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)

Ferring

Status: Completed

Conditions: Cervical Ripening; Pregnancy

Treatments: Other: PROPESS Cohort

Study type: Observational

Funder types: Industry

Identifiers

NCT04773314

000378

Details and patient eligibility

About

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.

Enrollment: 409 patients

Sex: Female

Volunteers: No Healthy Volunteers

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