Status:
COMPLETED
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)
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Cervical Ripening
Pregnancy
Eligibility:
FEMALE
Brief 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...
Eligibility Criteria
Inclusion
- Patients who received the PROPESS in treatment for initiation of cervical ripening in patients at term (from 37 completed weeks of gestation). This prospective survey is an observational (non-interventional) survey for re-examination of the safety profile of PROPESS. It only collects data under conditions of use in routine medical practices.
Exclusion
- None
Key Trial Info
Start Date :
February 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT04773314
Start Date
February 28 2021
End Date
June 30 2022
Last Update
April 26 2023
Active Locations (1)
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1
Osaka University Hospital (there may be other sites in this country)
Osaka, Japan, 565-0871