NCT06004544

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Feb 2023Dec 2028

Study Start

First participant enrolled

February 6, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

5.9 years

First QC Date

August 6, 2023

Last Update Submit

August 27, 2023

Conditions

Cardiovascular Diseases in Pregnancy

Outcome Measures

Primary Outcomes (2)

  • Number of participants found to have abnormal left ventricular function

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

    At the time of screening echocardiogram

  • 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 Outcomes (2)

  • Number of participants found to have adverse Maternal outcomes

    At the time of delivery

  • Number of participants found to have adverse Fetal outcomes

    At the time of delivery

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive obstetric patients attending routine antenatal visits

You may qualify if:

  • Obstetric patients attending routine antenatal visits

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiovascular Diseases (NICVD)

Karachi, Sindh, 75510, Pakistan

RECRUITING

Related Publications (1)

  • Bhatti S, Naz S, Gurmani S, Yasmin H, Atif U, Karim M, Ahmed S, Zehra K, Hakeem A, Qamar N. Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women. JACC Adv. 2024 Sep 2;3(12):101215. doi: 10.1016/j.jacadv.2024.101215. eCollection 2024 Dec.

    PMID: 39817089DERIVED

Study Officials

  • Sabha Bhatti, MD

    National Institute of Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabha Bhatti, MD

CONTACT

+92 335 5554346drsabhabhatti@gmail.com

Shakeela Naz, FCPS

CONTACT

+92 331 3596502dr.shakeela7@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 22, 2023

Study Start

February 6, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)