Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women (PRESAP)

August 27, 2023 updated by: Sabha Bhatti, National Institute of Cardiovascular Diseases, Pakistan
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75510
        • Recruiting
        • National Institute of Cardiovascular Diseases (NICVD)
        • Principal Investigator:
          • Sabha Bhatti, MD
        • Sub-Investigator:
          • Sumyia Gurmani, FCPS
        • Sub-Investigator:
          • Shakeela Naz, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive obstetric patients attending routine antenatal visits

Description

Inclusion Criteria:

  • Obstetric patients attending routine antenatal visits

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants found to have adverse Maternal outcomes
Time Frame: At the time of delivery
Maternal Mortality, Cardiogenic shock
At the time of delivery
Number of participants found to have adverse Fetal outcomes
Time Frame: At the time of delivery
Infant Mortality, Infant birth weight (kg)
At the time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Collaborators

Jinnah Postgraduate Medical Centre

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

August 20, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-33/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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