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TAK-555-5001
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Post-Marketing Study of Prucalopride Safety In Pregnancy

Clinicaltrials.gov
#NCT04869280
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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.

US
Observational clinical trial.

At a glance

What medical conditions are being studied?

Chronic Idiopathic Constipation (CIC)

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

Entry criteria

Must be pregnant women with constipation.
Either must have taken prucalopride during this pregnancy at some point within the first 3 months of pregnancy or must not have taken prucalopride at any time during this pregnancy.
Cannot be aware of any major defect in the fetus.
Cannot have been in the study for a previous pregnancy. Note: Women who have had exposure to prucalopride during pregnancy, but who do not meet the eligibility criteria for enrollment into the prucalopride exposed cohort group, will be invited to participate in a separate prucalopride exposure case series.
Pregnancy cannot have ended before starting the study.
Additional entry criteria will be discussed with the study team.

Locations

Recruiting