Risk-guided maternity care to enhance maternal empowerment postpartum: A cluster randomized controlled trial.

OBJECTIVE: To investigate whether a structured inquiry during pregnancy of medical factors and social factors associated with low socioeconomic status, and subsequent patient-centred maternity care could increase maternal empowerment.
DESIGN: Cluster-randomised controlled trial.
SETTING: This study was conducted among pregnant women in selected urban areas in the Netherlands. This study was part of the nationwide Healthy Pregnancy 4 All-2 programme. POPULATION: Pregnant women listed at one of the sixteen participating maternity care organisations between July 1, 2015, and Dec 31, 2016.
METHODS: All practices were instructed to provide a systematic risk assessment during pregnancy. Practices were randomly allocated to continue usual care (seven practices), or to provide a patient-centred, risk-guided approach to addressing any risks (nine practices) identified via the risk assessment during pregnancy. MAIN OUTCOME MEASURES: Low postpartum maternal empowerment score.
RESULTS: We recruited 1579 participants; 879 participants in the intervention arm, and 700 participants in the control arm. The prevalence of one or more risk factors during pregnancy was similar between the two arms: 40% and 39%, respectively. In our intention-to-treat analysis, the intervention resulted in a significant reduction in the odds of having a low empowerment score [i.e. the primary outcome; adjusted OR 0.69 ((95% CI 0.47; 0.99), P 0.046)].
CONCLUSIONS: Implementation of additional risk assessment addressing both medical and social factors and subsequent tailored preventive strategies into maternity care reduced the incidence of low maternal empowerment during the postpartum period. Introducing this approach in routine maternity care may help reduce early adversity during the postpartum period.

RCT Entities:   Population Interventions Outcomes

Introduction

Maternity care refers to the safe and high quality health care given in relation to pregnancy and delivery of an infant. The purpose of maternity care is manifold: providing information and emotional support, providing adequate care for mother and child, and enhancing maternal empowerment [1, 2]. Empowerment is defined as achieving self-efficacy, and it reflects the process through which people gain greater control over decisions and actions affecting their health [3]. Maternal self-efficacy is a belief held by mothers of their capabilities to perform specific tasks in taking care of the newborn. This self-efficacy, or empowerment, is an important predictor of a successful transition to motherhood [4]. Reduced self-efficacy postpartum, or a low maternal empowerment score, reduces the practice of exclusive breastfeeding, the quality of care provided to the newborn, and it increases the risk of maternal depression [4-6].

Women with a lower socioeconomic status (SES) tend to have lower self-efficacy than women with a higher SES [7-10]. This lower self-efficacy of women with a low SES may further augment their already increased risk of developing adverse maternal and child health outcomes [11-16]. As such, building women’s sense of autonomy and control may help reduce inequalities in maternal and child health outcomes resulting from factors related to a person’s SES [13, 15, 17–21].

Unfortunately, missed opportunities occur in daily practice as SES indicators and factors related to a person’s self-efficacy are insufficiently acknowledged or taken into account in the provision of maternity care [22]. Moreover, there is a consistent inequity in postpartum care provision in the Netherlands, where more care is provided to women with a higher SES, who need it less, than to women who are disadvantaged [23].

We hypothesised that a structured inquiry of medical factors and social factors associated with low SES, and subsequent patient-centred maternity care tailored to these factors during pregnancy and the postpartum period, would increase postpartum maternal empowerment.

Materials and methods

We conducted a cluster-randomised controlled trial (C-RCT) in six municipalities in the Netherlands to assess the effectiveness of a complex intervention to advance maternal empowerment in the postpartum period [24, 25]. The intervention consisted of a systematic risk assessment including both medical and social factors, and a patient-centred, risk-guided approach to address risks identified during pregnancy and the postpartum period.

This C-RCT was embedded in the national Healthy Pregnancy 4 All-2 (HP4All-2) programme [24], a successor to the HP4All-1 programme [26]. Both programmes aimed to improve perinatal health by reducing health inequalities during pregnancy and childbirth. Poor neighbourhoods in the Netherlands were the main location to reach women with a lower SES [24]. We used the CONSORT statement for C-RCTs to guide reporting of our findings, and included the CONSORT-flowchart for C-RCTs (Fig 1) [27].

Fig 1

CONSORT diagram showing flow of municipalities, maternity care organisations, and participants.

Study setting

The authors confirm that all ongoing and related trials for this intervention are registered. We registered our study with the Netherlands Trial Registry (NTR 6311) in March 2017, this was after patient enrollment had started (July 2015) but before the end of the inclusion period (August 2017). The study proposal had been reviewed by the METC Erasmus MC in March 2015. As a result of this review, the Committee informed us that the rules laid down in the Medical Research Involving Human Subjects Act (also known by its Dutch abbreviation WMO), did not apply to this research proposal.

Ethical considerations

We have obtained multi-site approval from the Daily Board of the Medical Ethics Committee Erasmus MC (METC 2015–156). Ethical approval to collaborate with the board of each municipality and with the board of maternity care organisations was provided. In addition, we obtained written informed consent from all three levels of participants. Written informed consent was obtained from every participant prior to inclusion. In addition, we obtained written informed consent from the board of every participating municipality (“Rotterdam”, “Schiedam”, “Groningen”, “Utrecht”, “Almere”, and “Arnhem”), and from the board of every participating maternity care organisation (“Kraamzorg Rotterdam”, “Careyn Kraamzorg”, “Kraamzorg Sara”, “Kraamzorg de Eilanden”, “Kraamzorg de Bakermand”, “Kraamzorg het Groene Kruis”, “de Kraamvogel”, “Zin Kraamzorg”, “Yunio”, “KraamInzicht”, “Kraamzorg de Waarden”, and “Liemerscare”).

Trial design

The study design and rationale are briefly outlined below; a detailed study protocol was previously published (S1 File) [25]. This two-arm, parallel, pragmatic C-RCT was conducted with 12 independent maternity care organisations, which were geographically spread over the Netherlands with 16 offices (Fig 2).

Fig 2

C-RCT design with intervention details.

Six out of ten municipalities within the HP4All-2 programme participated in this trial. Each municipality was divided into an intervention and a control cluster, to minimise the influence of geographical variation on the outcome measures. To avoid contamination between maternity care assistants (MCAs) working within the same maternity care organisation we allocated the intervention at the level of the maternity care organisation(s) per municipality rather than at the individual MCA or participant level. As such, a cluster could consist of multiple maternity care organisations.

Participants

All pregnant women cared for by participating maternity care organisations with a scheduled home visit during pregnancy were eligible to take part in the study. Besides the unwillingness to sign a written informed consent form, there were no exclusion criteria for participants. Eligible participants were informed about the study and written informed consent was obtained prior to inclusion [25]. Participants were enrolled between July 2015 and December 2016. Follow-up data was collected until July 2017.

