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NCT Number: NCT06004544

Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women

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.

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Key information

Conditions

Cardiovascular Diseases in Pregnancy

Sex eligibility

Female

Study type

Observational

Primary location

National Institute of Cardiovascular Diseases (NICVD)

Karachi, Sindh, 75510, Pakistan

Location status: Recruiting

Location contact

Sabha Bhatti, MD

PRINCIPAL_INVESTIGATOR

Shakeela Naz, FCPS

SUB_INVESTIGATOR

Sumyia Gurmani, FCPS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obstetric patients attending routine antenatal visits

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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%)

  2. 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)

Secondary outcomes

  1. Number of participants found to have adverse Maternal outcomes

    Time frame: At the time of delivery

    Maternal Mortality, Cardiogenic shock

  2. Number of participants found to have adverse Fetal outcomes

    Time frame: At the time of delivery

    Infant Mortality, Infant birth weight (kg)

Study contacts

Contact information is provided by the study sponsor or research team.

Sabha Bhatti, MD

CONTACT

[email protected]

+92 335 5554346

Shakeela Naz, FCPS

CONTACT

[email protected]

+92 331 3596502

Sponsors and collaborators

Lead sponsor

National Institute of Cardiovascular Diseases, Pakistan

Other

Collaborators

  • Jinnah Postgraduate Medical Centre

Registry information

Acronym: PRESAP

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 22, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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