NCT04869280

Post-Marketing Study of Prucalopride Safety In Pregnancy

Prucalopride (MOTEGRITY®, RESOTRAN®) Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study of Prucalopride Safety in Pregnancy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Idiopathic Constipation (CIC)

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2021-05-21
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2021-05-03
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study