Post-Marketing Study of Prucalopride Safety In Pregnancy

NCT ID: NCT04869280

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2027-02-01

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort-1: Pregnant Women Exposed to Prucalopride Prior to Enrollment

Pregnant women diagnosed with chronic idiopathic constipation (CIC) or irritable bowel syndrome-constipation (IBS-C) who have been exposed to prucalopride during pregnancy and prior to enrollment will be observed.

No Intervention

Intervention Type: OTHER

This is a non-interventional study.

Cohort-2: Pregnant Women Not Exposed to Prucalopride

Pregnant women diagnosed with CIC or IBS-C who have not been exposed to prucalopride will be observed.

No Intervention

Intervention Type: OTHER

This is a non-interventional study.

Interventions

No Intervention

This is a non-interventional study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Cohort 1: Prucalopride-Exposed (MOTEGRITY, RESOTRAN) Cohort:

• Pregnant women.
• Exposure to MOTEGRITY or RESOTRAN (generic forms of prucalopride not allowed) for the treatment of chronic idiopathic constipation (CIC) or irritable bowel syndrome-constipation (IBS-C), for any number of days, at any dose, and at any time from the 1st day of the LMP up to and including the 12th week after the first day of the LMP. If the date of LMP is unclear, or if a first-trimester ultrasound has been done and the estimated date of conception is more than one week discrepant from the menstrual period calculation, the first-trimester ultrasound-derived date will be used to calculate a date for LMP and conception.
• Agree to the conditions and requirements of the study including the interview schedule, and release of medical records.

Cohort 2: Disease-Matched Comparison Cohort:

• Pregnant women.
• Diagnosed with CIC or IBS-C; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible.
• Agree to the conditions and requirements of the study including the interview schedule, and release of medical records.

Exclusion Criteria

Cohort 1: Prucalopride-Exposed (MOTEGRITY, RESOTRAN) Cohort

• Women who have first contact with the project after prenatal diagnosis of any major structural defect.
• Women who have enrolled in the prucalopride cohort study with a previous pregnancy (women may only enroll once in the Prucalopride Pregnancy Cohort Study).
• Women who have used prucalopride for an indication other than CIC or IBS-C.
• Women who do not have exposure in the first trimester of pregnancy.
• Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment).
• Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.

Cohort 2: Disease-Matched Comparison Cohort:

• Women who have first contact with the project after prenatal diagnosis of any major structural defect.
• Exposure to prucalopride (brand name or generic) anytime during the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy.
• Women who have enrolled in the prucalopride cohort study with a previous pregnancy (women may only enroll once in the Prucalopride Pregnancy Cohort Study).
• Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment).
• Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Organization of Teratology Information Specialists

OTHER

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Study Director

Role: STUDY_DIRECTOR

The Organization of Teratology Information Specialists

Locations

University of California San Diego

La Jolla, California, United States

Countries

United States

Related Links

https://clinicaltrials.takeda.com/study-detail/6091a2c8688ad8001f42fbc2

To obtain more information on the study, click here/on this link

Other Identifiers

EUPAS40231

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-555-5001

Identifier Type: -

Identifier Source: org_study_id