NCT04961840

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

Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride During Pregnancy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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

• Constipation
• Pregnancy

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-07-14
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study