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Echocardiographic Screening of Pregnant Women During Antenatal Care

NCT04936815 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9000

Last updated 2026-01-20

No results posted yet for this study

Summary

Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings.

Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).

Conditions

  • Valvular Heart Disease
  • Rheumatic Heart Disease
  • Pregnancy Complications

Interventions

DIAGNOSTIC_TEST

Transthoracic echocardiography

Transthoracic echocardiography for the detection of congenital or acquired structural heart disease.

Sponsors & Collaborators

  • B.P. Koirala Institute of Health Sciences

    collaborator OTHER

  • Thomas Pilgrim

    lead OTHER

Principal Investigators

  • Thomas Pilgrim, MD, MSc · Department of Cardiology, Bern University Hospital, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-11-30
Completion
2026-03-31

Countries

  • Nepal
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936815 on ClinicalTrials.gov