NCT04773314

General Drug Use-results Survey on PROPESS Vaginal Inserts in Treatment for Initiation of Cervical Ripening in Patients at Term (From 37 Completed Weeks of Gestation)

General Drug Use-results Survey on PROPESS® Vaginal Inserts 10 mg in Treatment for Initiation of Cervical Ripening in Patients at Term (From 37 Completed Weeks of Gestation)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 409 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

To confirm and consider the occurrence of important identified risks described in the Japanese Pharmaceutical Risk Management Plan (J-RMP) under conditions used in routine medical practice. The safety specification include: uterine hypercontractions and associated foetal distress, uterine rupture, cervical laceration, amniotic fluid embolism, and foetal distress.

Conditions

• Cervical Ripening
• Pregnancy

Interventions

Type	Name	Description
OTHER	PROPESS Cohort	Non-intervention

Timeline

• Start date: 2021-02-28
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-02-26
• Last updated: 2023-04-26

Locations

1 site across 1 country: Japan