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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)

Pregnancy Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04773314
Study type Observational
Source Ferring Pharmaceuticals
Contact
Status Completed
Phase
Start date February 28, 2021
Completion date June 30, 2022
View Details
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