Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting

NCT02790814 | Completed DMC

• 1 other identifier: Moyo Rural
• Study Type: interventional
• Target: 2,652
• Locations: 1 country
• Sites: 1

Brief Summary

Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized control study, at Haydom Hospital, Tanzania.

Conditions

Fetal Monitoring

Outcome Measures

Primary Outcomes (1)

• Frequency of abnormal fetal heart rate detection

  Up to delivery

Secondary Outcomes (3)

• Mode of delivery: vaginal versus operative

  Up to delivery

• Neonatal outcome: dead versus alive

  Up to 24 hours

• Time from abnormal fetal heart rate detection to delivery in minutes

  Up to delivery

Study Arms (2)

Moyo strap-on

EXPERIMENTAL

Continous fetal heart rate monitoring

Device: Moyo strap-on

Hand-held fetoscope

ACTIVE COMPARATOR

Intermittent fetal heart rate monitoring

Device: Hand-held fetoscope

Interventions

Moyo strap-on DEVICE

Continous measurements

Moyo strap-on

Hand-held fetoscope DEVICE

Intermittent measurements

Hand-held fetoscope

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women admitted in labor

You may not qualify if:

• Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Haydom Lutheran Hospital, Research Institute

Haydom, Manyara Region, 9041, Tanzania

Location

Related Publications (1)

• Mdoe PF, Ersdal HL, Mduma E, Moshiro R, Dalen I, Perlman JM, Kidanto H. Randomized controlled trial of continuous Doppler versus intermittent fetoscope fetal heart rate monitoring in a low-resource setting. Int J Gynaecol Obstet. 2018 Dec;143(3):344-350. doi: 10.1002/ijgo.12648. Epub 2018 Sep 4.

  PMID: 30120775 DERIVED

Study Officials

• Hege L. Ersdal, Md PhD

  Helse Stavanger HF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 6, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)