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Recruiting NCT06004544

Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women

Observational Cardiovascular Diseases in Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases in Pregnancy. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • Number of participants found to have abnormal left ventricular function [Time frame: At the time of screening echocardiogram]
  • Number of participants found to have abnormal heart valve function [Time frame: At the time of screening echocardiogram]
Secondary outcome measures (2)
  • Number of participants found to have adverse Maternal outcomes [Time frame: At the time of delivery]
  • Number of participants found to have adverse Fetal outcomes [Time frame: At the time of delivery]

Eligibility criteria

Inclusion criteria

  • Obstetric patients attending routine antenatal visits

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Pakistan · 1 center
  • National Institute of Cardiovascular Diseases (NICVD) — Karachi

Publications

  • 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 39817089

Identifiers

NCT: NCT06004544 · IRB-33/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