A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy

StatusActive, Not Recruiting
PhaseNot specified
SponsorTakeda
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 31, 2026 → Jun 30, 2027
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Record History

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  1. Primary and study completion pushed from Dec 31, 2026 to Jun 30, 2027
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints: details revised at 5 of 8 entries
  2. Primary and study completion dates: Dec 1, 2025 to Dec 31, 2026
    • Eligibility criteria shortened, about 65 words
    • Secondary endpoints: 5 to 8
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Interventions: No Intervention (Other)v5
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Mar 1, 2026 to Dec 1, 2025
    • Site details revised
    v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  2. Study Identification, Study Status, Referencesv2
  1. Study First Submitted
  • 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.
Takeda
222 trials monitored
See 14 trials at risk
This study will collect information on pregnant women diagnosed with constipation from the two large health care insurance claims records. It will include the following groups: * Those who took prucalopride. * Those who took other medicines for constipation. * Those who did not take any prescription medicines for constipation. The main aim of the study is to find out whether the medicine prucalopride, which is used to treat constipation, is safe for use during pregnancy and to look at whether taking prucalopride at certain times during pregnancy is associated to a higher chance of specific health problems for the mother or baby. The study uses two large existing healthcare insurance databases for collecting information. Participants are not enrolled, treated, or required to visit the doctor during this study.
Trial Details
NCT Number NCT04961840
Lead Sponsor Takeda
Conditions
(from sponsor)		 Constipation, Pregnancy
Related terms Constipation
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov