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PRESAP: Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women

Sponsor
National Institute of Cardiovascular Diseases, Pakistan (Other)
Overall Status
Recruiting
CT.gov ID
NCT06004544
Collaborator
Jinnah Postgraduate Medical Centre (Other)
10,000
Enrollment
1
Location
70.8
Anticipated Duration (Months)
141.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women
    Actual Study Start Date :
    Feb 6, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2028
    Anticipated Study Completion Date :
    Dec 31, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular diseases in pregnancy [At the time of screening echocardiogram]

      Prevalence of Left ventricular dysfunction (Ejection Fraction<55%)

    2. Cardiovascular diseases in pregnancy [At the time of screening echocardiogram]

      Structural heart abnormalities (valvular lesions classified as mild, moderate and severe)

    Secondary Outcome Measures

    1. Maternal-fetal outcomes [At the time of delivery]

      Maternal and fetal survival, maternal complications at delivery, infant birth weight (kg)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Obstetric patients attending routine antenatal visits
    Exclusion Criteria:
    • Patients refused to give consent for echocardiography or participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institute of Cardiovascular Diseases (NICVD) Karachi Sindh Pakistan 75510

    Sponsors and Collaborators

    • National Institute of Cardiovascular Diseases, Pakistan
    • Jinnah Postgraduate Medical Centre

    Investigators

    • Principal Investigator: Sabha Bhatti, MD, National Institute of Cardiovascular Diseases

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sabha Bhatti, Professor, National Institute of Cardiovascular Diseases, Pakistan
    ClinicalTrials.gov Identifier:
    NCT06004544
    Other Study ID Numbers:
    • IRB-33/2023
    First Posted:
    Aug 22, 2023
    Last Update Posted:
    Aug 28, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Aug 28, 2023