Intervention and control conditions

The study included two practice changes: 1) implementation of a systematic risk assessment during pregnancy to identify medical, social and non-medical risk factors associated with adverse maternal health (control and intervention arm); and 2) provision of patient-centred care throughout pregnancy and the post-partum period by MCAs, as informed by their risk profile (intervention arm only) [25]. Participants were followed up until they were 12 weeks postpartum.

The systematic risk assessment was included in the standard home intake that is scheduled by maternity care organisations in the third trimester of pregnancy. The assessment was an electronic questionnaire and covered domains related to socioeconomic and psychological factors. The questionnaire consisted of the following components: 1) the Mind2Care (M2C) tool (a validated third trimester risk screening tool frequently used to assess psychological and psychosocial problems (www.mind2care.nl/home)); 2) the Maternal Empowerment Questionnaire (MEQ; a validated postpartum tool based on the World Health Organization (WHO) Responsiveness model used to assess the performance of maternity care based on clients' experiences [28]) with slight adjustments; and 3) additional questions regarding socioeconomic status, including questions regarding a person’s financial situation, whether they have health care insurance, and their use of health care in the year prior to pregnancy Minor adjustments were made to ensure that the MEQ, which was originally designed to assess empowerment in the postpartum period, could be applied during pregnancy: the domains ‘the future’ and ‘maternity care’ were omitted, and minor grammatical adjustments were made in the remaining items as appropriate [25].

To properly carry out the risk assessment, professionals were trained in two separate sessions, each three hours long, referred to as ‘Training Session 1a and 1b’ (Fig 2). All trained professionals were MCAs, skilled nurses who have a lower secondary education degree for postpartum care. The first and core training was held prior to the start of participant enrolment and focused on effective use of the risk assessment tool and on building communication skills (Training 1a). The second training, after the first month of participant enrolment, was aimed at refreshing the obtained knowledge and providing a platform for discussing possible implementation issues that were encountered during patient enrolment (Training 1b). An established national educational organisation (“Kersten & van de Pol”) assisted the research team in providing these training sessions [25]. Maternity care professionals who completed both Training Session number 1a and number 1b, and who enrolled participants in the study, are henceforth referred to as ‘local researchers’.

For the second part (i.e. the actual intervention under study), the provision of patient-centred risk-tailored maternity care during the postpartum period, training sessions were held for all MCAs in the intervention arm prior to the start of the study (Training Session number 2). This training session covered knowledge and skills enabling MCAs to provide advice for additional care, to tailor maternity care provision to the individual needs and the existing resources of a participant, and to strengthen participants’ own capabilities. Another established national educational organisation, (“Voorlichters Gezondheid”), assisted the research team in delivering Training Session 2. In addition to this accredited training session, templates were introduced to guide an MCA into taking appropriate action once a risk factor was identified. As such, each template served as a care pathway by directing the MCAs to, for example, a specific health care provider (i.e. midwife, obstetrician, or general practitioner), a public health care organisation, or an office for legal or financial support.

As an example, the template for addressing the risk factor ‘irredeemable financial debts’ guided the local researcher into taking the following actions during pregnancy: creating awareness among involved health care professionals (e.g. community midwife, general practitioner, MCAs) and applying for local funds that supply free postpartum packages consisting of, among other things, nappies and sanitary pads. In the control arm, professionals were blinded for the outcome of the risk assessment and they provided conventional care during pregnancy and the postpartum period (Fig 2).

Outcomes

We hypothesised that our intervention would reduce the proportion of women with a low empowerment score postpartum. As such, the primary outcome was a low maternal empowerment score in the early postpartum period, between one to two weeks after childbirth, as assessed by the validated MEQ [29]. A low empowerment score was defined as a MEQ-score beneath the 20th centile (rounded at one decimal) of empowerment scores in the control arm. Secondary outcome measures pertain to maternal health-related quality of life, maternal perceived health, maternal psychological health, maternal and neonatal health care utilisation postpartum, maternal smoking behaviour, and alcohol consumption during the late postpartum period, up and until twelve weeks after childbirth (S1 Table).

MCAs in the intervention arm filled out a questionnaire during the participant’s early postpartum period. This questionnaire assessed the MCAs’ understanding of the participant’s obtained risk profile during pregnancy, and the relevance of the detected risk-profile for the care that they provided during the postpartum period.

All MCAs filled out the Measurement Instrument for Determinants of Innovations (MIDI); an instrument that measures determinants of innovations [30] at the end of the study period to assess the delivery of the intervention.

Randomisation, implementation, and blinding

S1 Fig summarises the chronology of events, blinding, and any differences between the two arms [31]. The timeline cluster diagram is complementary to the CONSORT-flowchart for C-RCTs (Fig 1) [27]. At the start of the study, maternity care organisations were identified and recruited. Clusters were formed and consisted of one or more distinct maternity care organisations, depending on the expected number of eligible women within each organisation. Randomisation was then performed at the cluster level. A statistician who was not involved in the implementation of the trial and who was blinded to the identity of the clusters performed the randomisation procedure. After randomisation of the clusters, all eligible women received study information at first contact with a maternity care organisation and prior to the scheduled home visit. Hence, participants were blinded for allocation because they were unaware of the randomised design of the study, and as such of the alternative strategy. Blinding of MCAs and local researchers was not feasible due to the training related to our intervention. Therefore, recruitment of participants, the following baseline assessment, execution of the experimental intervention during pregnancy and the postpartum period, as well as outcome assessments in the postpartum period were partially blinded; the participant was unaware of the randomised design but the MCA was aware of the outcome of allocation.

Sample size

An initial sample size of 1711 participants was calculated using an alpha of 0.05, a power of 80%, and assuming a lost to follow-up of 33% [25]. To adjust for clustering, an Intraclass Correlation Coefficient (ICC) of 0.05 was assumed in this sample size calculation, as is common in studies involving primary care practices [32, 33].

Statistical methods

Impact of the intervention

Descriptive data were compared to identify major differences between the two arms in baseline characteristics, pregnancy outcomes, and in uptake of maternity care.

Mixed-effects models were used to adjust for clustering within the (clusters of) maternity care organisations. Analyses were conducted with random effect for clusters only (‘unadjusted models’), and additionally adjusted for selected covariates (‘adjusted models’). Selection of covariates was based on a stepwise backward elimination using the Wald test and keeping a p value of 0.20 as a threshold for elimination. ‘Parity’ (multiparous vs primiparous), and ‘single parenthood’ (living without a partner) were fixed prior to the stepwise modelling as these variables are incorporated in the national protocol for determining the amount of postpartum care provision and as such may affect maternal empowerment postpartum [22]. Multilevel mixed-effects logistic regression was used for binary outcomes, multilevel mixed-effects linear regression was used for continuous outcomes, and multilevel mixed-effects ordered regression was used for categorical outcomes. The main analyses were undertaken on an intention-to-treat (ITT) basis. The observed intraclass correlation coefficient was calculated using the adjusted model for the primary outcome.

