Safety of Prucalopride in Pregnant Women
Prucalopride (MOTEGRITY®, RESOTRAN®) Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study of Prucalopride Safety in Pregnancy
This study looks at whether taking prucalopride for chronic constipation during pregnancy affects the health of mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 616 (estimated) |
| Sex | Female |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04869280 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on pregnant women experiencing chronic idiopathic constipation (CIC) who have taken prucalopride, as well as those who have not. The aim is to assess any potential medical issues in mothers or their infants that may be associated with prucalopride use during pregnancy. Participants will undergo three telephone interviews to gather information on maternal and infant outcomes, with follow-up extending for one year post-pregnancy. The study is non-interventional, meaning no specific treatments are administered as part of the research.
Who should consider this trial
Good fit: Ideal candidates include pregnant women who have either taken prucalopride for CIC or IBS-C or those diagnosed with these conditions but have not taken the medication.
Not a fit: Patients who are not pregnant or those who do not have chronic idiopathic constipation or irritable bowel syndrome with constipation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of prucalopride during pregnancy, potentially guiding treatment options for pregnant women with CIC.
How similar studies have performed: While this study focuses on a specific medication in pregnancy, similar observational studies have successfully provided safety data for other medications, suggesting a potential for valuable findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California
- University of California San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Study coordinator: Contact
- Email: mothertobaby@health.ucsd.edu
- Phone: +1-877-311-8972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.