Echocardiographic Screening of Pregnant Women During Antenatal Care

Pregnancy Complications Clinical Trial

Official title:

Effectiveness of Echocardiographic Screening of Pregnant Women During Antenatal Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936815
• Other study ID #: IRC/2121/021
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: University Hospital Inselspital, Berne
• Contact: Surendra Uranw, MPH
• Phone: 00977 9842042705
• Email: surendra.uranw[@]bpkihs.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Pregnancy Complications
• Rheumatic Heart Disease
• Valvular Heart Disease

Intervention

Diagnostic Test:
• Transthoracic echocardiography
Transthoracic echocardiography for the detection of congenital or acquired structural heart disease.

Locations

Country	Name	City	State
Nepal	B.P. Koirala Institute of Health Sciences	Dharan Bazar
Switzerland	Department of Cardiology, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Pilgrim	B.P. Koirala Institute of Health Sciences

Countries where clinical trial is conducted

Nepal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of fetal/neonatal adverse events	Death; Preterm birth (<37 weeks); Birthweight <2500g	6 weeks after delivery