| Literature DB >> 31646629 |
Marya Plotkin1, Benjamin Kamala2, Jim Ricca1, Linda Fogarty3, Sheena Currie1, Hussein Kidanto4, Stephanie B Wheeler5.
Abstract
BACKGROUND: Using Doppler to improve detection of intrapartum fetal heart rate (FHR) abnormalities coupled with appropriate, timely intrapartum care in low- and middle-income countries (LMIC) can save lives.Entities:
Keywords: Doppler; Fetal heart monitoring; Intrapartum; Low- and middle income countries (LMIC); Pinard stethoscope
Mesh:
Year: 2019 PMID: 31646629 PMCID: PMC7004154 DOI: 10.1002/ijgo.13014
Source DB: PubMed Journal: Int J Gynaecol Obstet ISSN: 0020-7292 Impact factor: 3.561
Figure 1PRISMA flow diagram depicting systematic search strategy.
Studies on the effectiveness of FHR monitoring by Doppler to reduce perinatal mortality
| Ref. (year) | Country | Study objective | Study design | Study population | Clinical management differences | Perinatal outcome or abnormal FHR detection |
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| Uganda | To compare intermittent fetal heart monitoring between Doppler and Pinard for detection of FHR abnormalities (primary outcome), and intrapartum stillbirth and death within first 24 h of life (secondary outcomes) | Two‐arm RCT | n=1987 women at one peri‐urban hospital Doppler, n=1000 Pinard, n=987 | No differences in rate of cesarean deliveries | Higher detection of FHR abnormalities in the Doppler arm (incidence rate ratio, 1.61; 95% CI, 1.13–2.30; |
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| Tanzania | To compare intermittent fetal heart monitoring between Doppler and Pinard for detection of FHR abnormalities (primary outcome), and intrapartum stillbirth, neonatal death, time to delivery, and mode of delivery (secondary outcomes) | Two‐arm RCT | 2844 women at Tanzania's national referral hospital Doppler, n=1421 Pinard, n=1423 | No difference in time between detection of an abnormal FHR to delivery | Higher detection of FHR abnormalities in Doppler (6.0%) vs Pinard (3.9%) arm (aOR, 1.59; |
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| Zimbabwe | To compare effectiveness of CTG, intermittent monitoring with Doppler, intermittent monitoring with Pinard by a research midwife, and intermittent monitoring with a Pinard by facility midwife on detection of abnormal FHR (primary outcome) and cesarean delivery, neonatal mortality, and admission to NICU (secondary outcomes) | Four‐arm RCT Doppler for intermittent monitoring, CTG, Pinard by research midwife (gold standard), Pinard by facility midwife (routine monitoring) | n=1255 women at one urban referral hospital Doppler, n=312 Pinard by research midwife, n=310 Pinard by facility midwife, n=315 CTG, n=318 | No difference in time between detection of FHR abnormality and delivery among the 4 groups. Cesarean more common in CTG (28%) and Doppler (24%) arms than in Pinard arms with research (10%) and facility (15%) midwives. Fetal distress was indication for cesarean in 63% of CTG and 67% of Doppler arms, each significantly higher than Pinard arms (41%) | Compared with routine monitoring, RR of detecting abnormal FHR was 6.1 (95% CI, 4.2–8.8) with CTG, 3.6 (95% CI, 2.4–5.3) with Doppler, and 1.7 (95% CI, 1.1–2.7) with the Pinard/research midwife. Stillbirth or neonatal death was 3% (CTG); 0.6% (Doppler); 2% (Pinard with research midwife) and 3% (routine monitoring). Significantly fewer neonates were admitted to NICU in the Doppler vs other arms |
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| Tanzania | To compare intermittent fetal heart monitoring between Doppler and Pinard for detection of FHR abnormalities (primary outcome) and intrapartum stillbirth, neonatal death and admission to NICU within 24 h (secondary outcomes) | Two‐arm RCT | n=2684 women at one rural referral hospital Doppler, n=1309 Pinard, n=1375 | No difference in time between detection of abnormal FHR to delivery. No difference in cesarean delivery rates | Abnormal FHR detected in 4.2% of Doppler vs 3.1% of Pinard arm, not significant (RR, 1.38; 95% CI, 0.93–2.04). No difference in adverse perinatal outcomes or bag–mask ventilation between Pinard and Doppler arms |
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| Tanzania | To assess the effect of introducing continuous FHR monitoring on detection of abnormal FHR (primary outcome); and time to delivery, time from detection of abnormal FHR to delivery, and intrauterine resuscitation (secondary outcomes) | Observational pre‐ and post‐intervention | At one urban referral hospital, n=1640 women enrolled at the pre‐implementation stage and n=2442 at the implementation stage | Higher rate of cesarean observed post‐intervention (5.4%) vs pre‐intervention (2.6%) ( | Continuous FHR monitoring with Doppler (post‐intervention) was associated with 6.9‐fold increased detection of abnormal FHR vs routine FHR monitoring with Pinard (pre‐intervention) |
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| Tanzania | To compare continuous fetal heart monitoring by Doppler and intermittent monitoring by Pinard for detection of FHR abnormalities (primary outcome) and intrapartum stillbirth, neonatal death, mode of delivery, 5‐min Apgar score, bag–mask ventilation, time from abnormal FHR detection to delivery, adverse fresh stillbirth, neonatal death within 24 h, and admission to NICU (secondary outcomes) | Two‐arm RCT | n=2652 women at one rural referral hospital Doppler with continuous monitoring, n=1340 Doppler with intermittent monitoring, n=1312 | Increased rate of intrauterine resuscitations in continuous vs intermittent monitoring groups (6.6% vs 3.2%; RR 2.07, 95% CI 1.4–2.9; | Continuous FHR monitoring with Doppler detected abnormal FHR in 8.1% vs 3.0% of women in intermittent monitoring group (RR 2.64, 95% CI 1.8–3.7; |
Abbreviations: aOR, adjusted odds ratio; CI, confidence interval; CTG, cardiotocography; FHR, fetal heart rate; NICU, neonatal intensive care unit; RCT, randomized controlled trial; RR, risk ratio.
