Clinical trial NCT04869280: Post-Marketing Study of Prucalopride Safety In Pregnancy
Official title: Prucalopride (MOTEGRITY®, RESOTRAN®) Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study of Prucalopride Safety in Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Idiopathic Constipation (CIC)
Keywords: Fetal and infant outcomes
Prucalopride
Pregnancy Registry
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: The Organization of Teratology Information Specialists
First posted: 2021-05-03
Enrollment: 616
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Percentage of Participants With Major Structural Defects
timeFrame: Up to 1 year of age
Secondary outcomes:
measure: Number of Participants With Spontaneous Abortion/Miscarriage
timeFrame: 20 weeks post-last menstrual period (LMP)
measure: Number of Participants With Stillbirth
timeFrame: From 20 weeks post-LMP to end of pregnancy
measure: Number of Participants With Elective Termination/Abortion
timeFrame: At the end of pregnancy or through 9-month pregnancy period
measure: Number of Participants With Premature Delivery
timeFrame: Through 9-month pregnancy period
measure: Incidence of Small for Gestational Age
timeFrame: At birth
measure: Number of Participants With Postnatal Growth Deficiency
timeFrame: Up to 1 year of age
measure: Screening for Neurodevelopmental Milestones
timeFrame: 1 year of age
measure: Incidence of Hospitalization in Live Born Children
timeFrame: Up to 1 year of age
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
affiliation: The Organization of Teratology Information Specialists
name: Study Director
role: STUDY_DIRECTOR
References: