Moyo; strap-on Fetal Heart Rate Monitoring in an Urban Setting

NCT02790554 | Completed DMC

• 1 other identifier: Moyo Urban
• Study Type: interventional
• Target: 2,973
• 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 Doppler in detection of abnormal fetal heart rate, through a randomized control study, at the University hospital, Dar es Salaam, 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

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

  Up to delivery

• Neonatal outcome dead versus alive

  Up to 24 hours

Study Arms (2)

Moyo strap-on

EXPERIMENTAL

Continous fetal heart rate monitoring

Device: Moyo strap-on

Hand-held Doppler

ACTIVE COMPARATOR

Intermittent fetal heart rate monitoring

Device: Hand-held Doppler

Interventions

Moyo strap-on DEVICE

Continous monitoring

Moyo strap-on

Hand-held Doppler DEVICE

Intermittent monitoring

Hand-held Doppler

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)

Muhimbili National Hospital

Dar es Salaam, 65439, Tanzania

Location

Related Publications (1)

• Kamala B, Kidanto H, Dalen I, Ngarina M, Abeid M, Perlman J, Ersdal H. Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania. Int J Environ Res Public Health. 2019 Jan 24;16(3):315. doi: 10.3390/ijerph16030315.

  PMID: 30678354 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: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)