Subgroup analysis. To assess whether there was a differential effect of the intervention on maternal empowerment according to whether risk factors had been identified during pregnancy, a subgroup analysis on participants with at least one identified factor was performed.

Post-hoc analysis. A higher-than-anticipated attrition rate was observed during the trial. In an attempt to address this we applied multiple imputation using chained equations, creating 20 unique datasets, to account for loss to follow-up and missing information [34]. Both predictor and outcome variables were included to inform the multiple imputation process and results across the sets were combined using Rubin’s Rules [35]. A post-hoc sensitivity analysis using the multiple imputed data was performed to check whether this attrition rate affected the effect estimates of the primary outcome.

For all analyses, nominal significance level was 5%; with no adjustment for multiple testing. Analyses were performed using Stata version 15.

Determinants of the delivery of the intervention

To evaluate the delivery of the intervention in the postpartum period, MCAs were asked to indicate if they were aware that a risk factor had been identified during pregnancy, and if they agreed that this detected risk had indeed been present throughout the postpartum period. To evaluate the determinants of implementation all local researchers were asked to fill out the MIDI questionnaire. The response scale consisted of a five point scale; ‘totally disagree’, ‘disagree’, ‘neither agree nor disagree’, ‘agree’, and ‘totally agree’. All outcomes regarding these determinants of implementation are reported as frequencies and percentages.

Results

Cluster and participant flow

Sixteen maternity care offices from 12 independent maternity care organisations were recruited. In the intervention group, one maternity care office discontinued the intervention before participant enrolment due to difficulties with using electronic questionnaires (Fig 1). A total of 76 professionals from maternity care offices in both arms were recruited and trained extensively completing both Training Session 1a and 1b. All local researchers participated throughout the study period. Additionally, in the intervention arm, 385 MCAs were trained in Session number 2 and participated in the provision of patient-centred, risk-based maternity care during pregnancy and the postpartum period.

Together, the 15 maternity care offices that participated throughout the study period included 1579 participants: 879 participants in the intervention arm, and 700 participants in the control arm. Enrolment of participants stopped after December 2016 according to protocol [25].

Follow-up data from the early postpartum period, between one to two weeks after childbirth, was available for 469 participants (53%) in the intervention arm and 311 (44%) in the control arm (follow-up for both arms; 49%, attrition 51%). For all participants with follow-up data from the early postpartum period, data from the consecutive late postpartum period, six through twelve weeks after childbirth, was available for 304 participants (64%) in the intervention arm and 170 participants (54%) in the control arm (overall follow-up for both arms; 30%, attrition 70%) (Fig 1).

Participants who were lost to follow-up during the early and late follow-up period more often: were first or second generation immigrants (early: 40% versus 24%; late: 37% versus 21%), had a low disposable household income (early 17% versus 7%; late 15% versus 6%), and were without a paid job during pregnancy (early follow-up 26% versus 17%; late follow-up 26% versus 12%) (S2 Table).

Participant characteristics

Baseline characteristics assessed during pregnancy were similar for participants in the intervention and the control arm (Table 1); this similarity was also observed between clusters (S3 Table). The percentage of participants who had one or more risk factor(s) identified during pregnancy was similar between both arms: 40% and 39% in the intervention and the control arm, respectively (S4 Table). The most frequent risk factors were: fear for upcoming delivery (intervention 37%; control 34%); a self-reported concern about being prepared for care provision for the baby (intervention 27%; control 27%); and inadequate health literacy (intervention 17%; control 20%). Data regarding pregnancy outcomes and uptake of maternity care were available for 1445 participants (92%). There were no relevant differences in pregnancy outcomes or in the provided amount of maternity care between the intervention arm and the control arm (Table 2).

Table 1

Individual-level baseline characteristics assessed during pregnancy.

	Intervention (n = 879)		Control (n = 700)
	Mean	SD	Mean	SD	p-value
Maternal age*	31.5	4.8	31.7	4.4
	N	%	N	%
Parity
Primiparous	446	50.7%	360	51.4%	0.786
Multiparous	433	49.3%	340	48.6%
Parenthood
Single	20	2.3%	31	4.4%	0.016
Living together	859	97.7%	669	95.6%
Immigrant status
Non-immigrant	595	68.7%	468	67.1%	0.057
First generation	135	15.6%	97	13.9%
Second generation	136	15.7%	132	18.9%
Missing	13	1.5%	3	0.4%
Health insurance
No	1	0.1%	1	0.1%	0.872
Yes	878	99.9%	699	99.9%
Education
Lower	50	5.7%	43	6.1%	0.925
Intermediate	538	61.2%	428	61.1%
High	291	33.1%	229	32.7%
Net household income (euro/month)
<1500	95	10.8%	95	13.6%	0.245
1500–3000	338	38.5%	260	37.1%
>3000	446	50.7%	345	49.3%
Paid job during pregnancy
No	201	22.9%	145	20.7%	0.304
Yes	678	77.1%	555	79.3%
Neighbourhood deprivation
No	517	58.8%	370	52.9%	0.018
Yes	362	41.2%	330	47.1%
Smoking during pregnancy
No	762	86.7%	602	86.0%	0.692
Yes	117	13.3%	98	14.0%
Alcohol use during pregnancy
No	693	78.8%	565	80.7%	0.358
Yes	186	21.2%	135	19.3%
Drug use during pregnancy
No	867	98.6%	689	98.4%	0.734
Yes	12	1.4%	11	1.6%
Risk factors detected
No	527	60.0%	424	60.6%	0.645
Yes	352	40.0%	276	39.4%
Indicated hours of maternity care
24–49 hours	691	82%	571	84%	0.569
>49 hours	153	18%	106	16%
Missing	34	4%	23	3%

Mean* with SD or number with % (presented as percentage of non-missing values). Missing value percentage of total.

Table 2

Pregnancy outcomes and maternity care uptake postpartum.

	Intervention (n = 812)		Control (n = 633)
	N	%	N	%	p-value
Gender newborn
Male	423	52.1%	303	47.9%	0.111
Female	389	47.9%	330	52.1%
Caesarean section
No	704	86.7%	541	85.5%	0.501
Yes	108	13.3%	92	14.5%
Preterm delivery
No	783	96.4%	609	96.2%	0.825
Yes	29	3.6%	24	3.8%
Low birth weight (<2500 grams)
No	773	96.0%	601	95.7%	0.757
Yes	32	4.0%	27	4.3%
Missing	7	0.9%	5	0.8%
Provided hours of postpartum care
<24 hours	69	8.7%	43	6.9%	0.223
24–49 hours	476	59.8%	391	62.4%
>49 hours	251	31.5%	193	30.8%
Missing	16	2.0%	6	0.9%

Number with % (presented as percentage of non-missing values). Missing value percentage of total.

