MedDataX Logo

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

NCT ID: NCT02790554

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2973 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fetal Monitoring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Moyo strap-on

Continous fetal heart rate monitoring

Group Type EXPERIMENTAL

Moyo strap-on

Intervention Type DEVICE

Continous monitoring

Hand-held Doppler

Intermittent fetal heart rate monitoring

Group Type ACTIVE_COMPARATOR

Hand-held Doppler

Intervention Type DEVICE

Intermittent monitoring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Moyo strap-on

Continous monitoring

Intervention Type DEVICE

Hand-held Doppler

Intermittent monitoring

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women admitted in labor

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hege L. Ersdal, Md PhD

Role: STUDY_DIRECTOR

Helse Stavanger HF

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Muhimbili National Hospital

Dar es Salaam, , Tanzania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Tanzania

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30678354 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Moyo Urban

Identifier Type: -

Identifier Source: org_study_id