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Echocardiographic Screening of Pregnant Women During Antenatal Care

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2024 to Mar 31, 2026
    • Site details revised at 2 of 2 sites
    v5
  2. Primary completion date: May 31, 2023 to Nov 30, 2024
    • Study completion date: Nov 30, 2023 to Dec 31, 2024
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v3
  4. Start date: Oct 1, 2021 to Dec 1, 2021v2 Show 8 more changesShow less
    • Primary endpoints: 2 to 1
    • Enrollment target: 6090 to 9000
    • Primary completion date: Sep 30, 2023 to May 31, 2023
    • Study completion date: Jan 31, 2024 to Nov 30, 2023
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 264 words
    • Study title shortened, about 7 words
    • Eligibility criteria shortened, about 4 words
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings. Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).
Trial Details
NCT Number NCT04936815
Lead Sponsor Thomas Pilgrim
Collaborators: B.P. Koirala Institute of Health Sciences
Conditions
(from sponsor)		 Valvular Heart Disease, Rheumatic Heart Disease, Pregnancy Complications
Related terms Heart Valve Diseases, Pregnancy Complications, Rheumatic Heart Disease
Enrollment 9,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov