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Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania.

ABSTRACT: Background: Intrapartum foetal heart rate (FHR) monitoring is crucial for identification of hypoxic foetuses and subsequent interventions. We compared continuous monitoring using a novel nine-crystal FHR monitor (Moyo) versus intermittent single crystal Doppler (Doppler) for the detection of abnormal FHR. Methods: An unmasked randomised controlled study was conducted in a tertiary hospital in Tanzania (ClinicalTrials.gov Identifier: NCT02790554). A total of 2973 low-risk singleton pregnant women in the first stage of labour admitted with normal FHR were randomised to either Moyo (n = 1479) or Doppler (1494) arms. The primary outcome was the proportion of abnormal FHR detection. Secondary outcomes were time intervals in labour, delivery mode, Apgar scores, and perinatal outcomes. Results: Moyo detected abnormal FHR more often (13.3%) compared to Doppler (9.8%) (p = 0.002). Time intervals from admission to detection of abnormal FHR were 15% shorter in Moyo (p = 0.12) and from the detection of abnormal FHR to delivery was 36% longer in Moyo (p = 0.007) compared to the Doppler arm. Time from last FHR to delivery was 12% shorter with Moyo (p = 0.006) compared to Doppler. Caesarean section rates were higher with the Moyo device compared to Doppler (p = 0.001). Low Apgar scores (<7) at the 1st and 5th min were comparable between groups (p = 0.555 and p = 0.800). Perinatal outcomes (fresh stillbirths and 24-h neonatal deaths) were comparable at delivery (p = 0.497) and 24-h post-delivery (p = 0.345). Conclusions: Abnormal FHR detection rates were higher with Moyo compared to Doppler. Moyo detected abnormal FHR earlier than Doppler, but time from detection to delivery was longer. Studies powered to detect differences in perinatal outcomes with timely responses are recommended.

SUBMITTER: Kamala B

PROVIDER: S-EPMC6388236 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania.

Kamala Benjamin B Kidanto Hussein H Dalen Ingvild I Ngarina Matilda M Abeid Muzdalifat M Perlman Jeffrey J Ersdal Hege H

International journal of environmental research and public health 20190124 3

<i>Background</i>: Intrapartum foetal heart rate (FHR) monitoring is crucial for identification of hypoxic foetuses and subsequent interventions. We compared continuous monitoring using a novel nine-crystal FHR monitor (Moyo) versus intermittent single crystal Doppler (Doppler) for the detection of abnormal FHR. <i>Methods</i>: An unmasked randomised controlled study was conducted in a tertiary hospital in Tanzania (ClinicalTrials.gov Identifier: NCT02790554). A total of 2973 low-risk singleton ...[more]

PMID: 30678354

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Project description:BackgroundFetal stethoscopes are mainly used for intermittent monitoring of fetal heart rate (FHR) during labor in low-income countries, where perinatal mortality is still high. Handheld Dopplers are rarely available and are dependent on batteries or electricity. The objective was to compare the Pinard stethoscope versus a new wind-up handheld Doppler in the detection of abnormal FHR.Materials and methodsWe conducted a randomized controlled study at Muhimbili National Hospital, Tanzania, from April 2013 to September 2015. Women with gestational age ≥37 weeks, cephalic presentation, normal FHR on admission, and cervical dilatation <7 cm were included. Primary outcome was abnormal FHR detection (<120 or >160 beats/min). Secondary endpoints were time to delivery, mode of delivery, and perinatal outcomes. χ2, Fisher's exact test, Mann-Whitney test, and logistic regression were conducted. Unadjusted and adjusted odds ratios were calculated with respective 95% confidence interval.ResultsIn total, 2,844 eligible women were assigned to FHR monitoring with Pinard (n=1,423) or Doppler (n=1,421). Abnormal FHRs were more often detected in the Doppler (6.0%) versus the Pinard (3.9%) arm (adjusted odds ratio =1.59, 95% confidence interval: 1.13-2.26, p=0.008). Median (interquartile range) time from abnormal FHR detection to delivery was comparable between Doppler and Pinard, ie, 80 (60,161) and 89 (52,165) minutes, respectively, as was the incidence of cesarean delivery (12.0% versus 12.2%). The incidence of adverse perinatal outcomes (fresh stillbirths, 24-hour neonatal admissions, and deaths) was similar overall; however, among newborns with abnormal FHR delivered vaginally, adverse outcomes were less incident in Doppler (7 of 43 births, 16.3%) than in the Pinard arm (10 of 23 births, 43.5%), p=0.021.ConclusionIntermittent FHR monitoring using Doppler was associated with an increased detection of abnormal FHR compared to Pinard in a low-risk population. Time intervals from abnormal FHR detection to delivery were longer than recommended in both arms. Perinatal outcomes were better among vaginally delivered newborns with detected abnormal FHR in the Doppler arm.

Project description:BACKGROUND:Hypoxia during labor contributes to 2.2 million intrapartum and early neonatal deaths each year. An additional 0.6-1.0 million cases of life-long disability occur because of fetal hypoxia during labor. It is known that fetal heart rate changes in labor correspond to hypoxia and neurologic compromise, but a reliable, low-cost method for detecting these changes is not available. In this study we sought to compare the ability of a handheld Doppler device to detect accelerations as part of the fetal scalp stimulation test and to compare the diagnostic performance of routine intermittent auscultation with auscultation that is augmented with fetal scalp stimulation. METHODS:This non-randomized, pre- and post-diagnostic trial was conducted with 568 maternal-fetus pairs at Kilimanjaro Christian Medical Center in Moshi, Tanzania. The first objective was to determine whether a handheld Doppler device could detect fetal accelerations in labor with reasonable accuracy as compared with a cardiotocography machine. We performed the fetal scalp stimulation test on 50 fetuses during labor using both a handheld Doppler and a cardiotocography machine and compared the outcomes for correlation using the kappa correlation coefficient. During the second objective, two groups of laboring women were monitored either with intermittent auscultation alone per routine protocol (N?=?251) or with intermittent auscultation augmented with fetal scalp stimulation per study protocol(N?=?267). Diagnostic accuracy of the monitoring method was determined by comparing umbilical cord blood gases immediately after birth with the predicted state of the baby based on monitoring. The analyses included sensitivity, specificity, and positive and negative predictive values. RESULTS:The prevalence of fetal acidemia ranged from 15 to 20%. Adding the fetal scalp stimulation test to intermittent auscultation protocols improved the performance of intermittent auscultation for detecting severe acidemia (pH <?7.0) from 27 to 70% (p?=?0.032). The negative predictive value of intermittent auscultation augmented with the fetal scalp stimulation test ranged from 88 to 99% for mild (pH?<?7.2) to severe fetal acidemia. CONCLUSIONS:The fetal scalp stimulation test, conducted with a handheld Doppler, is feasible and accurate in a limited resource setting. It is a low-cost solution that merits further evaluation to reduce intrapartum stillbirth and neonatal death in low-income countries. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02862925 ).

Dataset Information

Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania.

Publications

Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania.

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