Risk of bias and strength of evidence using Cochrane criteria for assessment of bias in EPOC studies
| Study/risk of bias | Random sequence generation | Allocation concealment | Blinding of women and personnel | Incomplete outcome data | Free of selective reporting | Blinding of outcome assessment | Baseline outcomes similar | Free of contamination | Baseline similar variables |
|---|---|---|---|---|---|---|---|---|---|
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| Judgement | Unclear risk | Low risk | High risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk |
| Description | Randomized sequence generation not described | Sequentially numbered opaque sealed envelopes | Blinding of both clinicians and women not possible | Proportion of missing data unlikely to change the study result | All outcomes reported | Outcomes assessors were not blind | No outcomes at beginning of study | All arms received allocated interventions; no crossing over | No important differences in study groups ( |
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| Judgement | Unclear risk | Low risk | High risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk |
| Description | Randomized sequence generation not described | Sequentially numbered opaque sealed envelopes | Blinding of both clinicians and women not possible | Proportion of missing data unlikely to change the study result | All outcomes reported | Outcome assessors were not blind | No outcomes at beginning of study | All arms received allocated interventions; no crossing over | Baseline variables similar ( |
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| Judgement | Unclear risk | Low risk | High risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk |
| Description | Randomized sequence generation not described | Sequentially numbered opaque sealed envelopes | Blinding of both clinicians and women not possible | Completed follow‐up per protocol | All primary and secondary outcomes reported | Not possible to blind outcomes for assessors | No outcomes at beginning of study | Allocated interventions adhered to | Baseline variables were ( |
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| Judgement | Unclear risk | Low risk | High risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk |
| Description | Randomized sequence generation not described | Sequentially numbered opaque sealed envelopes | Blinding of both clinicians and women not possible | Completed follow‐up per protocol | All primary and secondary outcomes reported | Not possible to blind outcomes for assessors | No outcomes at beginning of study | Allocated interventions adhered to | Baseline variables similar ( |
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| Judgement | Unclear risk | Low risk | High risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk |
| Description | No randomization; controlled before–after study | Controlled before‐after studies | Blinding of both clinicians and women not possible | Completed follow‐up per protocol | All primary and secondary outcomes reported | Not possible to blind outcomes for assessors | All mothers had normal FHR on admission | Unlikely as the two interventions took place at different times | Imbalances adjusted in the regression models |
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| Judgement | Low risk | Low risk | High risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk |
| Description | Randomizedsequence computer‐generated by independent statistician | Sequentially numbered opaque sealed envelopes | Blinding of both clinicians and women not possible | Completed follow‐up per protocol | All primary and secondary outcomes reported | Not possible to blind outcomes for assessors | All mothers had normal FHR on admission | Allocated interventions adhered to | Adjusted for baseline imbalances by logistic regression, multinomial regression, and linear regression |
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| Judgement | High risk | High risk | High risk | Low risk | Low risk | High risk | Unclear risk | Unclear risk | Unclear risk |
| Description | No randomization; cross‐sectional study | No randomization; cross‐sectional study | No blinding; cross‐sectional study | All data obtained | All outcomes reported | No blinding because of study design | Not described | Not described | Not described |
Abbreviations: EPOC, effective practice and organization of care.
