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RecruitingNCT06004544PRESAPUpdated Aug 30, 2023

Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women

An observational study in Cardiovascular Diseases in Pregnancy, sponsored by National Institute of Cardiovascular Diseases, Pakistan. Recruiting at 1 site in Pakistan. Open to female participants. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by National Institute of Cardiovascular Diseases, Pakistan · Observational

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases in Pregnancy
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Institute of Cardiovascular Diseases, Pakistan is the lead sponsor of 22 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive obstetric patients attending routine antenatal visits

Inclusion criteria

  • Obstetric patients attending routine antenatal visits

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Number of participants found to have abnormal left ventricular function

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

    Time frame: At the time of screening echocardiogram

  2. Number of participants found to have abnormal heart valve function

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

    Time frame: At the time of screening echocardiogram

Secondary outcomes

  1. Number of participants found to have adverse Maternal outcomes

    Maternal Mortality, Cardiogenic shock

    Time frame: At the time of delivery

  2. Number of participants found to have adverse Fetal outcomes

    Infant Mortality, Infant birth weight (kg)

    Time frame: At the time of delivery

07

Study locations

1 of 1 sites recruiting
  • National Institute of Cardiovascular Diseases (NICVD)
    Karachi, Sindh 75510, Pakistan
    • Sabha Bhatti, MD · Principal investigator
    • Sumyia Gurmani, FCPS · Sub investigator
    • Shakeela Naz, FCPS · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06004544
Lead sponsor
National Institute of Cardiovascular Diseases, Pakistan
Collaborators
Jinnah Postgraduate Medical Centre
Responsible party
Sabha Bhatti (Professor, National Institute of Cardiovascular Diseases, Pakistan) — Principal investigator
First posted
Aug 22, 2023
Start date
Feb 6, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 30, 2023

Study contacts

Sabha Bhatti, MD
Contact
drsabhabhatti@gmail.com
+92 335 5554346
Shakeela Naz, FCPS
Contact
dr.shakeela7@gmail.com
+92 331 3596502
Sabha Bhatti, MD
principal investigator · National Institute of Cardiovascular Diseases

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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