Impact of the intervention

A low empowerment score in the early postpartum period was observed in 19.2% and 25.4% of all participants in the intervention and control arm, respectively. The intervention resulted in a significant reduction in the odds of having a low empowerment score [unadjusted OR 0.69 ((95% CI 0.48;0.99), P 0.047); adjusted OR 0.69 ((95% CI 0.47; 0.99), P 0.046)] (Table 3).

Table 3

Impact of the intervention on primary and secondary outcomes.

Primary and secondary outcomes
		Proportions		OR (95% CI1)	aOR (95% CI)
	N	Intervention	Control
Complete cases
Early postpartum period
Primary outcome
Low empowerment score	711
Yes		19	25	0.69 (0.48; 0.99)*	0.69 (0.47; 0.99)*
Secondary outcomes
Maternal health related quality of life, cont.	763
mean (SE2)		0.82 (0.13)	0.83 (0.13)	-0.01 (-0.03; 0.14)	-0.01 (-0.04; 0.11)
Maternal perceived health, cont.	775
mean (SE)		76.80 (13.1)	76.43 (12.0)	0.35 (-2.06; 2.76)	-0.07 (-1.99; 1.84)
Late postpartum period
Secondary outcomes
Maternal psychological health	474
EPDS3>12		5	5	0.90 (0.35; 2.30)	0.85 (0.31; 2.38)
Maternal health care utilisation	413
One visit		21	34	0.63 (0.32; 1.22)	0.68 (0.35; 1.32)
Multiple visits		10	5
Hospital admission		3	3
Neonatal health care utilisation	428
One visit		12	12	1.29 (0.89; 1.89)	1.32 (0.89; 1.94)
Multiple visits		28	30
Hospital admission		6	7
Smoking late postpartum period	447
Yes		6	5	1.13 (0.49; 2.56)	0.96 (0.40; 2.28)
Alcohol use late postpartum period	300
Yes		39	32	1.34 (0.91; 2.00)	1.40 (0.94; 2.10)
Subgroup analysis: at least one risk factor in assessment
Low empowerment score	412
Yes		21	30	0.64 (0.40; 1.01)	0.61 (0.38; 0.98)*
Post-hoc analysis: imputed dataset
Low empowerment score	711
Yes		20	23	0.83 (0.61; 1.12)	0.82 (0.60; 1.10)

Number of complete cases per outcome (N) with proportions (out of 100) of primary and secondary outcomes; presented by early and late postpartum period (column: First) and by primary and secondary outcomes (second). Results from the multilevel mixed-effects logistic regression and multilevel mixed-effects ordered logistic regression are presented as (unadjusted) OR with 95% CI (first), and adjusted OR (aOR) with 95% CI (second). Results from multilevel mixed-effects linear regression are marked as cont. (continuous) and presented as β with 95% CI. Adjustment for parity, parenthood, household income, and educational attainment. Significant results are marked by an *.

195% CI; 95% Confidence Interval.

2SE; Standard Error.

3EPDS; Edinburgh Postnatal Depression Scale.

Analyses of predefined secondary outcomes showed no significant effects of the intervention on maternal health-related quality of life, perceived health, psychological health, maternal- and neonatal health care utilisation postpartum, and maternal smoking behaviour and alcohol consumption during the postpartum period (Table 3).

Subgroup analysis

The impact of the intervention on the incidence of a low maternal empowerment score was mainly attributable to its impact among participants with one or multiple identified risks during pregnancy (n = 412): aOR 0.61 ((95% CI 0.38; 0.98), P 0.043). There was no demonstrable effect of the intervention in the subgroup of women without identified risks during pregnancy (n = 368): aOR 0.78 ((95% CI 0.43; 1.41), P 0.407).

Post-hoc sensitivity analysis

Following imputation of missing data, the incidence of a low empowerment score was 20% and 23% in the intervention and control group, respectively. The estimated proportions of all predefined outcomes were more alike between the two arms in the imputed data than in the observed data (Table 3).

Within the post-hoc analysis using imputed data, the impact of the intervention was smaller than in the complete dataset and no longer statistically significant [OR 0.83 ((95% CI 0.61; 1.12); P 0.228); aOR 0.82 (95% CI 0.60; 1.10); P 0.182)].

Determinants of the delivery of the intervention

Delivery of the intervention during the postpartum period

Of all participants in the intervention arm for whom follow-up data were available, 90% (n = 420) had a response from the MCA who provided maternity care to them. Of these participants, 55% (n = 233) had one or multiple identified risk factor(s) during pregnancy. The response from the MCAs indicated that they were aware of these risks in only 30% (n = 70) of all care provisions. Among those aware, 79% (n = 55) agreed that this risk factor had influenced the content of their care. This low awareness of MCAs was mostly due to lack of communication between MCAs responsible for care during pregnancy and those responsible for the postpartum period, as reported in the MIDI instrument.

Determinants of implementation of the intervention

At the end of the study period, 52 out of 76 trained local researchers (68%) filled out the MIDI questionnaire assessing the determinants of implementation of the intervention. Local researchers reported an overall positive feeling regarding the intervention. Sixty-seven percent of all local researchers agreed that the procedural clarity of the intervention was good, 56% agreed that the intervention was based on factually correct knowledge (i.e. the correctness of the intervention itself), and 57% reported a good compatibility of the intervention with their values and standard working patterns. When asked if they believed that the intervention was relevant for their client, only 8% disagreed. However, the evaluated determinants that were associated with themselves, as the adapting person, were scored less positively. Twenty-one percent of all local researchers reported little to no personal gain from the intervention with regard to improving their standard working patterns. Only 30% agreed with the following statement: “with this innovation I achieved risk-based, patient-centred care during pregnancy and the postpartum period”.

Discussion

This pragmatic C-RCT indicates that a structured risk assessment, including social and other non-medical determinants of health, followed by patient-centred maternity care may help reduce the incidence of low maternal empowerment during the postpartum period. This effect was particularly seen among high-risk women, as detected by the assessment during pregnancy. Diminishing low empowerment postpartum may reduce the presence of significant stress, depressive symptoms, and improve the quality of care provided to the newborn, hereby minimising early adversity and existing inequalities in postpartum care.

