	GD	UT	NH	ZH	ZL	NB	LB
Total n	338,029	10,540	13,004	9,090	24,818	10,228	40,325	29,231	56,366	75,788	6,474	45,643	16,522
Women in midwife-led care, %
At onset of pregnancy	84.1	84.8	88.6	83.6	86.8	83.3	87.0	88.1	84.9	79.7	84.4	84.2	79.2
At onset of labour	52.0	49.3	55.5	47.8	55.2	48.6	56.9	56.0	54.5	49.5	52.3	47.9	46.1
At time of birth	38.4	37.9	42.7	34.9	42.6	33.5	43.0	40.7	39.9	37.2	41.9	32.8	33.9
Planned place of birth, %
Home	20.5	21.1	32.0	22.1	29.4	19.4	28.6	20.4	19.3	16.5	10.8	17.4	13.5
Hospital/birth centre midwife-led	23.7	24.9	19.4	23.6	19.6	24.0	21.9	27.9	26.5	24.1	26.0	22.2	21.4
Hospital obstetrician-led	47.9	50.7	44.5	52.2	44.8	51.4	43.1	44.0	45.3	50.3	47.7	52.0	53.8
Other/unknown	7.9	3.3	4.1	2.1	6.2	5.2	6.4	7.7	8.9	9.1	15.5	8.3	11.3
Actual place of birth*, %
Home	21.4	22.7	30.5	20.6	28.8	21.0	29.3	21.6	20.7	17.4	15.9	17.3	17.3
Hospital/birth centre midwife-led	16.0	14.9	11.7	14.2	13.3	12.3	13.2	18.2	17.6	18.0	25.5	14.2	16.1
Hospital obstetrician-led	62.7	62.4	57.8	65.2	57.9	66.7	57.5	60.2	61.7	64.6	58.6	68.5	66.6
Episiotomy in vaginal births, %	14.8	11.9	13.4	15.1	16.6	9.9	15.3	12.4	10.4	14.8	20.2	19.8	20.6
Midwife-led care at onset of labour
	Total	GR	FR	DR	OV	FL	GD	UT	NH	ZH	ZL	NB	LB
Total n	328,009	10,013	12,901	7,884	23,922	8,942	41,401	30,601	59,750	70,023	6,068	42,040	14,464
Intrapartum transfer to obstetrician-led care, %
nulliparous	60.9	60.2	57.1	63.5	56.8	67.7	60.5	63.9	61.5	56.6	54.9	67.2	62.8
multiparous	26.1	23.1	23.0	26.9	22.8	31.1	24.4	27.3	26.8	24.8	19.7	31.6	26.5
AROM, %
nulliparous	46.9	45.3	49.5	47.9	47.3	51.6	46.8	44.4	46.9	48.1	50.0	46.1	43.3
multiparous	57.3	53.9	56.3	60.1	59.1	58.2	56.8	55.3	55.4	58.9	61.0	58.7	55.1
Midwife-led care at time of birth
	Total	GR	FR	DR	OV	FL	GD	UT	NH	ZH	ZL	NB	LB
Total n	189,060	5,912	7,985	4,461	14,962	4,706	24,600	17,014	33,578	42,223	3,922	21,557	8,140
Postpartum administration of oxytocin, %
nulliparous	76.0	59.0	71.6	74.1	69.9	76.7	68.8	80.3	73.2	80.7	88.2	81.4	85.3
multiparous	69.1	50.3	61.6	70.1	60.0	72.9	61.8	72.4	66.7	73.5	84.6	77.0	80.3
Episiotomy, %
nulliparous	23.4	17.0	19.4	25.9	32.9	13.8	23.4	19.1	14.4	26.2	41.7	28.1	31.6
multiparous	7.0	4.8	5.7	7.2	9.5	3.4	7.3	5.3	4.0	6.8	12.5	10.5	9.7
Obstetrician-led care at time of birth
	Total	GR	FR	DR	OV	FL	GD	UT	NH	ZH	ZL	NB	LB
Total n	421,847	13,477	14,512	11,375	27,678	12,712	46,372	35,665	71,249	96,023	7,368	62,386	23,030
Episiotomy in vaginal births, %
nulliparous	55.7	50.8	55.4	56.0	59.7	45.7	56.5	51.4	48.2	57.3	67.4	61.6	61.9
multiparous	20.9	17.3	20.6	20.4	23.3	13.9	22.6	18.5	15.9	20.4	27.2	25.5	27.8

GR = Groningen; FR = Friesland; DR = Drenthe; OV = Overijssel; FL = Flevoland; GD = Gelderland; UT = Utrecht; NH = Noord-Holland; ZH = Zuid-Holland; NB = Noord-Brabant; LB = Limburg. These regions are the twelve provinces in the Netherlands.

Percentage of missing data: 0.0% for women in midwife-led care at onset of pregnancy, 0.6% for women in midwife-led care at onset of labour, 0.6% for women in midwife-led care at time of birth, 0.4% for planned place of birth, 0.6% for actual place of birth, 0.0% for transfer to obstetrician-led care during labour, 3.8% for artificial rupture of membranes, 4.2% for episiotomy, 3.7% for oxytocin postpartum.

* Due to some missing values in the actual place of birth variable, the rates of actual home birth and midwife-led birth in a hospital or birth centre do not add up to the total rate of women in midwife-led care at time of birth.

Adjusted ORs of variations in the rates of primary outcomes can be found in S1 Table. Adverse neonatal and maternal outcomes have been described in a previous article [23]. A visualisation of the adjusted ORs is provided in Figs 2–7. Fig 3 shows that in eight regions the number of women in midwife-led care at the onset of labour was negatively correlated with intrapartum referral rates to obstetrician-led care, but the overall correlation was not significant (rho = - 0.40; S2 Table). Rates of intrapartum referrals from midwife-led to obstetrician-led care varied from between 55% to 68% for nulliparous and from between 20% to 32% for multiparous women (Table 1). The correlations are shown in S3 Table. In regions where referral rates were higher, rates of PPH were higher as well (rho = 0.74; S3 Table). Rates of planned home births varied from between 7% to 30% among nulliparous and from between 11% to 32% among multiparous women. For actual home birth, rates varied from between 6% to 16% among nulliparous and from between 16% to 31% among multiparous women (Table 1). Planned and actual home birth were strongly correlated with each other (rho = 0.98; S2 Table).

