Trial reportBMC pregnancy and childbirth2018
Intermittent fetal heart rate monitoring using a fetoscope or hand held Doppler in rural Tanzania: a randomized controlled trial.
Trial report in BMC pregnancy and childbirth, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01869582 (Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Systematic review of Doppler for detecting intrapartum fetal heart abnormalities and measuring perinatal mortality in low- and middle-income countries.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2020Pooled it
- Navigating the trials of a trial: lessons from ProRIDE on recruitment, retention, and follow-up in rural Africa.Trials · 2026Trial
- Magnitude, associated factors, and immediate outcomes of nonreassuring fetal heart rate status among laboring mothers in Ethiopia: a systematic review and meta-analysis.AJOG global reports · 2026Article
- Article
- Non-reassuring fetal heart rate and associated factors among laboring mothers at southern public hospitals in Ethiopia: a poisson regression model.Scientific reports · 2026Article
- Evaluating the implementation of intermittent versus continuous fetal heart rate monitoring on intrapartum care and early neonatal outcomes using causal mediational modeling.Frontiers in drug safety and regulation · 2026Article
- Factors associated with poor adherence to intrapartum fetal heart monitoring in relationship to intrapartum related death: A prospective cohort study.PLOS global public health · 2022Article
- Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.Frontiers in medical technology · 2022Review
- SaferBirths bundle of care protocol: a stepped-wedge cluster implementation project in 30 public health-facilities in five regions, Tanzania.BMC health services research · 2021Article
- Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings.Proceedings of the National Academy of Sciences of the United States of America · 2021Article
- Ultrasound Doppler fetal heart rate detection algorithm analyzes the correlation between twin selective fetal growth restriction and cord blood SFass fasL level.Pakistan journal of medical sciences · 2021Article
- A review of fetal cardiac monitoring, with a focus on low- and middle-income countries.Physiological measurement · 2020Review
- Unsupervised hidden semi-Markov model for automatic beat onset detection in 1D Doppler ultrasound.Physiological measurement · 2020Article
- Scale-Up of Doppler to Improve Intrapartum Fetal Heart Rate Monitoring in Tanzania: A Qualitative Assessment of National and Regional/District Level Implementation Factors.International journal of environmental research and public health · 2020Article
- Quality of intrapartum care: direct observations in a low-resource tertiary hospital.Reproductive health · 2020Observational
- Proportion and Associated Factors of Nonreassuring Fetal Heart Rate Patterns in Finote Selam Primary Hospital, North West Ethiopia.BioMed research international · 2020Article
- Observational
- Perceptions and experiences of skilled birth attendants on using a newly developed strap-on electronic fetal heart rate monitor in Tanzania.BMC pregnancy and childbirth · 2019Article
- Potential causes of early death among admitted newborns in a rural Tanzanian hospital.PloS one · 2019Article
- Intermittent auscultation fetal monitoring during labour: A systematic scoping review to identify methods, effects, and accuracy.PloS one · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundNeonatal mortality is a global challenge, with an estimated 1.3 million intrapartum stillbirths in 2015. The majority of these were found in low resource settings with limited options to intrapartum fetal heart monitoring devices. This trial compared frequency of abnormal fetal heart rate (FHR) detection and adverse perinatal outcomes (i.e. fresh stillbirths, 24-h neonatal deaths, admission to neonatal care unit) among women intermittently assessed by Doppler or fetoscope in a rural low-resource setting.
methodsThis was an open-label randomized controlled trial conducted at Haydom Lutheran Hospital from March 2013 through August 2015. Inclusion criteria were; women in labor, singleton, cephalic presentation, normal FHR on admission (120-160 beats/minute), and cervical dilatation ≤7 cm. Verbal consent was obtained.
resultsA total of 2684 women were recruited, 1309 in the Doppler and 1375 in the fetoscope arms, respectively. Abnormal FHR was detected in 55 (4.2%) vs 42 (3.1%). (RR = 1.38; 95%CI: 0.93, 2.04) in the Doppler and fetoscope arms, respectively. Bag mask ventilation was performed in 80 (6.1%) vs 82 (6.0%). (RR = 1.03; 95%CI: 0.76, 1.38) of neonates, and adverse perinatal outcome was comparable 32(2.4%) vs 35(2.5%). (RR = 0.9; 95%CI: 0.59, 1.54), in the Doppler and fetoscope arms, respectively.
conclusionThis trial failed to demonstrate a statistically significant difference in the detection of abnormal FHR between intermittently used Doppler and fetoscope and adverse perinatal outcomes. However, FHR measurements were not performed as often as recommended by international guidelines. Conducting a randomized controlled study in rural settings with limited resources is associated with major challenges.
trial registrationThis clinical trial was registered on April 2013 with registration number NCT01869582 .
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.