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

NCT02273037 | Completed Results

• 1 other identifier: 1000031587
• Study Type: interventional
• Target: 1,987
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Stillbirth; Neonatal Death

Keywords

Labour; Birth asphyxia; Fetal Heart Rate Monitor; Doppler Fetal Heart Rate Monitor; Pinard Horn; Pediatrics; Uganda

Outcome Measures

Primary Outcomes (2)

• Stillbirth and Neonatal Death

  Compare the incidence of fresh stillbirth and neonatal death (within 24h of age) in the Pinard group (current practice) and the Doppler group (study intervention).

  0-24hour of delivery

• Quality of Partograms

  To assess the quality of partographs using a standardized scoring system to audit overall completion and quality, and fetal heart rate monitoring specifically. The investigators will compare the audit results between partographs in the Pinard and Doppler group.

  in labour

Secondary Outcomes (2)

• Identification of Abnormal Fetal Heart Rate

  In labour

• Cesarean Delivery (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted Delivery)

  Birth

Study Arms (2)

Pinard horn

PLACEBO COMPARATOR

Pinard horn (current practice) used to monitor the fetal heart rate in labour in this arm of the study.

Procedure: Partograph

Fetal heart rate Doppler

EXPERIMENTAL

Doppler used to monitor the fetal heart rate in labour in this arm of the study.

Device: Fetal heart rate Doppler; Procedure: Partograph

Interventions

Fetal heart rate Doppler DEVICE

A wind-up, handheld fetal heart rate monitor Doppler developed by Power-free Education Technology Doppler (www.pet.org.za)

Also known as: wind-up, handheld Doppler, fetal heart rate monitor, Power-free Education Technology Doppler (www.pet.org.za)

Fetal heart rate Doppler

Partograph PROCEDURE

Graphical documentation of labour progress, and maternal and fetal well-being.

Also known as: Partogram

Fetal heart rate Doppler; Pinard horn

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Nsambya Hospital

Kampala, Uganda

Location

MeSH Terms

Conditions

Stillbirth; Perinatal Death; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Diego G. Bassani
• Organization: The Hospital for Sick Children

diego.bassani@sickkids.ca

+14168137654

Study Officials

• Diego Bassani, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: October 23, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 23, 2018
• Results First Posted: August 23, 2018

Record last verified: 2018-08

Locations

CA (1); UG (1)