Fig 7

Interregional variation in artificial rupture of membranes in midwife-led care at onset of labour.

Fig 3

Interregional variation in midwife-led care at onset of labour and intrapartum referral* to obstetrician-led care.

* Referral to obstetrician-led care during labour: Only women in midwife-led care at the onset of labour are shown. The reference category (OR of 1.0) is the weighted overall rate of the country.

Variations in childbirth interventions

There was a considerable north-south divide with regard to the place of birth, episiotomy and postpartum administration of oxytocin. Rates of home births were higher in the north of the country than in the south (Fig 2), and were negatively correlated with episiotomy (rho = - 0.60; S2 Table).

Rates of postpartum administration of oxytocin among women in midwife-led care at the time of birth varied from between 59% to 88% among nulliparous women and from between 50% to 85% among multiparous women (Table 1). Overall, among women in midwife-led care, the correlation of actual home birth and postpartum administration of oxytocin was rho = - 0.79 (Fig 4). In regions where midwives more frequently administer oxytocin postpartum, overall rates of PPH were not lower (rho = 0.08; S3 Table).

Fig 4

Interregional variation in actual home birth and oxytocin postpartum in midwife-led care.

The reference category (OR of 1.0) is the weighted overall rate of the country.

For episiotomy, a variation of between 39% and 60% was found in nulliparous women, and of between 10% and 21% among multiparous women. Variation was greatest for women receiving midwife-led care at the time of birth, with rates varying from between 14% to 42% among nulliparous women and from between 3% to 13% among multiparous women. Among women receiving obstetrician-led care, rates varied from between 46% to 67% among nulliparous women and from between 14% to 28% among multiparous (Table 1). There was a strong correlation between episiotomy rates in midwife-led and in obstetrician-led care settings within the same region (rho = 0.96, Fig 5). The correlation between the adjusted ORs of actual home birth and episiotomy was rho = - 0.60 (S2 Table). We did not find a correlation between the adjusted ORs of episiotomy and third or fourth degree perineal tear in vaginal births (rho = - 0.20; S3 Table and Fig 6A and 6B).

Fig 5

Interregional variation in episiotomy in vaginal births at the time of birth.

The reference category (OR of 1.0) is the weighted overall rate of the country.

Fig 6

A. Crude incidences of episiotomy and 3rd/4th degree perineal tear for nulliparous women with vaginal births. Correlation between adjusted ORs of episiotomy and of 3rd/4th degree perineal tear among all women is rho = - 0.20. B. Crude incidences of episiotomy and 3rd/4th degree perineal tear for multiparous women with vaginal births. Correlation between adjusted ORs of episiotomy and of 3rd/4th degree perineal tear among all women is rho = - 0.20.

Least variation was found for AROM among women receiving midwife-led care at the onset of labour (Fig 7). Here rates varied from between 43% to 52% among nulliparous women and from between 54% to 61% among multiparous (Table 1). Except for the positive correlation between intrapartum referral and PPH (rho = 0.74), correlations with other adverse outcomes were not statistically significant.

Discussion

This study is a first step towards understanding the appropriate use of interventions in childbirth, as was recommended in a Lancet series on Midwifery [2]. Most variation was found in the use of episiotomy and postpartum administration of oxytocin in women receiving midwife-led care at the time of birth. These intervention can be applied in both home and hospital births, but lower rates were found in regions with more home births. Although there was a correlation between episiotomy use in midwife-led care and episiotomy use in obstetrician-led care, the variation between regions in episiotomy rates was greater for women receiving midwife-led care. A finding we believe to be significant was the negative correlation that was found in two-thirds of the regions between the number of women in midwife-led care at the onset of labour and intrapartum referral rates. The only correlation that we found with adverse neonatal and maternal outcomes was between intrapartum referral and PPH; there were higher rates of PPH in regions with more intrapartum referrals, which did not include referrals after birth. Significantly, in our study, no correlation was found between the regional adjusted ORs for episiotomy, and third or fourth degree rupture.

Limitations and strengths

A limitation of this study is the absence, or low quality of other relevant data in the register such as the maternal body mass index, congenital disorders, and history of obstetric complications. However, adjustments for maternal age, ethnic background, socioeconomic position and degree of urbanisation did not lead to considerable changes in ORs. Therefore, it is unlikely that regional variation in underlying morbidity, including variation in indications for interventions, would explain entirely the variations observed. Reporting bias is an issue for datasets based on national registers [30] but we have no indication that misclassifications are different across regions. The number of missing values was very low; there were no outcome variables with more than 1.5% of values missing, and no characteristic variables with more than 2.5% of values missing.

Additionally, the correlation coefficients calculated are only a crude indicator of the relevant and significant correlations between variables, since it was not possible to account for confidence intervals by calculating Spearman’s correlation coefficients of adjusted ORs.

A major strength of this study was access to data of the total population of women in the Netherlands who gave birth in the four-year study period. Furthermore, we were able to differentiate between outcomes for women receiving midwife-led and obstetrician-led care, at the onset of labour and at the time of birth. In this manner, the distinction could be made between groups of women at a low and those at a higher risk of complications. This makes confounding by indication less likely. While not all twelve regions have a university hospital, the analyses were based on the women’s residential postal code instead of the postal code of the place of birth, thus the presence or absence of a university hospital in a region will have had a limited influence on the results. However, other confounders, such as distance to a hospital, may have had an influence upon the outcomes and may explain, in part, some variations. Correlations which were investigated in this study cannot be interpreted as causal relationships. Further research is needed to examine whether causality exists for the associations found.

