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)

NCT04773314 | Completed

• 1 other identifier: 000378
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Ripening; Pregnancy

Outcome Measures

Primary Outcomes (9)

• 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

Interventions

PROPESS Cohort OTHER

Non-intervention

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Osaka University Hospital (there may be other sites in this country)

Osaka, 565-0871, Japan

Location

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 26, 2021
• Study Start: February 28, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

JP (1)