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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)
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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Osaka University Hospital (there may be other sites in this country)
Osaka, Japan
Start Date
February 28, 2021
Primary Completion Date
June 30, 2022
Completion Date
June 30, 2022
Last Updated
April 26, 2023
409
ACTUAL participants
PROPESS Cohort
OTHER
Lead Sponsor
Ferring Pharmaceuticals
NCT06768060
NCT07462065
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06273683