Interpretation and further research

Interpretation in view of previous literature

Previous studies on regional variations in other countries, showed a variety in intervention rates across studies. When focusing on the subjects of our study, we found lower rates and less variation in rates of AROM, and, similar to our results, large variations in episiotomy rates. Studies were found on regional variations in episiotomy and AROM in Brazil, Ireland, Canada, and France, but there is a lack of literature on regional variations in care processes. A Brazilian study, including 23,940 women, found rates of AROM varying from between 32% to 48%, and episiotomy rates varying from 49% to 69% across five regions, although variation in episiotomy rates was only significantly different in the region with the highest incidence [32]. The episiotomy rate in a study in Ireland, including 323,588 births, varied from between 19% to 27% across four regions, and the rate of AROM varied from between 5% to 9% [33]. A study on variation across 13 regions in Canada, including 8,244 women, found varying episiotomy rates of between 5% to 24% [34]. A variation of between 1% and 34% was found for episiotomy rates in non-instrumental births across many regions in France, in a study including national data [35].

A result in our study which we believe to be significant is the north-south divide within the country. In northern regions, rates of home births were higher and rates of episiotomy in the total population and postpartum oxytocin administration in midwife-led care were lower. It is unlikely that this can be entirely explained by the different risk profiles of low-risk women giving birth at home, compared to low-risk women giving birth in a hospital or a birth centre. Fewer intrapartum referrals to obstetrician-led care might be expected in regions with fewer women in midwife-led care at the onset of labour because women with higher risks may already have been referred earlier during their pregnancy. Yet, our results showed the opposite for two-thirds of all regions. These findings may be explained by regional policies oriented towards obstetrician-led care, or by the preferences of women which may require more referrals. In regions with higher referral rates, PPH rates were higher as well, which may be explained by the association that was found between the augmentation of labour and PPH in our previous publication [23]. Offerhaus et al. (2015) described a similar correlation [15]. Previous studies showed non-urgent referrals, such as meconium-stained amniotic fluid, need for pain medication and/or delay in progress of first stage of labour, being the main reasons for intrapartum referrals in the Netherlands [15, 36]. Our findings of varying rates of intrapartum referral, which may be correlated with higher PPH rates requires further investigation, before any conclusions in terms of policy with regard to augmentation of labour may be drawn.

Several important bodies, such as the WHO, and the series on Caesarean section and Midwifery in the Lancet, have called for action to reduce the inappropriate use of medical interventions in maternity care. Large regional variation that is not explained by differences in maternal characteristics may be unwarranted. There is a lack of literature on regional variations in interventions, related to place of birth and other care processes. It is important to give more insight in the existing variation to care providers and policy makers, to motivate for reflection on their practice policies, on remarkable high or low rates, and on possible causes of variation. This study is therefore an important step in the reduction of unwarranted variation.

Possible explanations of variations in referrals and interventions

Many studies have investigated midwives’ and obstetricians’ perceptions of risk and uncertainty surrounding clinical practice behaviours. They showed that perceived higher risk or uncertainty is associated with higher rates of interventions [37-39] and intrapartum referrals [40]. Care providers’ perceptions of risk or uncertainty may also have an impact upon the preferences of childbearing women. Perceptions among care providers may vary due to differences in education—in particular between different countries—underlying social history and various developments in attitudes towards interventions during childbirth over time and culture [37, 38, 41]. Variations are not merely individual, since care providers are influenced by the culture of their working environment [42]. Similar variations in rates of episiotomy between women in midwife-led care versus those in obstetrician-led care, within the same region, may be explained by a number of factors including: the impact of regional guidelines; comparable attitudes towards interventions during childbirth; and the influence different care providers have upon each other with regard to which care strategies are preferred within a region [37, 38, 42]. Considerable variation between regions with regard to rates of intrapartum referrals, episiotomy and postpartum administration of oxytocin, particularly in midwife-led care, may indicate lack of national consensus about indications for these practices. Further research into the factors which may influence the clinical practice behaviours mentioned above is needed to identify the underlying causes, attitudes towards interventions during childbirth, and the perception of risk [41].

Episiotomy

The routine use of episiotomy is not recommended in recent literature [43] or by the World Health Organization (WHO) [44], because it can lead to physical problems such as a lower pelvic floor muscle strength, dyspareunia and perineal pain [3]. The WHO recommends restricting episiotomy in normal labour to a rate of ten per cent [44], but there are no national guidelines on indications for episiotomy in the Netherlands. An episiotomy rate of 60% for all nulliparous women, found in one of the regions, suggests that this intervention is not performed in a restrictive manner [43]. Since rates of adverse neonatal and maternal outcomes in regions with high episiotomy rates were not lower, such major variation might indicate that episiotomy has been overused in some regions. This warrants further investigation. In our study, a correlation between the regional adjusted ORs for episiotomy, and third or fourth degree perineal tears was not found. In addition, regional variation in performing an episiotomy was considerably larger than the variation in severe perineal tears. An episiotomy is often performed to prevent severe perineal tears [43, 45]. However, literature supports other methods to reduce the rate of third or fourth degree tears which do not have adverse effects [46-48].

Artificial rupture of membranes

AROM may reduce the length of time of labour [4] and it might, therefore, decrease the need for augmentation of labour with oxytocin [4]. On the other hand, some concerns about possible adverse effects have been suggested [4, 49]. The WHO states there should be a valid reason for the artificial rupturing of the membranes in normal labour [44], but there are no national guidelines on indications for AROM in the Netherlands. The average incidence of AROM in our study (47% for nulliparous and 57% for multiparous women in midwife-led care at the onset of labour) was relatively high compared to for instance Germany, where the incidence is 34% and 42% respectively [50]. However, its variation was limited, suggesting a consensus in the use of AROM among midwives. More research is needed to investigate appropriate rates of AROM [4, 44].

