Post-Marketing Study of Prucalopride Safety In Pregnancy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04869280
Study type	Observational
Source	Takeda
Contact	Contact
Phone	+1-877-311-8972
Email	mothertobaby@health.ucsd.edu
Status	Recruiting
Phase
Start date	May 21, 2021
Completion date	May 31, 2026

View Details

See also
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