Echocardiographic Screening of Pregnant Women During Antenatal Care

Not Applicable

Recruiting

• Conditions: Rheumatic Heart Disease; Valvular Heart Disease; Pregnancy Complications
• Interventions: Diagnostic Test: Transthoracic echocardiography

• Registration Number: NCT04936815
• Lead Sponsor: Thomas Pilgrim

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).

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 Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Study Start: 2021-12-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 9000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Echocardiographic screening	Transthoracic echocardiography	Echocardiographic screening for the detection of latent structural heart disease

Primary Outcome Measures

Name	Time	Method
Composite endpoint	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 Outcome Measures

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

Trial Locations

Locations (2)

Department of Cardiology, Bern University Hospital; 🇨🇭 Bern, Switzerland

B.P. Koirala Institute of Health Sciences; 🇳🇵 Dharān Bāzār, Nepal