Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women

Cardiovascular Diseases in Pregnancy Clinical Trial

— PRESAP  

Official title:

Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004544
• Other study ID #: IRB-33/2023
• Status: Recruiting
• Start date: February 6, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2023
• Source: National Institute of Cardiovascular Diseases, Pakistan
• Contact: Sabha Bhatti, MD
• Phone: +92 335 5554346
• Email: drsabhabhatti[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Obstetric patients attending routine antenatal visits

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Diseases in Pregnancy

Locations

Country	Name	City	State
Pakistan	National Institute of Cardiovascular Diseases (NICVD)	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Pakistan	Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants found to have abnormal left ventricular function	Prevalence of Left ventricular dysfunction (Ejection Fraction<55%)	At the time of screening echocardiogram
Primary	Number of participants found to have abnormal heart valve function	Structural heart abnormalities (valvular heart lesions classified as mild, moderate and severe)	At the time of screening echocardiogram
Secondary	Number of participants found to have adverse Maternal outcomes	Maternal Mortality, Cardiogenic shock	At the time of delivery
Secondary	Number of participants found to have adverse Fetal outcomes	Infant Mortality, Infant birth weight (kg)	At the time of delivery