A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy

NCT ID: NCT04961840

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-12-31

Brief Summary

This study will collect information on pregnant women diagnosed with constipation from the two large health care insurance claims records.

It will include the following groups:

• Those who took prucalopride.
• Those who took other medicines for constipation.
• Those who did not take any prescription medicines for constipation.

The main aim of the study is to find out whether the medicine prucalopride, which is used to treat constipation, is safe for use during pregnancy and to look at whether taking prucalopride at certain times during pregnancy is associated to a higher chance of specific health problems for the mother or baby.

The study uses two large existing healthcare insurance databases for collecting information. Participants are not enrolled, treated, or required to visit the doctor during this study.

Conditions

Constipation; Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1: Pregnant Women Exposed to Prucalopride

Pregnant women with clinically diagnosis of constipation who have been exposed to prucalopride during pregnancy will be observed.

No Intervention

Intervention Type: OTHER

This is a non-interventional study.

Cohort 2: Pregnant Women Not Exposed to Prucalopride

Pregnant women with clinical diagnosis of constipation who have been exposed to other constipation drugs and not prucalopride during pregnancy will be observed.

No Intervention

Intervention Type: OTHER

This is a non-interventional study.

Cohort 3: Untreated Pregnant Women

Pregnant women with clinical diagnosis of constipation with no recorded prescription dispensed for any constipation drugs during pregnancy will be observed.

No Intervention

Intervention Type: OTHER

This is a non-interventional study.

Interventions

No Intervention

This is a non-interventional study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women aged 18 to 44 years with constipation.
• Maternal coverage by health care and prescriptions insurance during eligibility period:

a) To study pregnancy outcomes (live births, spontaneous abortions, terminations, or stillbirths): 90 days prior to the LMP until end of pregnancy; and b) to study malformations, perinatal and infant outcomes: 90 days to LMP until 30 days post-delivery.

• For infant outcomes, the cohort will be restricted to pregnancies with linked offspring.
• For major malformations, only pregnancies with livebirths will be included, since information regarding the pathological results from a pregnancy loss or the indication for termination is rarely recorded. In addition, infants are required to have full insurance coverage from delivery to at least 90 days after the delivery, unless the infant died prior to the end of the 90 days, in which case a shorter eligibility period until death is permitted.
• For the analyses of pregnancy losses, the cohort also includes pregnancies ending in spontaneous abortion, terminations, stillbirth and any livebirth (linked or unlinked to a delivery).

Exclusion Criteria

• Women with opioids dispensed in the 3 months prior to LMP or during the first trimester (to exclude potential opioid-induced constipation) and women with inflammatory bowel diseases (IBD) (because IBD is a contraindication)
• For major malformations, the cohort excludes pregnancies with a chromosomal abnormality based on at least one inpatient or outpatient ICD-9 code for 758.xx,759.81-759.83, or 655.1x within 90 days after delivery in the infant and/or maternal claims.
• For major malformations, pregnancies with outpatient exposure to definite teratogens including warfarin, valproate, antineoplastic agents, colchicine, testosterone, radioiodine, isotretinoin, misoprostol, and thalidomide from LMP through LMP plus 90 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Harvard T.H. Chan School of Public Health

Boston, Massachusetts, United States

Countries

United States

Related Links

https://clinicaltrials.takeda.com/study-detail/60f18511268b2a001f5a991f

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

Other Identifiers

EUPAS41866

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-555-5002

Identifier Type: -

Identifier Source: org_study_id