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)

April 25, 2023 updated by: Ferring Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
409

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse drug reactions associated with uterine hypercontractions
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
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
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
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
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
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
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
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
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
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
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
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
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
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
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
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
Time Frame: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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