This trial has several strengths. It contains several positive key characteristics of pragmatic trials: 1) comparison of a clinically relevant alternative to current practice; 2) a diverse and representative population of study participants; 3) heterogeneous practice settings similar to those where the aspired preventive care is to be set out; and 4) collection of data on a broad range of health outcomes [36, 37]. Furthermore, with this large scale randomised trial we are the first to evaluate the effectiveness of risk-guided, patient-centred care in increasing maternal self-efficacy.

In addition, analysis of determinants of implementation showed that the different intervention components were acceptable by local researchers from participating maternity care organisations. The combination of the good acceptability from health care professionals and the possibility of reducing low maternal empowerment scores, supports the potential for introducing this approach. Given that low maternal empowerment is associated with an increased risk of developing adverse maternal and child health, this intervention has the potential to reduce persisting inequalities in maternal and child health outcomes.

When interpreting our findings, a number of limitations also need to be taken into account. First, there was a considerable and selective loss to follow-up that has introduced a bias in our data. The loss to follow-up rate was particularly high among the less advantaged participants (S2 Table), a phenomenon that is often observed in clinical trials [38-40]. To address the resulting amount of missing data, including missing outcomes, we used multiple imputation. Baseline characteristics that were related to the loss to follow-up were included to inform the imputation model. However, concerns about validity persist because multiple imputation does not work well when data is missing not at random, hence producing biased estimates [41]. This complicated interpretation of the contrasting findings of the analyses of the imputed versus the original data, as both could be biased.

Second, the calculated sample size of 1711 participants was not achieved, possibly reducing the accuracy of our results. Formulas for calculating appropriate sample size in C-RCTs traditionally include inflation with the Variance Inflation Factor (VIF). This factor is calculated by multiplying the number of participants per cluster with the ICC [32, 33]. For our initial sample size calculation we anticipated an ICC of 0.05 [25]. However, the observed ICC from our primary model was negligible (ICC = 3.21 e-15), and as such the correlation between clusters was much less than expected. Sample size calculations using the observed rather than the anticipated ICC, together with the higher than expected attrition rate would have resulted in a lower required sample size (i.e. a total of 784 participants).

Third, the observed fidelity of our intervention was low, which might have affected its effectiveness [42]. We had intended to have MCAs tailor their maternity care to the identified risk factors in pregnancy. However, in only 40% of all postpartum care provisions that involved participants in whom risk factors had been identified during pregnancy, the MCA reported to be aware of these risks. This was unexpected, because due to the extensive training prior to the start of the intervention, all MCAs were accustomed with the importance of risk assessment and centring their care to meet these risks and the participants’ own resources and capabilities. A possible explanation for the low fidelity might be the perceived little personal gain for professionals with regard to improving their standard working patterns.

Fourth, although the reduction in low empowerment scores in the intervention arm was statistically significant, it may not reflect a clinically important difference. Overall, women had a strong sense of self efficacy during the initial assessment, and the difference in median scores between the two groups was small. Although the validity and reliability of the MEQ have been reported before as good [29], the questionnaire has not been tested on its responsiveness to change and the size of what may be considered a clinically meaningful difference has not been established.

Research has shown that it is challenging to show benefit of universally provided home visits regarding the wellbeing of mothers and babies, as underlined by the review of Yonemoto and colleagues [43]. They concluded that interventions aiming to improve maternal health outcomes in the postnatal period might be effective if subpopulations with a higher risk would be targeted [43]. It is in this regard important to note that we have previously demonstrated that low-SES women are less likely to receive postpartum care in the Netherlands, at the same time showing that lack of maternity care is associated with increased subsequent health care costs [23]. Hence, we intended to address a specific subpopulation of high-risk women during pregnancy, to enhance empowerment in those at overall greater risk of adverse health outcomes. Although study participants had a relatively high educational level, a high net income, and were more often non-immigrants compared to the general Dutch population, still 40% had one or more risk factors amendable to tailored care identified. Furthermore, the effect of the intervention was greatest in this subgroup of women with one or multiple risk factors, possibly reducing their risk of postpartum depression and increasing the quality of care provided to the newborn.

Future research should consider alternative designs to analyse the effectiveness of complex interventions into routine maternity care. Quasi-experimental studies or stepped-wedge trials may be better suited to assess impact of novel care adaptations. Alternatively, future research should include focus groups and interviews with women to hear from their perspective the challenges they face and the supports they need. Letting them be part of the design of the interventions could help reduce attrition and improve outcomes.

With this study, we have provided evidence that it is feasible to amend routine maternity care by introducing patient-centred informed by identification of predefined medical and non-medical risk factors, and that this may improve maternal empowerment in the postpartum period. Additional work is needed to ensure effective implementation of the different intervention aspects and to assess its efficiency.

The timeline cluster diagram.

(DOCX)

Click here for additional data file.

Outcome measures at participant level with definitions.

(DOCX)

Click here for additional data file.

Baseline characteristics for participants who were lost to-follow up by timing of follow-up (early and late postpartum period).

(DOCX)

Click here for additional data file.

Baseline characteristics, presented by cluster and by intervention allocation.

(DOCX)

Click here for additional data file.

Self-reported identified risk factors(s), by intervention allocation.

(DOCX)

Click here for additional data file.

Protocol HP4all maternity care.

(PDF)

Click here for additional data file.

CONSORT 2010 checklist of information to include when reporting a randomised trial*.

(DOC)

Click here for additional data file.

16 Mar 2020

PONE-D-19-23605

Enhancing maternal empowerment postpartum: a cluster randomised controlled trial

PLOS ONE

Dear Miss Lagendijk,

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The reviewers find the study of relevance but have raised some comments regarding the need for additional clarifications on methodological aspects and further discussion of the limitations of the work and to place the intervention in context.

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Reviewer #1: The statistical analysis, including the employment of mixed-effects models to adjust for clustering, covariates selection, and multiple imputation for missing data, were generally appropriate.

The limitation had generally been appropriately discussed and the conclusion was sufficiently conservative in view of these highlighted limitations.

I just have the following minor concerns:

Although the author has highlighted the lack of an established clinically meaningful difference for the MEQ (Line 337-339), a discussion of the possible interpretation and potential implication of a low empowerment score would be needed to inform the proper interpretation of the result by the readers.

The much less positive result from the perspective of the adapting persons (as highlight in Line 289-293), would need to be better discussed in the discussion and to be highlighted as a potential concern that needs to be recognised and addressed.

Reviewer #2: Thank you for this manuscript on maternal empowerment in the third trimester and in the first 12 weeks post-partum. I have some comments to make, whih I hope you will consider in your revision.

Line 62-66: Mention some specific mother and infant health outcomes related to self-efficacy, to help put the potential value of this intervention into context.

Line 97: Were there any exlusion criteria?

