Clinical trial NCT04773314: 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)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Ripening
Pregnancy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 409
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received the PROPESS in treatment for initiation of cervical ripening in patients at term (from 37 completed weeks of gestation).

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 specification include: uterine hypercontractions and associated foetal distress, uterine rupture, cervical laceration, amniotic fluid embolism, and foetal distress.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse drug reactions associated with uterine hypercontractions
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
measure: Incidence of adverse drug reactions associated with foetal distress
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
measure: Incidence of adverse drug reactions of foetal distress, uterine rupture, cervical laceration and amniotic fluid embolus in patients with uterine hypercontractions
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
measure: Incidence of adverse drug reactions by background factors affecting the occurrence of foetal distress
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
measure: Incidence of adverse drug reactions
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
measure: Incidence of serious adverse events
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
measure: Incidence of adverse drug reactions by background factors affecting the overall safety of the product
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
measure: Incidence of adverse drug reactions/adverse events in the foetuses and newborns
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
measure: Percentage of newborns with an Apgar score of less than 7 at 5 minutes after parturition
timeFrame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka University Hospital (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: