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

NCT04961840 | Active Not Recruiting FDA Drug

• 2 other identifiers: TAK-555-5002EUPAS41866
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Prucalopride; infant outcomes

Outcome Measures

Primary Outcomes (1)

• Percentage of Infants With Major Congenital Malformations

  A major congenital malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Major malformations will be sorted and grouped according to the International Classification of Diseases 10th Revision (ICD-10). Percentage of infants with major congenital malformations after birth will be reported.

  From delivery up to 90 days post-delivery

Secondary Outcomes (8)

• Percentage of Participants With Spontaneous Abortions

  90 days prior to the Last menstrual period (LMP) until end of pregnancy

• Percentage of Participants With Terminations (Discontinuation of Pregnancy)

  90 days prior to the LMP until end of pregnancy

• Percentage of Participants With Stillbirths

  90 days prior to the LMP until end of pregnancy

• Percentage of Participants With Preterm Delivery

  From Delivery to 30 days post-delivery

• Percentage of Infants With Small for Gestational Age (SGA)

  From Delivery to 30 days post-delivery

Study Arms (3)

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.

Other: No Intervention

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.

Other: No Intervention

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.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

Cohort 1: Pregnant Women Exposed to Prucalopride; Cohort 2: Pregnant Women Not Exposed to Prucalopride; Cohort 3: Untreated Pregnant Women

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Pregnant Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include pregnancy women with constipation including those with constipation predominant irritable bowel syndrome.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Harvard T.H. Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Links

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

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 14, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)