A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy
Condition(s) studied
Investigational drug(s) / intervention(s)
No Intervention: This is a non-interventional study.
Study 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.
Eligibility
Primary outcome measure(s)
- Percentage of Infants With Major Congenital Malformations — From delivery up to 90 days post-delivery
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Harvard T.H. Chan School of Public Health | Boston | Massachusetts |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04961840 on ClinicalTrials.gov ↗ ← All trials in the USA