Line 104: Give some examples of the social and non-medical risk factors being identified.

Line 115: Provide more detail on what you mean by making "slight adjustments" to the questionnaire.

Line 116: You mention that professionals were trained in assessment. What was the background/profession of these professionals?

Line 226: If participants consented to follow-up at both time points, when they were approached in pregnancy, the attrition figures should also reflect this. In addition to the figures on follow-up between 2 and 12 weeks post-partum, include overall follow-up/attrition figures, i.e. 304/879 (34.6% follow-up, 65.4% attrition) and 170/700 (24.3% follow-up, 75.7% attrition). Were any reasons for dropping out of the study given by participants? Or were they simply not able to be contacted at 12 weeks post-partum?

Line 357:You mention that it is "feasible to" implement this intervention, but perhaps you could emphasise further that more work is needed before it would be advisable to implement this intervention.

Line 362: Put the abbreviations in alphabetical order.

Table 1: Can you insert p-values, to show the similarities/differences between groups?

Table 3: Can the proportions be given out of 100, rather than out of 1? Some abbreviations in the table need to be written out in full at the bottom, e.g. EPDS, SE, etc. Can significant results be indicated, to include p-values?

**********

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16 Apr 2020

Jacqueline Lagendijk

Erasmus Medical Centre

P.O. Box 2040 3000 CA Rotterdam

The Netherlands

Dr J. Heber

Editor-in-Chief

PLOS ONE

April 16th, 2020

Dear Dr Heber,

Enclosed please find our revised manuscript entitled “Enhancing maternal empowerment postpartum: a cluster randomised controlled trial” (PONE-D-19-23605). Thank you for this opportunity.

We have very carefully considered the valuable feedback from the reviewers and have revised our manuscript accordingly. In the following point-by-point reply, we first reproduce the reviewer’s feedback in full before detailing our responses in bold, and the revised parts of our manuscript in a cursive bold font. Please note that the page and line numbers refer to the manuscript with tracked changes.

Yours Sincerely,

On behalf of all authors,

Jacqueline Lagendijk, research fellow

Point by point reply;

Reviewer 1:

The statistical analysis, including the employment of mixed-effects models to adjust for clustering, covariates selection, and multiple imputation for missing data, were generally appropriate.

The limitation had generally been appropriately discussed and the conclusion was sufficiently conservative in view of these highlighted limitations.

Response: we thank the reviewer for the kind words and the time taken to provide feedback on our manuscript.

I just have the following minor concerns:

Although the author has highlighted the lack of an established clinically meaningful difference for the MEQ (Line 337-339), a discussion of the possible interpretation and potential implication of a low empowerment score would be needed to inform the proper interpretation of the result by the readers.

Response: in line with this recommendation, we have added information about the potential implications of (low) maternal empowerment to the first paragraph of the introduction.

Introduction, page 4, line 63-67.

“Maternal self-efficacy is a belief held by mothers of their capabilities to perform specific tasks in taking care of the newborn. This self-efficacy, or empowerment, is an important predictor of a successful transition to motherhood (4). Reduced self-efficacy postpartum, or a low maternal empowerment score, reduces the practice of exclusive breastfeeding, the quality of care provided to the newborn, and it increases the risk of maternal depression (4-6).”

To further aid proper interpretation of the results, we have provided some examples in the fourth paragraph of the discussion.

Discussion, page 16, line 332-337.

“This pragmatic C-RCT indicates that a structured risk assessment, including social and other non-medical determinants of health, followed by patient-centred maternity care may help reduce the incidence of low maternal empowerment during the postpartum period. This effect was particularly seen among high-risk women, as detected by the assessment during pregnancy. Diminishing low empowerment postpartum may reduce the presence of significant stress, depressive symptoms, and improve the quality of care provided to the newborn, hereby minimising early adversity and existing inequalities in postpartum care.”

The much less positive result from the perspective of the adapting persons (as highlight in Line 289-293), would need to be better discussed in the discussion and to be highlighted as a potential concern that needs to be recognised and addressed.

Response: we agree with the reviewer that the less positive perspective of the professional is an important limitation of our trial. A possible explanation for the low fidelity might be the perceived little gain for professionals’ standard working scheme, as mentioned in the method section. We have highlighted the need to do further research to increase the feasibility and efficiency of our intervention in the last paragraph op the discussion.

Discussion, page 17, line 367-374.

“Third, the observed fidelity of our intervention was low, which may have affected its effectiveness. We had intended to have MCAs tailor their maternity care to the identified risk factors in pregnancy. However, in only 40% of all postpartum care provisions that involved participants in whom risk factors had been identified during pregnancy, the MCA reported to be aware of these risks. This was unexpected, because due to the extensive training prior to the start of the intervention, all MCAs were accustomed with the importance of risk assessment and centring their care to meet these risks and the participants’ own resources and capabilities. A possible explanation for the low fidelity might be the limited personal gain experienced by professionals from the intervention with regard to improving their standard working patterns.”

Discussion, page 18, line 399-402.

“With this study, we have provided evidence that it is feasible to amend routine maternity care by introducing patient-centred care informed by identification of predefined medical and non-medical risk factors, and that this may improve maternal empowerment in the postpartum period. Additional work is needed to ensure effective implementation of the different intervention aspects and to assess its efficiency.”

Reviewer: 2

Thank you for this manuscript on maternal empowerment in the third trimester and in the first 12 weeks post-partum. I have some comments to make, whih I hope you will consider in your revision.

Response: we thank the reviewer for the time taken to provide feedback on our manuscript.

Line 62-66: Mention some specific mother and infant health outcomes related to self-efficacy, to help put the potential value of this intervention into context.

Response: we thank the reviewer for this valuable recommendation. We have elaborated more on the relation between maternal self-efficacy and health outcomes in the revised introduction. To further underline the possible adverse effects of low empowerment we have now note some related adverse outcomes to our revised discussion.

Introduction, page 4, line 63-67.

“Maternal self-efficacy is a belief held by mothers of their capabilities to perform specific tasks in taking care of the newborn. This self-efficacy, or empowerment, is an important predictor of a successful transition to motherhood (4). Reduced self-efficacy postpartum, or a low maternal empowerment score, reduces the practice of exclusive breastfeeding, the quality of care provided to the newborn, and it increases the risk of maternal depression (4-6).”

Discussion, page 16, line 332-337.

“This pragmatic C-RCT indicates that a structured risk assessment, including social and other non-medical determinants of health, followed by patient-centred maternity care may help reduce the incidence of low maternal empowerment during the postpartum period. This effect was particularly seen among high-risk women, as detected by the assessment during pregnancy. Diminishing low empowerment postpartum may reduce the presence of significant stress, depressive symptoms, and improve the quality of care provided to the newborn, hereby minimising early adversity and existing inequalities in postpartum care.”

