Post-Marketing Study of Prucalopride Safety In Pregnancy

Inclusion Criteria:

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

• Pregnant women.

• Exposure to MOTEGRITY or RESOTRAN (generic forms of prucalopride not allowed) forthe treatment of chronic idiopathic constipation (CIC) or irritable bowelsyndrome-constipation (IBS-C), for any number of days, at any dose, and at any timefrom the 1st day of the LMP up to and including the 12th week after the first day ofthe LMP. If the date of LMP is unclear, or if a first-trimester ultrasound has beendone and the estimated date of conception is more than one week discrepant from themenstrual period calculation, the first-trimester ultrasound-derived date will beused to calculate a date for LMP and conception.

• Agree to the conditions and requirements of the study including the interviewschedule, 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 diseaseindication, with the indication validated by medical records when possible.

• Agree to the conditions and requirements of the study including the interviewschedule, 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 majorstructural 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 pregnancyhas ended prior to enrollment).

• Results of a diagnostic test are positive for a major structural defect prior toenrollment. However, women who have had any normal or abnormal prenatal screening ordiagnostic test prior to enrollment are eligible as long as the test result does notindicate a major structural defect.

Cohort 2: Disease-Matched Comparison Cohort:

• Women who have first contact with the project after prenatal diagnosis of any majorstructural defect.

• Exposure to prucalopride (brand name or generic) anytime during the currentpregnancy; may or may not have taken another medication for their disease in thecurrent 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 pregnancyhas ended prior to enrollment).

• Results of a diagnostic test are positive for a major structural defect prior toenrollment. However, women who have had any normal or abnormal prenatal screening ordiagnostic test prior to enrollment are eligible as long as the test result does notindicate a major structural defect.