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

NCT04961840 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-12-02

No results posted yet for this 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.

Conditions

Interventions

OTHER

No Intervention

This is a non-interventional study.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04961840 on ClinicalTrials.gov