Post-Marketing Study of Prucalopride Safety In Pregnancy

NCT04869280 | Active Not Recruiting FDA Drug

• 2 other identifiers: TAK-555-5001EUPAS40231
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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)

Keywords

Fetal and infant outcomes; Prucalopride; Pregnancy Registry

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Major Structural Defects

  Major structural defects are defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects. All major structural defects will be adjudicated by the co-investigator on this study.

  Up to 1 year of age

Secondary Outcomes (8)

• Number of Participants With Spontaneous Abortion/Miscarriage

  20 weeks post-last menstrual period (LMP)

• Number of Participants With Stillbirth

  From 20 weeks post-LMP to end of pregnancy

• Number of Participants With Elective Termination/Abortion

  At the end of pregnancy or through 9-month pregnancy period

• Number of Participants With Premature Delivery

  Through 9-month pregnancy period

• Incidence of Small for Gestational Age

  At birth

Study Arms (2)

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.

Other: No Intervention

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.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

Cohort-1: Pregnant Women Exposed to Prucalopride Prior to Enrollment; Cohort-2: Pregnant Women Not Exposed to Prucalopride

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women from the United States (US) and Canada who have or have not been treated with prucalopride for CIC or IBS-C during their pregnancy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead
• The Organization of Teratology Information Specialists: collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related Links

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

• Study Director

  The Organization of Teratology Information Specialists

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 3, 2021
• Study Start: May 21, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)