Echocardiographic Screening of Pregnant Women During Antenatal Care

Effectiveness of Echocardiographic Screening of Pregnant Women During Antenatal Care

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Complications; Rheumatic Heart Disease; Valvular Heart Disease
• Intervention / Treatment: Diagnostic test: Transthoracic echocardiography

Detailed Description

Latent structural heart disease may result in complications during pregnancy and delivery. Echocardiographic screening of pregnant women allows for timely detection of structural heart disease in women that may complicate delivery and jeopardize the health and well-being of both the mother and the newborn. In a setting of high rates of latent rheumatic heart disease, with particular high prevalence among women, systematic echocardiographic screening may be a pragmatic approach to prevent adverse clinical outcome related to valvular heart failure. Systematic echocardiographic screening proved to be effective among children in endemic regions.

The present study is a registry-based, adaptive cluster randomized crossover trial. The trial will be nested into a registry of pregnant women presenting for routine antenatal care. The experimental condition will be echocardiographic screening. The control condition will be no echocardiographic screening.

In the experimental condition, all pregnant women presenting for routine antenatal care will be offered transthoracic echocardiographic screening for the detection of latent structural heart disease. In the control condition, pregnant women will undergo routine antenatal care with echocardiography only when clinically indicated. Ascertainment of the primary endpoint will be performed at hospital discharge after delivery and will rely on routinely collected data. All events will be independently adjudicated by an expert panel of pediatricians, cardiologists and gynecologists.

The randomization relates solely to the detection of rheumatic heart disease, while treatment follows guideline recommendations. It is important to note, that all women both in the experimental arm and the control arm detected to have heart disease will undergo optimal medical management during pregnancy and delivery according to the most recent guidelines.

• Study Type: Interventional
• Enrollment (Estimated): 9000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Dharān, Nepal, 56700
    • B.P. Koirala Institute of Health Sciences
• Switzerland
  • Bern, Switzerland, 3010
    • Department of Cardiology, Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Echocardiographic screening; Echocardiographic screening for the detection of latent structural heart disease	Diagnostic test: Transthoracic echocardiography; Transthoracic echocardiography for the detection of congenital or acquired structural heart disease.
No Intervention: Control arm; Routine antenatal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of maternal adverse events	Death; Cerebrovascular Events; Heart failure; Cardiac interventions; Supraventricular tachycardia, Atrial fibrillation, Ventricular tachycardia; Thrombotic and thromboembolic events; Postpartum haemorrhage.	6 weeks after delivery
Incidence of fetal/neonatal adverse events	Death; Preterm birth (<37 weeks); Birthweight <2500g	6 weeks after delivery

Collaborators and Investigators

• Sponsor: Thomas Pilgrim
• Collaborators: B.P. Koirala Institute of Health Sciences
• Investigators: Principal Investigator: Thomas Pilgrim, MD, MSc, Department of Cardiology, Bern University Hospital, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): November 30, 2024
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Rheumatic Fever; Pregnancy Complications; Heart Valve Diseases; Rheumatic Heart Disease; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: IRC/2121/021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No