Echocardiographic Screening of Pregnant Women During Antenatal Care

NCT04936815 | Active Not Recruiting

• 1 other identifier: IRC/2121/021
• Study Type: interventional
• Target: 9,000
• Locations: 2 countries
• Sites: 2

Brief 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; Pregnancy Complications; Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Composite endpoint

  Incidence rate of the composite of maternal death, fetal/neonatal death, maternal heart failure, maternal hospitalization for cardiovascular reasons or an APGAR Score \<7.

  For APGAR Score: 10 minutes after birth. For all other components of the composite endpoint: Hospital discharge after delivery (on an average of 4 days after delivery) or 7 days after delivery (whatever takes first).

Secondary Outcomes (2)

• Incidence of maternal adverse events

  6 weeks after delivery

• Incidence of fetal/neonatal adverse events

  6 weeks after delivery

Study Arms (2)

Echocardiographic screening

EXPERIMENTAL

Echocardiographic screening for the detection of latent structural heart disease

Diagnostic Test: Transthoracic echocardiography

Control arm

NO INTERVENTION

Routine antenatal care

Interventions

Transthoracic echocardiography DIAGNOSTIC_TEST

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

Echocardiographic screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women ≥18 years presenting for routine antenatal care.
• Written informed consent.

You may not qualify if:

• Women presenting to the hospital after delivery.
• Women presenting directly for delivery without previous antenatal care.

Sponsors & Collaborators

• Thomas Pilgrim: lead
• B.P. Koirala Institute of Health Sciences: collaborator

Study Sites (2)

B.P. Koirala Institute of Health Sciences

Dharān, 56700, Nepal

Location

Department of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Heart Valve Diseases; Rheumatic Heart Disease; Pregnancy Complications

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Thomas Pilgrim, MD, MSc

  Department of Cardiology, Bern University Hospital, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Physician-in-Chief

Model Details: Three clusters representing the three administrative units of the Ob/Gyn department will be randomly allocated to an experimental or a control condition. During 18 months, each of the three clusters will undergo a randomly allocated experimental period of 6 months and two control periods of 6 months. Women seen at least once during the experimental period will be offered to undergo systematic echocardiographic screening for structural heart disease followed by guideline-directed peripartum management. Women only seen during the control periods will undergo routine antenatal care and receive echocardiography only if clinically indicated. After 15 months recruitment, the investigators will perform a conditional power analysis. If the conditional power is below 80% but above 50%, and an extension is considered feasible, the investigators will extend the recruitment duration to 36 months and allocate each administrative unit to another experimental recruitment period of 6 months duration.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: December 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: March 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); NE (1)