Postpartum administration of oxytocin

The large regional variation of postpartum oxytocin among low-risk women, that was found in our study, suggests a lack of a national consensus in midwife-led care. As described by the WHO, the administration of oxytocin seems beneficial for reducing the risk of PPH [44, 51]. Our study suggests underuse of oxytocin in the Netherlands in some regions. This may be explained by some midwives, particularly in regions with low rates, not being convinced of the benefits of routine oxytocin for low-risk women [52], and they may be concerned about potential side effects that have been highlighted in literature [5]. As has been argued before [5], we recommend further research into the use of routine administration of postpartum oxytocin among low-risk women and to develop a national guideline on this issue.

Conclusions

High rates and large variations were found for intrapartum referral, indicating differences in risk perception between care providers. A correlation was found between intrapartum referral and PPH. More research is required into factors influencing care providers’ decision to refer a woman during labour. Higher rates in the use of episiotomy in the total population and postpartum administration of oxytocin in midwife-led care were found in regions with fewer home births. These were not accompanied by better maternal and neonatal outcomes. It seems that existing evidence for restricted use of episiotomy has not been implemented in clinical practice in the Netherlands and large variations in rates of episiotomy and postpartum administration of oxytocin suggest lack of national consensus with regard to these practices. In the short-term, care providers should reflect on their episiotomy practice and restrict the use of episiotomy to evidence-based indications. In the longer-term, policy makers in midwife-led and obstetrician-led care at the national level should achieve consensus on indications for episiotomy and postpartum administration of oxytocin. Further research is needed to identify the reasons for these differences in intervention rates, to explore ways of reducing possibly avoidable interventions, and acquiring evidence-based consensus on the use of interventions.

Multivariable logistic regression of process of care and intervention rates by region, adjusted* OR [99% CI].

*odds ratios, adjusted for parity, maternal age, ethnic background, socioeconomic position and urbanisation.

(DOCX)

Click here for additional data file.

Correlations between process of care variables and interventions.

All correlations are based on adjusted ORs of the intervention rates (adjusted for parity, maternal age, ethnic background, socioeconomic position and urbanisation). A p-value of 0.05 corresponds with a correlation of rho ≥ 0.57 or ≤ - 0.57 (95% confidence intervals 0.001–0.86). Since the sample size for all measured correlations is the same, namely 12 regions, the correlation is significant at the same value of rho for all measured correlations. Correlations with rho ≥ 0.60 or ≤ - 0.60 are indicated in bold type since they are considered strong.

(DOCX)

Click here for additional data file.

Correlations between process of care variables or interventions, with obstetric outcomes.

All correlations are based on adjusted ORs of the intervention rates (adjusted for parity, maternal age, ethnic background, socioeconomic position and urbanisation). Correlations for still birth and mortality are not calculated since these were not significantly different between the regions. A p-value of 0.05 corresponds with a correlation of rho ≥ 0.57 or ≤ - 0.57 (95% confidence intervals 0.001–0.86). Since the sample size for all measured correlations is the same, namely 12 regions, the correlation is significant at the same value of rho for all measured correlations. Correlations with rho ≥ 0.60 or ≤ - 0.60 are indicated in bold type since they are considered strong.

(DOCX)

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4 Jul 2019

Submitted filename: Response to Reviewers 19-18857.docx

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10 Oct 2019

PONE-D-19-18857

Regional variations in childbirth interventions and their correlations with adverse outcomes, birthplace and care provider: a nationwide explorative study

PLOS ONE

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Section Comment, question, suggestion.

Abstract 1. There was no introduction in the background, the knowledge gap is missing, which could have been reflected in the introduction (i.e. this could have helped to understand why this study was important to be undertaken)

2. No study design is reported on methods

3. Methods not clearly stated

4. Missed the policy implications and recommendations in conclusion.

Introduction

Background 1. Quantify the rates of interventions during childbirth and their variations globally to locally

2. What interventions have been done in Netherlands with respect to childbirth interventions? Are there any Strategic plans? Policies?

Literature review 3. The literature review did not follow pyramid while discussing the previous findings (i.e. provide available evidence about the topic under study from global perspective to local context)

Problem Statement 4. Missed the knowledge gap, what information is lacking/missing in the literature/what we can’t do because we don’t know the trends? (lack of the information to be provided by the present study)

5. What would we benefit from this study findings? (please state it clearly)

Justification 6. Lack of information does not justify a study to be done. (please state clearly the benefits of the study findings; to whom, why and how?)

Objectives 7. Specific objective 2 is not SMART, “We also investigated how these variations are correlated both to each other, and to adverse neonatal and maternal outcomes, adjusted for maternal characteristics.” (this is two in one, it can be separated to make it more specific)

Methodology 1. What was the reason of focusing only on single births?

2. How was confounding controlled for?

3. Individuals from the same facility may have the same characteristics (may be clustered within the facility), how did you account for the clustering effect?

Results 1. Childbirth interventions need to be clearly defined and clearly presented

2. Neonatal and maternal adverse outcomes should be clearly defined

Discussion 1. Missed the comparisons between the study findings and available literature's (similarities & differences)

2. Missed the link of the results and possible explanations basing on what policies, interventions, changes in guidelines were in place at the time.

Strengths and limitations 3. Did the missing values affect study results? if YES what could be the direction of bias?

4. Were there any forms of bias in the study? if YES how these might have influenced the present findings?

5. What is the contribution of the present study to the scientific community?

Conclusion 6. The recommendations were not action oriented (i.e. state clearly, what recommendation, to whom with what action (taking into account the availability of resources): short term and long term action

7. What should be the way forward now that we have the study findings?

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Submitted filename: summary of the report- Childbirth Interventions.docx

Click here for additional data file.

29 Oct 2019

22 October 2019

Dear dr. Michael Johnson Mahande,

Please find enclosed our revised paper entitled ‘Regional variations in childbirth interventions and their correlations with adverse outcomes, birthplace and care provider: a nationwide explorative study’ (PONE-D-18-17816). We appreciate that we received the opportunity to revise our manuscript. We thank the editors for the constructive comments. We will address the suggestions one by one, referring to the line numbers. In the manuscript, changes are highlighted in red.

