Post-Marketing Study of Prucalopride Safety In Pregnancy

Prucalopride (MOTEGRITY®, RESOTRAN®) Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study of Prucalopride Safety in Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Constipation
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 616

Contacts and Locations

• Study Contact: Name: Contact; Phone Number: +1-877-311-8972; Email: mothertobaby@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
      • Principal Investigator: Christina Chambers, PhD, MPH
      • Contact: Site Contact; Phone Number: 858-246-1704; Email: chchambers@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: No Intervention; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Spontaneous Abortion/Miscarriage	Spontaneous abortion/miscarriage is defined as non-deliberate fetal death that occurs prior to 20 weeks post-LMP.	20 weeks post-last menstrual period (LMP)
Number of Participants With Stillbirth	Stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 20 weeks post-LMP.	From 20 weeks post-LMP to end of pregnancy
Screening for Neurodevelopmental Milestones	Screening for neurodevelopment performed using the Ages and Stages Questionnaire (ASQ). An abnormal score is defined in the scoring guidelines.	1 year of age
Incidence of Hospitalization in Live Born Children	Hospitalizations is defined as any hospitalization of the infant within the first year of life after discharge following delivery.	Up to 1 year of age
Number of Participants With Elective Termination/Abortion	Elective termination/abortion is defined as deliberate termination of pregnancy through medication or surgical procedures. Elective abortions are classified for medical or social reasons.	At the end of pregnancy or through 9-month pregnancy period
Number of Participants With Premature Delivery	Premature delivery is defined as live birth prior to 37 weeks gestation as counted from LMP (or calculated from first-trimester ultrasound-derived due date if LMP uncertain or more than 1 week discrepant). Elective caesarian deliveries or inductions prior to 37 completed weeks will be considered separately.	Through 9-month pregnancy period
Incidence of Small for Gestational Age	Small for gestational age is defined as birth size (weight, length or head circumference) less than the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants.	At birth
Number of Participants With Postnatal Growth Deficiency	Postnatal growth deficiency is defined as postnatal size (weight, length or head circumference) less than the 10th centile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age.	Up to 1 year of age

Collaborators and Investigators

• Sponsor: Takeda
• Collaborators: The Organization of Teratology Information Specialists
• Investigators: Study Director: Study Director, The Organization of Teratology Information Specialists; Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy Registry; Prucalopride; Fetal and infant outcomes
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: TAK-555-5001; EUPAS40231 (Other Identifier: EU PAS Register Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No