Cervical RipeningNCT04773314
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)
An observational study of Cervical Ripening and Pregnancy, run by Ferring Pharmaceuticals at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Ripening, Pregnancy
- What is being tested?
- PROPESS Cohort
- How many people
- 409 participants
- Where
- 1 siteJapan
- Study dates
- 28 Feb 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who received the PROPESS in treatment for initiation of cervical ripening in patients at term (from 37 completed weeks of gestation).
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Japan1 site
Osaka University Hospital (there may be other sites in this country)
Osaka, 565-0871
About this study
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)
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
- Being tested
- PROPESS Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROPESS CohortOther
Non-intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions associated with uterine hypercontractions
Events defined as uterine hypercontractions were uterine hyperstimulation, uterine tachysystole, uterine hypertonus, uterine contractions abnormal.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: From administration of the drug to 24 hours after administration of the drug or 2 hours after birth whichever is longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start28 Feb 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RipeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773314
- Sponsor's protocol ID
- 000378
- Status last verified
- Apr 2023
- First submitted
- 11 Feb 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04773314
- Acronym / sponsor ID
- 000378
- Conditions
- Cervical Ripening, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received the PROPESS in treatment for initiation of cervical ripening in patients at term (from 37 completed weeks of gestation).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROPESS CohortNon-intervention | Other | – |
Primary outcome
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.
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.
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
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.
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
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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Ripening and Pregnancy, run by Ferring Pharmaceuticals at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.