We previously published a related manuscript entitled ‘Regional variations in childbirth interventions in the Netherlands: a nationwide explorative study’ in BMC Pregnancy and Childbirth (doi: 10.1186/s12884-018-1795-0).

When reading the journal requirements, we realized that our Data Availability statement needs to be changed. Our data is available only on request at the Dutch perinatal register “Perined”, and therefore, we are not allowed to provide the data by ourselves. Can you please change the statement into “Data cannot be shared publicly because of restrictions of the perinatal register "Perined". Data are available from Perined (contact via info@perined.nl) for researchers who meet the criteria for access to confidential data, and if Perined gives permission.”

Response to comments

Abstract

1. There was no introduction in the background, the knowledge gap is missing, which could have been reflected in the introduction (i.e. this could have helped to understand why this study was important to be undertaken).

We added the knowledge gap in the abstract. The background section of the abstract is now stating:

Page 2, lines 25-28:

“Variations in childbirth interventions may indicate inappropriate use. Most variation studies are limited by the lack of adjustments for maternal characteristics and do not investigate variations in adverse outcomes. This study aims to explore regional variations in the Netherlands and their correlations with referral rates, birthplace, interventions and adverse outcomes, adjusted for maternal characteristics.”

2. No study design is reported on methods

We added the following phrase in the methods section of the abstract:

Page 2, line 31:

“In this nationwide retrospective cohort study, using a national data register…”

3. Methods not clearly stated

We added the following phrase in the methods section of the abstract:

Page 2, line 36:

“…with Spearman’s rank correlation coefficients.”

4. Missed the policy implications and recommendations in conclusion.

We added the following sentence in the conclusion section of the abstract:

Page 3, lines 51-52:

“Care providers and policy makers need to be aware of reducing unwarranted variation in birthplace, episiotomy and the postpartum use of oxytocin.”

Introduction/background

5. Quantify the rates of interventions during childbirth and their variations globally to locally.

We added rates of home births, referral, and episiotomy worldwide and in the Netherlands.

Page 4, lines 62-74:

“Worldwide, rates of most interventions and referrals during childbirth have increased [6, 11, 12], episiotomy being the exception [6, 14]. The rate of home births varies worldwide and is low in most high-income countries. For instance, in 2017, the rate of home births was 1% in the USA [15], 0.3% in Australia [16], and 2% in England and Wales [17]. The rate of referrals depends on the maternity care system in a country. Alliman et al. (2016) showed a range of intrapartum referral rates from birth centres to hospitals of between 12% and 37% [18], and Blix et al. (2014) a referral rate range from home to hospital of between 10% and 32% [19]. Episiotomy rates vary largely, from 5% in Denmark, to 75% in Cyprus [20].

In the Netherlands, a variation in intrapartum referral rates among midwifery practices has been shown of between 10% and 64% [21]. Since the late twentieth century, referrals during pregnancy and labour have increased continuously. Where in 1999 more than 60% of women received midwife-led care at the onset of labour, this number has decreased to 51% in 2015 [22, 23]. The rate of home births has historically been high in the Netherlands. However, the rate of home births declined from 23% in 2000 to 13% in 2015 [22, 23]. Episiotomy rates declined from 23% in 2005 to 13% in 2015 in the Netherlands.”

6. What interventions have been done in Netherlands with respect to childbirth interventions? Are there any Strategic plans? Policies?

In the Netherlands, the focus in national policy has been on reducing perinatal mortality. The Steering Committee ‘Pregnancy and Childbirth’ recommended in 2009 more integration in maternity care between midwife-led and obstetrician-led care, which led to several not overarching coordinated initiatives in the field of maternity care.

The Dutch Organisation of Midwives is aware of the high rate of episiotomy in the Netherlands and has offered intervision sessions for midwives to reflect on their indications for performing an episiotomy in 2017.

We added the following sentences in box 1 on page 5:

“In 2009, the Steering Committee ‘Pregnancy and Childbirth’ recommended more integration in maternity care between midwife-led and obstetrician-led care, which led to several not overarching coordinated initiatives in the field of maternity care [13].”

Literature review

7. The literature review did not follow pyramid while discussing the previous findings (i.e. provide available evidence about the topic under study from global perspective to local context).

We changed the order in the introduction section, added several sentences, and made changes in the following paragraph.

Page 4, lines 62-74:

“Worldwide, rates of most interventions and referrals during childbirth have increased [6, 11, 12], episiotomy being the exception [6, 14]. The rate of home births varies worldwide and is low in most high-income countries. For instance, in 2017, the rate of home births was 1% in the USA [15], 0.3% in Australia [16], and 2% in England and Wales [17]. The rate of referrals depends on the maternity care system in a country. Alliman et al. (2016) showed a range of intrapartum referral rates from birth centres to hospitals of between 12% and 37% [18], and Blix et al. (2014) a referral rate range from home to hospital of between 10% and 32% [19]. Episiotomy rates vary largely, from 5% in Denmark, to 75% in Cyprus [20].

In the Netherlands, a variation in intrapartum referral rates among midwifery practices has been shown of between 10% and 64% [21]. Since the late twentieth century, referrals during pregnancy and labour have increased continuously. Where in 1999 more than 60% of women received midwife-led care at the onset of labour, this number has decreased to 51% in 2015 [22, 23]. The rate of home births has historically been high in the Netherlands. However, the rate of home births declined from 23% in 2000 to 13% in 2015 [22, 23]. Episiotomy rates declined from 23% in 2005 to 13% in 2015 in the Netherlands.”

Problem statement

8. Missed the knowledge gap, what information is lacking/missing in the literature/what we can’t do because we don’t know the trends? (lack of the information to be provided by the present study)

9. What would we benefit from this study findings? (please state it clearly).

We believe the following sentence of our introduction section clearly explains the knowledge gap. We added a sentence on the benefits from our study findings.

Page 6, lines 100-102:

“Little information is available as to how regional variations in rates of referral, place of birth, and interventions during childbirth, relate to each other, nor how they might relate to adverse neonatal and maternal outcomes.”

