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Post-Marketing Study of Prucalopride Safety In Pregnancy

NCT04869280 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2025-08-13

No results posted yet for this study

Summary

This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride. The main aim of the study is to learn if any medical problems in pregnant women or their infants might be related to taking prucalopride during pregnancy.

Participants are not required to take prucalopride during the study. The study is non-interventional. Women and their infants are followed during pregnancy and for 1 year after pregnancy to collect information on maternal, pregnancy, and infant outcomes.

During the study, participants will be asked questions during 3 telephone interviews; 2 during pregnancy and 1 just after their expected delivery date. Participants who took or are taking prucalopride will be asked more detailed questions about this during these interviews. All information is collected remotely, and no visits to the study site are required.

Also, all participants will be asked to complete a questionnaire about their baby when their baby is about 1 year old.

Conditions

  • Chronic Idiopathic Constipation (CIC)

Interventions

OTHER

No Intervention

This is a non-interventional study.

Sponsors & Collaborators

  • The Organization of Teratology Information Specialists

    collaborator OTHER

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

  • Study Director · The Organization of Teratology Information Specialists

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2027-02-01
Completion
2027-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04869280 on ClinicalTrials.gov