Post-Marketing Study of Prucalopride Safety In Pregnancy
About this clinical trial
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.
At a glance
What medical conditions are being studied?
What is the clinical trial testing?
No Intervention
How many participants are being enrolled?
616
Are placebos part of the clinical trial?
No
When is the clinical trial being conducted?
May 2021 - May 2026
How long is participation in the clinical trial?
Each participant will be in the study during pregnancy and up to 1 year after their baby is born. The study is open to participants across the United States and Canada.
Key requirements
Sexes
Female
Age
All
Healthy volunteers?
No