Page 6, lines 102-106:

“Knowledge on these correlation will give insight into underlying processes of variations in childbirth interventions, place of birth, and referral, and will help care providers and policy makers to know which variation is large and likely unwarranted and should therefore be the focus of changes in practices and policies with the ultimate aim to improve the quality of maternity care.”

Justification

10. Lack of information does not justify a study to be done. (please state clearly the benefits of the study findings; to whom, why and how?)

See the response to comments 8 and 9.

Objectives

11. Specific objective 2 is not SMART, “We also investigated how these variations are correlated both to each other, and to adverse neonatal and maternal outcomes, adjusted for maternal characteristics.” (this is two in one, it can be separated to make it more specific).

We separated our research aim into three aims.

Page 6, lines 107-112:

“The first aim of this study was to explore which regional variations in intrapartum rates of referral, place of birth, and use of intrapartum interventions, exist for women who gave birth in the Netherlands between 2010 and 2013. Secondly, we aimed to investigate how these variations are correlated to each other. Thirdly, we examined the association between variations, and adverse neonatal and maternal outcomes, adjusted for maternal characteristics.”

Methodology

12. What was the reason of focusing only on single births?

We focused on single births because multiple pregnancies are associated with much higher risks of adverse outcomes and therefore medical interventions are often justified. Most unwarranted variation in interventions occur among women at low risk of complications. Therefore, we only focused on single births.

Page 6, line 117-119:

“We focused on single births because multiple pregnancies are associated with much higher risks of adverse outcomes and therefore medical interventions are often justified.”

13. How was confounding controlled for?

The analyses were conducted on the level of the 614,730 women. The region was the independent variable in the analyses, and the primary or secondary outcome was the dependent variable. In the multivariable analyses, we adjusted for baseline characteristics, because these could differ across the regions and could therefore have been an explanation of the variation.

We added some sentences in the data analyses section to make clearer how our analyses were conducted.

Page 8, lines 157-166:

“The analyses were conducted on the level of the women, with the region as independent variable, and the primary or secondary outcome as dependent variable. In the logistic regression analyses, the overall rate of the outcome we investigated, weighted for the number of women per region, was considered as a reference. Univariable analyses were conducted in order to gain insight into the variations in the rates of primary and secondary outcomes among the twelve regions. These were followed by multivariable logistic regression analyses with adjustments for: maternal age (<40 years, 40 years or older); ethnic background (Dutch, non-Dutch); socioeconomic position (low, medium or high) - based on postal code and education, employment and level of income; and the degree of urbanisation (rural, intermediate or urban) - based on women’s residential postal code (Statistics Netherlands).”

14. Individuals from the same facility may have the same characteristics (may be clustered within the facility), how did you account for the clustering effect?

We had the following considerations for not performing multilevel analyses to adjust for clustering.

The aim of our study is to describe and explore which variations exist and how variations in interventions or processes relate to each other and to adverse outcomes. These variations might (partly) be explained by clustering of women in care facilities (birth centre, hospital, midwifery practice) and care providers. Variations in clinical practice that are not explained by differences in obstetric risks or preferences of women, may be unwarranted. If we would conduct multilevel analyses, we would adjust for the differences between care providers or other levels. However, these variations are exactly the topic of our study and we do not want control for them. Future research should use multilevel analyses to investigate whether differences between care facilities and care providers may explain the variations between regions, but that is beyond the scope of our study.

Results

15. Childbirth interventions need to be clearly defined and clearly presented.

16. Neonatal and maternal adverse outcomes should be clearly defined.

We added three subtitles in the manuscript under the subheading ‘Selection of variables’:

- Care processes

- Interventions

- Adverse outcomes

The outcome measures were defined as follows:

Page 7-8 , lines 131-151:

“Care processes

The following primary outcome variables concerning maternity care processes were examined: the number of women receiving midwife-led care at the onset of their pregnancy, at the onset of labour, and at the time of birth; intrapartum referral to obstetrician-led care, and the planned, and actual place of birth (home, hospital and birth centre midwife-led, hospital obstetrician-led). The onset of labour was defined as the onset of uterine contractions or rupture of membranes. Intrapartum referral to an obstetrician-led care setting was defined as a referral after the onset of labour and before birth. The planned place of birth was defined as that at the onset of labour. Therefore, women who were referred, during pregnancy and before labour, to obstetrician-led care could not have a birth planned in midwife-led care.

Interventions

The following primary outcome variables concerning interventions were examined: the rates of episiotomy in vaginal births; AROM, and postpartum administration of oxytocin. Data about AROM and postpartum administration of oxytocin were only available in the midwifery part of the perinatal database and were therefore not described for the obstetrician-led care group.

Adverse outcomes

Secondary neonatal and maternal outcomes were: antepartum and intrapartum stillbirth; neonatal mortality up to seven days; Apgar score below seven at five minutes; third or fourth degree perineal tear among vaginal births; and postpartum haemorrhages (PPH) of more than 1,000 ml.”

Discussion

17. Missed the comparisons between the study findings and available literatures (similarities & differences).

We added a paragraph on previous literature on regional variations in the discussion section.

Pages 18-19, lines 317-327:

“Previous studies on regional variations in other countries, showed a variety in intervention rates across studies. When focusing on the subjects of our study, we found lower rates and less variation in rates of AROM, and, similar to our results, large variations in episiotomy rates. Studies were found on regional variations in episiotomy and AROM in Brazil, Ireland, Canada, and France, but there is a lack of literature on regional variations in care processes. A Brazilian study, including 23,940 women, found rates of AROM varying from between 32% to 48%, and episiotomy rates varying from 49% to 69% across five regions, although variation in episiotomy rates was only significantly different in the region with the highest incidence [32]. The episiotomy rate in a study in Ireland, including 323,588 births, varied from between 19% to 27% across four regions, and the rate of AROM varied from between 5% to 9% [33]. A study on variation across 13 regions in Canada, including 8,244 women, found varying episiotomy rates of between 5% to 24% [34]. A variation of between 1% and 34% was found for episiotomy rates in non-instrumental births across many regions in France, in a study including national data [35].”

