Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women

Recruiting

• Conditions: Cardiovascular Diseases in Pregnancy

• Registration Number: NCT06004544
• Lead Sponsor: National Institute of Cardiovascular Diseases, Pakistan

Brief Summary

Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed. Ejection fraction (EF) was quantified using biplane Simpson's method.

Detailed Description

Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed, including parasternal long and short, apical 4- and 2-chamber views. Continuous wave and pulse wave Doppler were used to assess left ventricular outflow tract (LVOT) gradients. Left ventricular (LV) function was quantified using biplane Simpson's method and visually assessed by two independent readers. Patients with significant valve disease or congenital heart disease underwent complete TTE. Those diagnosed with LV dysfunction or other cardiovascular diseases (CVD) were referred to the Cardio-Obstetrics clinic for further management and long-term follow-up.

Study Timeline

• Study Start: 2023-02-06
• Status Verified: 2023-08
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-20
• Study First Posted: 2023-08-22
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-30
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

• Obstetric patients attending routine antenatal visits

Exclusion Criteria

• Patients refused to give consent for echocardiography or participation in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants found to have abnormal left ventricular function	At the time of screening echocardiogram	Prevalence of Left ventricular dysfunction (Ejection Fraction\<55%)
Number of participants found to have abnormal heart valve function	At the time of screening echocardiogram	Structural heart abnormalities (valvular heart lesions classified as mild, moderate and severe)

Secondary Outcome Measures

Name	Time	Method
Number of participants found to have adverse Fetal outcomes	At the time of delivery	Infant Mortality, Infant birth weight (kg)
Number of participants found to have adverse Maternal outcomes	At the time of delivery	Maternal Mortality, Cardiogenic shock

Trial Locations

Locations (1)

National Institute of Cardiovascular Diseases (NICVD); 🇵🇰 Karachi, Sindh, Pakistan