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N/A N=1,987 Randomized Diagnostic

Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda

Stillbirth · Neonatal Death

Enrolled (actual)
1,987
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Stillbirth and Neonatal Death — 6; 11 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Fetal heart rate Doppler (Device); Partograph (Procedure)
Age
Pediatric, Adult, Older Adult
Sex
Female
Sponsor
The Hospital for Sick Children
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Stillbirth and Neonatal Death
6; 11
PRIMARY
Quality of Partograms
SECONDARY
Identification of Abnormal Fetal Heart Rate
46; 75
SECONDARY
Cesarean Delivery (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted Delivery)
61; 89; 166; 175

Summary

A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital setting in Uganda. The investigators propose that with its ease of use, both for the woman and midwife, midwives using the Doppler will identify more babies in need of prompt delivery and the risk of stillbirth and neonatal mortality will decline. In the research study, the investigators will compare the risk of stillbirths and neonatal mortality in two randomized groups of labouring women. The second part of the study consists of an audit of the documentation in labour by midwives. The partograph is an uncomplicated, low cost form on which observations during labour are documented. It includes three sections of information: fetal condition, maternal condition and labour progress. Although the use of a partograph during labour is strongly recommended by the WHO, there are limited published systematic evaluations of the correct use of the tool. The investigators aim to use this randomized trial design to assess rates of intrapartum stillbirth and neonatal mortality in the first 24 hours after delivery, and assess the quality of partographs comparing two groups. This trial will provide insights on the potential benefits of using handheld Doppler devices for intrapartum monitoring, and the audit of partograph quality will provide insights to improve care during labour. This study hypothesizes that the quality of partograph completion and of fetal heart rate monitoring may systematically differ between the Doppler and Pinard groups.

Eligibility Criteria

Inclusion Criteria

  • All mothers presenting to the labour wards in labour with a singleton pregnancy above 37 completed weeks of gestation, and cephalic presentation
  • All mothers admitted to the labour ward for monitoring of active phase of labour with a live intrauterine fetus

Exclusion Criteria

  • Mothers admitted to the labour wards with a pregnancy gestation age below 37 weeks
  • Mothers admitted with a diagnosis of intra uterine fetal death
  • Mothers presenting in second stage of labour
  • Mothers with a high risk pregnancy eg pre eclampsia, ante partum hemorrhage
  • Mothers being admitted for an elective caesarean section
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02273037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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