18. Missed the link of the results and possible explanations basing on what policies, interventions, changes in guidelines were in place at the time.

Criteria for referral from midwife-led to obstetrician-led care have been laid out in the obstetric indication list of 2003.

Page 5, box 1:

“Criteria for referral from midwife-led to obstetrician-led care have been laid out in the obstetric indication list of 2003.“

However, it is possible that regional protocols differ. In the following (added) parts of the discussion section we suggest that differences in policies and culture may lead to variations in interventions.

Page 19, lines 338-341:

“Yet, our results showed the opposite for two-thirds of all regions. These findings may be explained by regional policies oriented towards obstetrician-led care, or by the preferences of women which may require more referrals.”

Page 20, lines 366-373:

“Similar variations in rates of episiotomy between women in midwife-led care versus those in obstetrician-led care, within the same region, may be explained by a number of factors including: the impact of regional guidelines; comparable attitudes towards interventions during childbirth; and the influence different care providers have upon each other with regard to which care strategies are preferred within a region [37, 38, 42]. Considerable variation between regions with regard to rates of intrapartum referrals, episiotomy and postpartum administration of oxytocin, particularly in midwife-led care, may indicate lack of national consensus about indications for these practices.”

Page 20, lines 380-382:

“The WHO recommends restricting episiotomy in normal labour to a rate of ten per cent [44], but there are no national guidelines on indications for episiotomy in the Netherlands.”

Page 21, lines 395-397

“The WHO states there should be a valid reason for the artificial rupturing of the membranes in normal labour [44], but there are no national guidelines on indications for AROM in the Netherlands.”

Page 22, lines 410-411:

“…we recommend further research into the use of routine administration of postpartum oxytocin among low-risk women and to develop a national guideline on this issue.”

Strengths and limitations

19. Did the missing values affect study results? if YES what could be the direction of bias?

Missing values were very few in number, and therefore we do not think that they influenced the results. We changed this as follows:

Page 16-17, line 300-302:

“The number of missing values was very low; there were no outcome variables with more than 1.5% of values missing, and no characteristic variables with more than 2.5% of values missing.”

20. Were there any forms of bias in the study? if YES how these might have influenced the present findings?

We think the most important form of bias is reporting bias, which we discussed in the limitations and strengths section. Because our independent variable of interest is the region, and we do no have any indication that this reporting bias might vary across regions, we do not think that this has influenced the findings.

21. What is the contribution of the present study to the scientific community?

Several important bodies, such as the WHO, and the series on Caesarean section and Midwifery in the Lancet, have called for action to reduce the inappropriate use of medical interventions in maternity care. Large regional variation that is not explained by differences in maternal characteristics may be unwarranted. There is a lack of literature on regional variations in interventions, related to place of birth and other care processes. It is important to give more insight in the existing variation to care providers and policy makers, to motivate for reflection on their practice policies, on remarkable high or low rates, and on possible causes of variation. This is an important step in the reduction of unwarranted variation.

Page 17, lines 279-280:

“This study is a first step towards understanding the appropriate use of interventions in childbirth, as was recommended in a Lancet series on Midwifery [7].”

Page 20, lines 349-356:

“Several important bodies, such as the WHO, and the series on Caesarean section and Midwifery in the Lancet, have called for action to reduce the inappropriate use of medical interventions in maternity care. Large regional variation that is not explained by differences in maternal characteristics may be unwarranted. There is a lack of literature on regional variations in interventions, related to place of birth and other care processes. It is important to give more insight in the existing variation to care providers and policy makers, to motivate for reflection on their practice policies, on remarkable high or low rates, and on possible causes of variation. This study is therefore an important step in the reduction of unwarranted variation.”

Conclusion

22. The recommendations were not action oriented (i.e. state clearly, what recommendation, to whom with what action (taking into account the availability of resources): short term and long term action.

23. What should be the way forward now that we have the study findings?

The following sentences were added to the conclusion section:

Page 22, lines 419-422:

“In the short-term, care providers should reflect on their episiotomy practice and restrict the use of episiotomy to evidence-based indications. In regions with high episiotomy rates, care providers should focus on decreasing this rate. In the longer-term, policy makers in midwife-led and obstetrician-led care at national level should achieve consensus, on indications for episiotomy and postpartum administration of oxytocin.”

We are confident that our study is a first, important step in reducing the inappropriate use of medical interventions in maternal and newborn care, which is called for by important bodies, such as the WHO. We therefore hope that you will consider publication of our article.

We look forward to hearing from you.

Yours faithfully, on behalf of all authors,

Anna Seijmonsbergen-Schermers, MSc

3 Feb 2020

PONE-D-19-18857R1

Regional variations in childbirth interventions and their correlations with adverse outcomes, birthplace and care provider: a nationwide explorative study

PLOS ONE

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Reviewer #2: (No Response)

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Reviewer #2: Yes

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Reviewer #1: this is an interesting paper addressing regional variations in obstetrical care in The Netherlands. The paper has improved based on reviewers comments that were adequately addressed.

Reviewer #2: Re: Regional variations in childbirth interventions and their correlations with adverse outcomes, birthplace and care provider: a nationwide explorative study

I have read this manuscript within an important topic, rates of referrals and interventions, with interest. The manuscript includes a lot of information about regions, referral rates, intervention rates, and maternal and neonatal outcomes. This amount of information requires a good organisation in the paper and I think the paper is quite well organised and give valuable information. I have some comments listed below:

Introduction

• I cannot find references number 22 and 23. Please add web address or other publication details.

Methods

• I would recommend using “RS” for the Spearman rank correlation coefficient. Use of “p-value” confuses readers, I think.

Results

• Again, confusing symbol used for the correlation coefficient.

• Intrapartum referrals from midwife-led to obstetrician care seem very high, 55% to 68% for nulliparous women. Is this correct, are these referrals done during labour and birth? During active labour?

