Trial Outcomes & Findings for Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda (NCT NCT02273037)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1987 participants

Primary outcome timeframe

0-24hour of delivery

Results posted on

2018-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Pinard Pinard Auscultation (standard of care)	Doppler Doppler Auscultation (Intervention)
Overall Study STARTED	987	1000
Overall Study COMPLETED	979	992
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Pinard Pinard Auscultation (standard of care)	Doppler Doppler Auscultation (Intervention)
Overall Study Lost to Follow-up	1	0
Overall Study Delivered before monitoring initiated	1	3
Overall Study Breech delivery	2	3
Overall Study Multiple delivery	2	2
Overall Study Other complication	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pinard n=979 Participants Pinard	Doppler n=992 Participants Doppler	Total n=1971 Participants Total of all reporting groups
Age, Continuous	26 years n=979 Participants	27 years n=992 Participants	27 years n=1971 Participants
Sex: Female, Male Female	979 Participants n=979 Participants	992 Participants n=992 Participants	1971 Participants n=1971 Participants
Sex: Female, Male Male	0 Participants n=979 Participants	0 Participants n=992 Participants	0 Participants n=1971 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Uganda	979 participants n=979 Participants	992 participants n=992 Participants	1971 participants n=1971 Participants

PRIMARY outcome

Timeframe: 0-24hour of delivery

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).

Outcome measures

Outcome measures
Measure	Pinard Horn n=979 Participants Pinard horn (current practice) used to monitor the fetal heart rate in labour in this arm of the study. Partograph: Graphical documentation of labour progress, and maternal and fetal well-being.	Fetal Heart Rate Doppler n=992 Participants Doppler used to monitor the fetal heart rate in labour in this arm of the study. Fetal heart rate Doppler: A wind-up, handheld fetal heart rate monitor Doppler developed by Power-free Education Technology Doppler (www.pet.org.za) Partograph: Graphical documentation of labour progress, and maternal and fetal well-being.
Stillbirth and Neonatal Death	6 Participants	11 Participants

PRIMARY outcome

Timeframe: in labour

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In labour

Compare the incidence of identification of abnormal fetal heart rate in labour in the Pinard and Doppler group.

Outcome measures

Outcome measures
Measure	Pinard Horn n=979 Participants Pinard horn (current practice) used to monitor the fetal heart rate in labour in this arm of the study. Partograph: Graphical documentation of labour progress, and maternal and fetal well-being.	Fetal Heart Rate Doppler n=992 Participants Doppler used to monitor the fetal heart rate in labour in this arm of the study. Fetal heart rate Doppler: A wind-up, handheld fetal heart rate monitor Doppler developed by Power-free Education Technology Doppler (www.pet.org.za) Partograph: Graphical documentation of labour progress, and maternal and fetal well-being.
Identification of Abnormal Fetal Heart Rate	46 Participants	75 Participants

SECONDARY outcome

Timeframe: Birth

Compare the proportion of cesarean delivery between the Pinard and Doppler group. (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted delivery)

Outcome measures

Outcome measures
Measure	Pinard Horn n=979 Participants Pinard horn (current practice) used to monitor the fetal heart rate in labour in this arm of the study. Partograph: Graphical documentation of labour progress, and maternal and fetal well-being.	Fetal Heart Rate Doppler n=992 Participants Doppler used to monitor the fetal heart rate in labour in this arm of the study. Fetal heart rate Doppler: A wind-up, handheld fetal heart rate monitor Doppler developed by Power-free Education Technology Doppler (www.pet.org.za) Partograph: Graphical documentation of labour progress, and maternal and fetal well-being.
Cesarean Delivery (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted Delivery) Cesarean Delivery following abnormality detection	61 Participants	89 Participants
Cesarean Delivery (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted Delivery) Cesarean Delivery	166 Participants	175 Participants

Adverse Events

Pinard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Doppler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Diego G. Bassani

The Hospital for Sick Children

Phone: +14168137654

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place