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)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Cervical Ripening
• Intervention / Treatment: Other: PROPESS Cohort

• Study Type: Observational
• Enrollment (Actual): 409

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 565-0871
    • Osaka University Hospital (there may be other sites in this country)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse drug reactions associated with uterine hypercontractions	Events defined as uterine hypercontractions were uterine hyperstimulation, uterine tachysystole, uterine hypertonus, uterine contractions abnormal.	From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Incidence of adverse drug reactions associated with foetal distress	Events defined as foetal distress were abnormal labour affecting foetus, foetal heart rate disorder, foetal heart rate deceleration abnormality, bradycardia foetal, foetal heart rate abnormal, foetal heart rate decreased, foetal heart rate increased, tachycardia foetal, foetal acidosis, meconium in amniotic fluid, apgar score low, encephalopathy neonatal, arrhythmia neonatal, baseline foetal heart rate variability disorder, bradycardia neonatal, foetal arrhythmia, nonreassuring foetal heart rate pattern, cyanosis neonatal, infantile apnoea, neonatal anoxia, neonatal asphyxia, neonatal hypoxia, neonatal respiratory depression, foetal distress syndrome, foetal monitoring abnormal, neonatal respiratory distress syndrome, neonatal respiratory distress.	From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Incidence of adverse drug reactions of foetal distress, uterine rupture, cervical laceration and amniotic fluid embolus in patients with uterine hypercontractions		From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Incidence of adverse drug reactions by background factors affecting the occurrence of foetal distress	Adverse drug reactions incidence rate by background factors such as patient age, height, weight, smoking history, medical history, pregnancy related disease, history of surgery on the uterus and cervix, presence or absence of uterine hypercontractions at the time of the previous parturition and concomitant medications, affecting the occurrence of foetal distress will be presented.	From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Incidence of adverse drug reactions		From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Incidence of serious adverse events		From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Incidence of adverse drug reactions by background factors affecting the overall safety of the product	Adverse drug reactions incidence rate by background factors such as patient age, height, weight, smoking history, medical history, history of surgery on the uterus and cervix, presence or absence of uterine hypercontractions at the time of the previous parturition and concomitant medications, affecting the overall safety of the product will be presented.	From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Incidence of adverse drug reactions/adverse events in the foetuses and newborns		From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Percentage of newborns with an Apgar score of less than 7 at 5 minutes after parturition		From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 000378

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No