Line 97: Were there any exlusion criteria?

Response: besides the unwillingness to sign a written informed consent form, there were no exclusion criteria for participants. There were exclusion criteria for participating maternity care organisations as listed in the study protocol. Maternity care organisations could not participate if they were not able to conduct a scheduled home visit during pregnancy for all participants. Full details about the different in- and exclusion criteria are listed in the published protocol.

Methods, page 6, line 122-127

“All pregnant women cared for by participating maternity care organisations with a scheduled home visit during pregnancy were eligible to take part in the study. Besides the unwillingness to sign a written informed consent form, there were no exclusion criteria for participants. Eligible participants were informed about the study and written informed consent was obtained prior to inclusion (25). Participants were enrolled between July 2015 and December 2016. Follow-up data was collected until July 2017.”

Line 104: Give some examples of the social and non-medical risk factors being identified.

Response: in line with this recommendation we have added some examples of social and non-medical risk factors that were assessed during pregnancy.

Methods, page 7, line 136-143.

“The questionnaire consisted of the following components: 1) the Mind2Care (M2C) tool (a validated third trimester risk screening tool frequently used to assess psychological and psychosocial problems (www.mind2care.nl/home)); 2) the Maternal Empowerment Questionnaire (MEQ; a validated postpartum tool based on the World Health Organization (WHO) Responsiveness model used to assess the performance of maternity care based on clients' experiences) with slight adjustments; and 3) additional questions regarding socioeconomic status, including questions regarding a person’s financial situation, whether they have health care insurance, and their use of health care in the year prior to pregnancy.”

Line 115: Provide more detail on what you mean by making "slight adjustments" to the questionnaire.

Response: the validated Maternal Empowerment Questionnaire, measures a woman’s empowerment postpartum. The risk assessment in this trial was undertaken during pregnancy rather than during the postpartum period, which led to the necessity to make slight adjustments. Two out of five domains of the MEQ were omitted for this assessment after consulting the authors (i.e. domains “the future” and “maternity care”) as these were not applicable during pregnancy. All other questions were grammatically adjusted for application during pregnancy, rather than after childbirth. The details about these adjustments, as listed above, are mentioned in the protocol of our trial.

Methods, page 7, line 134-146

“The systematic risk assessment was included in the standard home intake that is scheduled by maternity care organisations in the third trimester of pregnancy. The assessment was an electronic questionnaire and covered domains related to socioeconomic and psychological factors. The questionnaire consisted of the following components: 1) the Mind2Care (M2C) tool (a validated third trimester risk screening tool frequently used to assess psychological and psychosocial problems (www.mind2care.nl/home)); 2) the Maternal Empowerment Questionnaire (MEQ; a validated postpartum tool based on the World Health Organization (WHO) Responsiveness model used to assess the performance of maternity care based on clients' experiences (28)) with slight adjustments; and 3) additional questions regarding socioeconomic status, including questions regarding a person’s financial situation, whether they have health care insurance, and their use of health care in the year prior to pregnancy. Minor adjustments were made to ensure that the MEQ, which was originally designed to assess empowerment in the postpartum period, could be applied during pregnancy: the domains ‘the future’ and ‘maternity care’ were omitted, and minor grammatical adjustments were made in the remaining items as appropriate.”

Line 116: You mention that professionals were trained in assessment. What was the background/profession of these professionals?

Response: all trained professionals were Maternity Care Assistants (MCAs). MCAs are skilled nurses who have a lower secondary education degree for postpartum care. In the Netherlands, maternity care is provided by MCAs at home under supervision of the community midwife. The duration of maternity care is indexed in advance by an MCA for each woman individually during a scheduled home visit during the second or third trimester of pregnancy. Following delivery, a MCA visits and supports the family at home on a daily basis for the first eight to ten consecutive days.

Methods, page 7, line 147-153

“To properly carry out the risk assessment, professionals were trained in two separate sessions, each three hours long, referred to as ‘Training Session 1a and 1b’ (Figure 1). All trained professionals were MCAs, skilled nurses who have a lower secondary education degree for postpartum care. The first and core training was held prior to the start of participant enrolment and focused on effective use of the risk assessment tool and on building communication skills (Training 1a). The second training, after the first month of participant enrolment, was aimed at refreshing the obtained knowledge and providing a platform for discussing possible implementation issues that were encountered during patient enrolment (Training 1b).”

Line 226: If participants consented to follow-up at both time points, when they were approached in pregnancy, the attrition figures should also reflect this. In addition to the figures on follow-up between 2 and 12 weeks post-partum, include overall follow-up/attrition figures, i.e. 304/879 (34.6% follow-up, 65.4% attrition) and 170/700 (24.3% follow-up, 75.7% attrition). Were any reasons for dropping out of the study given by participants? Or were they simply not able to be contacted at 12 weeks post-partum?

Response: consent for all questionnaires was obtained at a single time point; during the scheduled home visit in the second or third trimester in pregnancy.

Unfortunately, there was a high loss to follow-up especially for the last questionnaire between six and 12 weeks postpartum. MCAs assisted participants with the first questionnaire, during the home visit. The second questionnaire was filled out during the early postpartum period when MCAs were still present on a daily basis. The third questionnaire was sent six weeks after delivery with two reminders, each after three weeks, to the home address of all participants. The lack of routine maternity care at this time point might have influenced the response from participants.

For clarification we have added the attrition rate of the different time point to the result section.

Results, page 11, line 257-262.

“Follow-up data from the early postpartum period, between one to two weeks after childbirth, was available for 469 participants (53%) in the intervention arm and 311 (44%) in the control arm (follow-up for both arms; 49%, attrition 51%). For all participants with follow-up data from the early postpartum period, data from the consecutive late postpartum period, six through twelve weeks after childbirth, was available for 304 participants (64%) in the intervention arm and 170 participants (54%) in the control arm (overall follow-up for both arms; 30%, attrition 70%) (figure 2).”

Line 357: You mention that it is "feasible to" implement this intervention, but perhaps you could emphasise further that more work is needed before it would be advisable to implement this intervention.

Response: we agree with the reviewer that more research is needed before implementing this intervention. We have highlighted the possibility to amend routine practices with a risk assessment and following tailored care throughout pregnancy and the postpartum period. However, the efficiency of the different intervention aspects need to be clarified. We have revised the last paragraph of our discussion to better highlight the limitations and the need for further research.

Discussion, page 18, line 399-402.

“With this study, we have provided evidence that it is feasible to amend routine maternity care by introducing patient-centred informed by identification of predefined medical and non-medical risk factors, and that this may improve maternal empowerment in the postpartum period. Additional work is needed to ensure effective implementation of the different intervention aspects and to assess its efficiency.