Studies on the measurement of health facility‐occurring perinatal mortality using Doppler
| Study (year) | Country | Study objective | Study design | Indicator | Definition | Data source for indicator | Population size/sample size | Key findings |
|---|---|---|---|---|---|---|---|---|
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| Pakistan, India, DRC, Kenya | To quantify the proportion of perinatal deaths that occurred in the facility setting and were potentially preventable, as a demonstration for potential scale‐up to assess quality of intrapartum care | Prospective study in which FHR was assessed by Doppler and basic information was recorded from women admitted to labor | Perinatal mortality rate per 1000 deliveries | Stillbirth and neonatal death before discharge per 1000 deliveries (stratified by occurrence in hospital, or neonate <2500 g at birth) | Personal medical record | n=3555 women and n=3593 neonates in 6 hospitals in 5 countries | Approximately 40% of perinatal mortality occurred in‐hospital, and was potentially preventable with better care. Perinatal mortality rate was 34 deaths per 1000 deliveries overall, and 13 per 1000 deliveries in‐facility. Restricted to neonates weighing 2500 g or more, perinatal mortality rate was 22 per 1000 deliveries overall, and 9.4 per 1000 deliveries in‐facility |
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| Tanzania | To validate an indicator of facility perinatal mortality by (1) comparing perinatal outcomes (macerated stillbirth, fresh stillbirth, neonatal death) as recorded in the facility register to gold‐standard audits, and (2) calculating an indicator for the study sites | A validation study in which audits were conducted on 128 perinatal deaths recorded in the health facility's national health information system register over 6 mo | Facility perinatal mortality indicator | Fresh stillbirth and very early neonatal deaths divided by all women admitted to the facility with a FHR detected | National health information system maternity register | n=9687 women admitted to labor and delivery services in 10 health facilities in the Kagera region of Tanzania; n=d128 perinatal deaths were audited to assess validity of register‐recorded classification | Sensitivity and specificity of register outcomes to predict audit outcomes ranged from 95.7% to 100%, validating the accuracy of register data for calculating the indicator. Rates of perinatal mortality occurring in‐facility ranged from 4.2% (regional hospital); 1.5%–2.7% (district hospitals); and 0.3%–0.5% (health centers); Use of Doppler on admission and recording the FHR in the register produced a more specific measure as compared with crude perinatal death rate, which included macerated stillbirth and was thus less reflective of quality of intrapartum care |
Abbreviations: DRC, Democratic Republic of Congo; FHR, fetal heart rate.
Studies related to healthcare provider or maternal preference for Doppler vs Pinard
| Study (year) | Country | Primary research question | Study design | Population | Data source | Key findings | Recommendations |
|---|---|---|---|---|---|---|---|
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| Tanzania | To describe attitudes and perceptions of women in labor continuously monitored with a strap‐on Doppler device and their perceptions of quality of intrapartum care | A cross‐sectional qualitative study; in‐depth interviews conducted within 12–24 h of delivery among women who delivered in an urban hospital | Multiparous women monitored using a continuous Doppler monitoring system during their delivery; only women with positive birth outcomes were interviewed | n=20 interviews | Use of the monitor positively affected the women's birth experience by providing reassurance about the wellbeing of the fetus. Women believed that use of the device improved care provided by the health facility staff through increased communication and attention from birth attendants; Participants were given little to no information about the purpose or functions of the device, and thus did not fully understand and often overestimated its capabilities | On the introduction of Doppler for intrapartum care, information should be included in counseling during prenatal care and/or in the early stages of labor. Information should include limitations of the device to avoid overestimation of its capabilities |
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| Tanzania | To explore midwives’ perceptions on using either Doppler, Pinard fetoscope, or Freeplay wind‐up for intermittent FHR monitoring in a rural hospital | Cross‐sectional qualitative assessment using FGDs | Midwives employed at the study hospital for at least 6 mo; trained in use of both Doppler and Pinard fetoscope | n=5 FGDs held with 25 participants | The study did not reveal a common and clear preference for Doppler vs fetoscope for FHR assessment. Three themes emerged: (1) sufficient training and experience in using a device, (2) perceived ability of devices to produce reliable measurements, and (3) convenience of use and comfort of the device | Regular training to make use of Doppler easier, and equal availability of fetoscopes and Doppler in labor wards. More research is needed to address practitioners’ preferences on best ways to conduct FHR monitoring |
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| South Africa | To document preferences on 3 methods of FHR assessment (Doppler, Pinard fetoscope, and cardiotocography) by laboring women | Cross‐sectional study based on interview with women in labor | Women in the first stage of labor. In the course of 30 min, women were assessed with wind‐up Doppler, Pinard fetoscope and cardiotocography in succession. Women were then asked to rank their first and second choice | n=97 women were interviewed | 72 of 97 women preferred Doppler for assessing FHR in the first stage of labor | FHR monitoring by Doppler was found to be more acceptable to laboring women as compared with Pinard stethoscope or cardiotocography |
Abbreviations: FGD, focus group discussion; FHR, fetal heart rate.