• There is a misspelling in the title for figure 4 (aArtificial).

• In the tables, GR, DR, ZL etc need explanation, I suggest under the table.

Discussion

• These results give an important message – wide variations in intervention rates depend to a large extent on different cultures in childbirth care – but I miss this message being highlighted in the conclusion. I would like to see the authors’ conclusions on referral rates.

• I am a little confused about the choice of subheadings in the Discussion section. First a summary, good, and the strengths and limitation, good. But what is meant by “Literature”? Is that a subheading or a sub-subheading after “Interpretation…”? I think this could be made clearer.

• Subheading “Possible explanation….” seems to be about referral rates – maybe include “referral rates” in the subheading would make it easier to find those discussed. Thereafter the interventions studied have separate sub-headings so why not referrals?

• I understand that it is a little complicated to get all studied factors into the conclusion but I think it is worth a try.

**********

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Reviewer #1: Yes: Marleen Temmerman

Reviewer #2: Yes: Anna Dencker

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6 Feb 2020

6 February 2020

Dear dr. Michael Johnson Mahande,

Please find enclosed our revised paper entitled ‘Regional variations in childbirth interventions and their correlations with adverse outcomes, birthplace and care provider: a nationwide explorative study’ (PONE-D-19-18857R1). We appreciate that we received the opportunity to revise our manuscript. We thank the reviewer for the constructive comments. We will address the suggestions one by one, referring to the line numbers. In the manuscript, changes are highlighted in red.

Response to comments of Reviewer 2

Introduction

- I cannot find references number 22 and 23. Please add web address or other publication details.

We added the web address of these two references.

Page 28, lines:

“22. Perined. Perinatale Zorg in Nederland 2015 Utrecht: Perined; 2016 [Accessed 03-Feb-2020]. Available from: https://assets.perined.nl/docs/980021f9-6364-4dc1-9147-d976d6f4af8c.pdf.

23. Stichting Perinatale Registratie Nederland. Perinatale Zorg in Nederland 2005 Utrecht: Stichting Perinatale Registratie Nederland; 2008 [Accessed 03-Feb-2020]. Available from: https://assets.perined.nl/docs/2f0a701a-d8f3-4cbd-98a1-2c4e588cf435.pdf.”

Methods

- I would recommend using “RS” for the Spearman rank correlation coefficient. Use of “p-value” confuses readers, I think.

We changed all “ρ-signs” into “rho” in the manuscript as well as in the table. We highlighted these changes in the manuscript.

Results

- Again, confusing symbol used for the correlation coefficient.

See our previous response.

- Intrapartum referrals from midwife-led to obstetrician care seem very high, 55% to 68% for nulliparous women. Is this correct, are these referrals done during labour and birth? During active labour?

These percentages are indeed correct. It concerns referrals between the start of labour and birth. The start of labour is defined as active uterine contractions or rupture of the membranes. The definition of intrapartum referral was described on page 8, lines 136-137 and the definition of onset of labour on lines 135-136:

“The onset of labour was defined as the onset of active uterine contractions or rupture of the membranes. Intrapartum referral to an obstetrician-led care setting was defined as a referral after the onset of labour and before birth.”

- There is a misspelling in the title for figure 4 (aArtificial).

We changed this accordingly.

Page 12, line 240:

“Fig 7. Interregional variation in Artificial rupture of membranes in midwife-led care at onset of labour”

- In the tables, GR, DR, ZL etc need explanation, I suggest under the table.

We added an explanation under the table.

Page 15, lines 247-248:

Discussion

- These results give an important message – wide variations in intervention rates depend to a large extent on different cultures in childbirth care – but I miss this message being highlighted in the conclusion. I would like to see the authors’ conclusions on referral rates.

We added the following sentences into the conclusions:

Page 22, lines 416-419:

“High rates and large variations were found for intrapartum referral, indicating differences in risk perception and possibly in childbirth care culture between care providers. A correlation was found between intrapartum referral and PPH. More research is required into factors influencing care providers’ decision to refer a woman during labour.”

- I am a little confused about the choice of subheadings in the Discussion section. First a summary, good, and the strengths and limitation, good. But what is meant by “Literature”? Is that a subheading or a sub-subheading after “Interpretation…”? I think this could be made clearer.

We changed this sub-subheading into “Interpretation in view of previous literature” on page 18, line 321.

- Subheading “Possible explanation….” seems to be about referral rates – maybe include “referral rates” in the subheading would make it easier to find those discussed. Thereafter the interventions studied have separate sub-headings so why not referrals?

We changed this heading into “Possible explanations of variations in referrals and interventions” on page 20, line 360.

- I understand that it is a little complicated to get all studied factors into the conclusion but I think it is worth a try.

We added the following sentences into the conclusions:

Page 22, lines 416-419:

“High rates and large variations were found for intrapartum referral, indicating differences in risk perception and possibly in childbirth care culture between care providers. A correlation was found between intrapartum referral and PPH. More research is required into factors influencing care providers’ decision to refer a woman during labour.”

We are confident that our study is a first, important step in reducing the inappropriate use of medical interventions in maternal and newborn care, which is called for by important bodies, such as the WHO. We therefore hope that you will consider publication of our article.

We look forward to hearing from you.

Yours faithfully, on behalf of all authors,

Anna Seijmonsbergen-Schermers, MSc

Submitted filename: Response to reviewers.docx

Click here for additional data file.

10 Feb 2020

Regional variations in childbirth interventions and their correlations with adverse outcomes, birthplace and care provider: a nationwide explorative study

PONE-D-19-18857R2

Dear Dr. Seijmonsbergen-Schermers,

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With kind regards,

Michael Johnson Mahande, PhD

Academic Editor

PLOS ONE

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Reviewers' comments:

13 Feb 2020

PONE-D-19-18857R2

Regional variations in childbirth interventions and their correlations with adverse outcomes, birthplace and care provider: a nationwide explorative study

Dear Dr. Seijmonsbergen-Schermers:

I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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