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NCT04961840 · ClinicalTrials.gov registry record
A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy
A clinical trial of Pregnancy and Constipation, sponsored by Takeda.
- Active
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT04961840: Active study of Pregnancy and Constipation, sponsored by Takeda.
NCT04961840 is a study of Pregnancy and Constipation that is active but no longer recruiting, run by Takeda. The registered enrollment target is 100 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04961840, a study of Pregnancy and Constipation, is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
A major congenital malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Major malformations will be sorted and grouped according to the International Classification of Diseases 10th Revision (ICD-10). Percentage of infants with major congenital malformations after birth will be reported.
Conditions Studied
Interventions
- OTHER No Intervention
Study Locations (1)
Massachusetts
- Harvard T.H. Chan School of Public Health - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2026-12-31 |
What the registry record for NCT04961840 still lists
NCT04961840 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which No Intervention is the first listed.
NCT04961840 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04961840 about?
NCT04961840 is a clinical study titled "A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy". 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 prescripti...
What is the current status of trial NCT04961840?
This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2022-01-01. Estimated completion is 2026-12-31.
What conditions does trial NCT04961840 study?
This clinical trial studies the following conditions: Pregnancy, Constipation.
What interventions are being tested in trial NCT04961840?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT04961840?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04961840 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04961840's enrollment target sits among peer trials
100 117th of 191 higher than 72 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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