Line 362: Put the abbreviations in alphabetical order.

Response: alphabetical ordering was applied to the list of abbreviations.

Page 19, line 404-420

“ABBREVIATIONS

95% CI 95% Confidence Interval

aOR adjusted odds ratio

C-RCT Cluster-randomised controlled trial

EPDS Edinburgh Postnatal Depression Scale

ICC Intraclass correlation coefficient

ITT Intention to treat

HP4All Healthy Pregnancy 4 All

MCA Maternity care assistant

MEQ Maternal empowerment questionnaire

MIDI Measurement Instrument for Determinants of Innovations

M2C Mind2Care

OR Odds ratio

SE Standard Error

SES Socioeconomic status

VIF Variance inflation factor

WHO World Health Organisation”

Table 1: Can you insert p-values, to show the similarities/differences between groups?

Response: thank you for this recommendation, we have revised table 1 and table 2 accordingly.

Results, page 12, line 277

“Table 1: Individual-level baseline characteristics assessed during pregnancy.”

Intervention (n=879) Control (n=700)

Mean SD Mean SD p-value

Maternal age* 31.5 4.8 31.7 4.4

N % N %

Parity

Primiparous 446 50.7% 360 51.4% 0.786

Multiparous 433 49.3% 340 48.6%

Parenthood

Single 20 2.3% 31 4.4% 0.016

Living together 859 97.7% 669 95.6%

Immigrant status

Non-immigrant 595 68.7% 468 67.1% 0.057

First generation 135 15.6% 97 13.9%

Second generation 136 15.7% 132 18.9%

Missing 13 1.5% 3 0.4%

Health insurance

No 1 0.1% 1 0.1% 0.872

Yes 878 99.9% 699 99.9%

Education

Lower 50 5.7% 43 6.1% 0.925

Intermediate 538 61.2% 428 61.1%

High 291 33.1% 229 32.7%

Net household income (euro/month)

<1500 95 10.8% 95 13.6% 0.245

1500-3000 338 38.5% 260 37.1%

>3000 446 50.7% 345 49.3%

Paid job during pregnancy

No 201 22.9% 145 20.7% 0.304

Yes 678 77.1% 555 79.3%

Neighbourhood deprivation

No 517 58.8% 370 52.9% 0.018

Yes 362 41.2% 330 47.1%

Smoking during pregnancy

No 762 86.7% 602 86.0% 0.692

Yes 117 13.3% 98 14.0%

Alcohol use during pregnancy

No 693 78.8% 565 80.7% 0.358

Yes 186 21.2% 135 19.3%

Drug use during pregnancy

No 867 98.6% 689 98.4% 0.734

Yes 12 1.4% 11 1.6%

Risk factors detected

No 527 60.0% 424 60.6% 0.645

Yes 352 40.0% 276 39.4%

Indicated hours of maternity care

24-49 hours 691 82% 571 84% 0.569

>49 hours 153 18% 106 16%

Missing 34 4% 23 3%

Results, page 13, line 280.

“Table 2: Pregnancy outcomes and maternity care uptake postpartum.”

Intervention (n=812) Control (n=633)

N % N % p-value

Gender newborn

Male 423 52.1% 303 47.9% 0.111

Female 389 47.9% 330 52.1%

Caesarean section

No 704 86.7% 541 85.5% 0.501

Yes 108 13.3% 92 14.5%

Preterm delivery

No 783 96.4% 609 96.2% 0.825

Yes 29 3.6% 24 3.8%

Low birth weight (<2500 grams)

No 773 96.0% 601 95.7% 0.757

Yes 32 4.0% 27 4.3%

Missing 7 0.9% 5 0.8%

Provided hours of postpartum care

<24 hours 69 8.7% 43 6.9% 0.223

24-49 hours 476 59.8% 391 62.4%

>49 hours 251 31.5% 193 30.8%

Missing 16 2.0% 6 0.9%

Table 3: Can the proportions be given out of 100, rather than out of 1? Some abbreviations in the table need to be written out in full at the bottom, e.g. EPDS, SE, etc. Can significant results be indicated, to include p-values?

Response: in line with the recommendation of the reviewer we have given proportions out of 100, listed the abbreviations in the footnote and placed an * after all significant results.

Results, page 14, line 305.

“Table 3: Impact of the intervention on primary and secondary outcomes.”

Primary and secondary outcomes

Proportions OR (95% CI1) aOR (95% CI)

N Intervention Control

Complete cases

Early postpartum period

Primary outcome

Low empowerment score 711

Yes 19 25 0.69 (0.48; 0.99)* 0.69 (0.47; 0.99)*

Secondary outcomes

Maternal health related quality of life, cont. 763

mean (SE2) 0.82 (0.13) 0.83 (0.13) -0.01 (-0.03; 0.14) -0.01 (-0.04; 0.11)

Maternal perceived health, cont. 775

mean (SE) 76.80 (13.1) 76.43 (12.0) 0.35 (-2.06; 2.76) -0.07 (-1.99; 1.84)

Late postpartum period

Secondary outcomes

Maternal psychological health 474

EPDS3>12 5 5 0.90 (0.35; 2.30) 0.85 (0.31; 2.38)

Maternal health care utilisation 413

One visit 21 34 0.63 (0.32; 1.22) 0.68 (0.35; 1.32)

Multiple visits 10 5

Hospital admission 3 3

Neonatal health care utilisation 428

One visit 12 12 1.29 (0.89; 1.89) 1.32 (0.89; 1.94)

Multiple visits 28 30

Hospital admission 6 7

Smoking late postpartum period 447

Yes 6 5 1.13 (0.49; 2.56) 0.96 (0.40; 2.28)

Alcohol use late postpartum period 300

Yes 39 32 1.34 (0.91; 2.00) 1.40 (0.94; 2.10)

Subgroup analysis: at least one risk factor in assessment

Low empowerment score 412

Yes 21 30 0.64 (0.40; 1.01) 0.61 (0.38; 0.98)*

Post-hoc analysis: imputed dataset

Low empowerment score 711

Yes 20 23 0.83 (0.61; 1.12) 0.82 (0.60; 1.10)

29 Oct 2020

Risk-guided maternity care to enhance maternal empowerment postpartum: a cluster randomized controlled trial

PONE-D-19-23605R1

Dear Dr. Lagendijk,

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Anna Palatnik, M.D.

Academic Editor

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Reviewer #2: All comments have been addressed

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Reviewer #2: Yes

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Reviewer #2: Yes

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Reviewer #2: No

9 Nov 2020

PONE-D-19-23605R1

Risk-guided maternity care to enhance maternal empowerment postpartum: a cluster randomized controlled trial

Dear Dr. Lagendijk:

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on behalf of

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