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)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2022
  • participants needed
    400
  • sponsor
    Ferring Pharmaceuticals
Updated on 27 April 2021
Investigator
Clinical Development Support
Primary Contact
Osaka University Hospital (there may be other sites in this country) (8.9 mi away) Contact

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.

Details
Condition Labor, Cervical Ripening, Pregnancy, Labor/Delivery
Treatment PROPESS Cohort
Clinical Study IdentifierNCT04773314
SponsorFerring Pharmaceuticals
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

None
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