Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04936815

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

B.P. Koirala Institute of Health Sciences, Dharān, Nepal

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transthoracic echocardiography

Diagnostic Test

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

Primary outcomes

  1. Composite endpoint

    Time frame: 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).

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

Secondary outcomes

  1. Incidence of maternal adverse events

    Time frame: 6 weeks after delivery

    Death; Cerebrovascular Events; Heart failure; Cardiac interventions; Supraventricular tachycardia, Atrial fibrillation, Ventricular tachycardia; Thrombotic and thromboembolic events; Postpartum haemorrhage.

  2. Incidence of fetal/neonatal adverse events

    Time frame: 6 weeks after delivery

    Death; Preterm birth (<37 weeks); Birthweight <2500g

Sponsors and collaborators

Lead sponsor

Thomas Pilgrim

Other

Collaborators

  • B.P. Koirala Institute of Health Sciences

Registry information

Official study title

Effectiveness of Echocardiographic Screening of Pregnant Women During Antenatal Care

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Jun 23, 2021
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.