Premature Rupture of Membranes at TermNCT04565340
Foley vs Propess for Induction of Labor in Women With Term PROM : Mode of Delivery, Maternal and Fetal Outcomes
An observational study of Premature Rupture of Membranes at Term and Mode of Delivery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Premature rupture of membranes at term is a rupture that occurs at term (>37SA) before the start of labor. It complicates 5 to 10% of pregnancies and 6 to 22% of term pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Rupture of Membranes at Term, Mode of Delivery
- What is being tested?
- Mode of delivery, maternal and neonatal outcomes/complications
- How many people
- 188 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 Aug 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with Premature Rupture Of Membranes at term (>37SA) at Montpellier University Hospital
Who may be able to join
- Singleton Pregnancy >37 weeks of gestation
- Premature Rupture Of Membranes
- Cephalic presentation
- Unfavorable cervix (BISHOP <7)
- No contraindication of induction methods
Who cannot join
- Multiple gestation
- PROM with spontaneous labor
- Induction of labor with both methods
- Previous cesarean section
- Unexplained metrorrhagia / Placenta praaevia
- Suspected intraamniotic infection
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- Herpes simplex virus
- Human immunodeficiency virus
- Any contraindication to vaginal delivery
- Latex allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Foley Catheter Versus Prostaglandin E2 (Propess) Inserts for Induction of Labor in Women With Term Premature Rupture Of Membranes : Mode of Delivery and Maternal and Fetal Outcomes
Premature rupture of membranes at term is a rupture that occurs at term (>37SA) before the start of labor. It complicates 5 to 10% of pregnancies and 6 to 22% of term pregnancies.
Althought some studies support efficacy of the Foley catheter for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with premature rupture of membranes at term.
The aim of this retrospective study at the Montpellier University Hospital is to evaluate the effect of the Foley catheter compared to Propess in women with premature rupture of membranes at term, on the induction of labor and the maternal and fetal complications.
- Being tested
- Mode of delivery, maternal and neonatal outcomes/complications
- Keywords
- Complications and outcomes maternal and neonatal, Induction of labor, Prostaglandins, Foley Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mode of delivery, maternal and neonatal outcomes/complicationsOther
Mode of delivery, maternal and neonatal outcomes/complications
| Study group | Role | What they receive |
|---|---|---|
| Induction of labor with Foley catheter | Induction of labor with Foley catheter | |
| Induction of labor with Propess | Induction of labor with Propess Receives: Other: Mode of delivery, maternal and neonatal outcomes/complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
mode of delivery (vaginal delivery or cesarean)
mode of delivery (vaginal delivery or cesarean)
Measured: 1 day
Secondary outcomes (1)
maternal and fetal outcomes
looking for maternal complications (endometritis, chorioamniotitis, transfusion, post-partum hemorrhage) and neonatal complications (sepsis, apgar<7 at 5minutes, pH <7,15, neonatal intensive care unit)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Mar 2020
- Primary completion30 Mar 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of Membranes at TermStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, PUPH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565340
- Sponsor's protocol ID
- RECHMPL20_0143
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley Catheter Versus Prostaglandin E2 (Propess) Inserts for Induction of Labor in Women With Term Premature Rupture Of Membranes : Mode of Delivery and Maternal and Fetal Outcomes
- ClinicalTrials.gov ID
- NCT04565340
- Acronym / sponsor ID
- RECHMPL20_0143
- Keywords
- Complications and outcomes maternal and neonatal, Induction of labor, Prostaglandins, Foley Catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 25 Sep 2020 (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.
Premature rupture of membranes at term is a rupture that occurs at term (>37SA) before the start of labor. It complicates 5 to 10% of pregnancies and 6 to 22% of term pregnancies.
Althought some studies support efficacy of the Foley catheter for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with premature rupture of membranes at term.
The aim of this retrospective study at the Montpellier University Hospital is to evaluate the effect of the Foley catheter compared to Propess in women with premature rupture of membranes at term, on the induction of labor and the maternal and fetal complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction of labor with Foley catheter | – | –Induction of labor with Foley catheter |
| Induction of labor with Propess | – | Other: Mode of delivery, maternal and neonatal outcomes/complicationsInduction of labor with Propess |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Premature Rupture Of Membranes at term (>37SA) at Montpellier University Hospital
Key inclusion criteria (5 listed)
- Singleton Pregnancy >37 weeks of gestation
- Premature Rupture Of Membranes
- Cephalic presentation
- Unfavorable cervix (BISHOP <7)
- No contraindication of induction methods
Key exclusion criteria (10 listed)
- Multiple gestation
- PROM with spontaneous labor
- Induction of labor with both methods
- Previous cesarean section
- Unexplained metrorrhagia / Placenta praaevia
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 |
|---|---|---|
| Mode of delivery, maternal and neonatal outcomes/complicationsMode of delivery, maternal and neonatal outcomes/complications | Other | Induction of labor with Propess |
Primary outcome
mode of delivery (vaginal delivery or cesarean)
Time frame: 1 day
mode of delivery (vaginal delivery or cesarean)
1 secondary outcome
maternal and fetal outcomes
Time frame: 1 day
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 25 Sep 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Premature Rupture of Membranes at Term
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Meconium-stained Amniotic Fluid, Chorioamnionitis
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.
Florent FUCHS, PUPH study director
University Hospital, Montpellier
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 Premature Rupture of Membranes at Term and Mode of Delivery, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 10 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 25 Sep 2020. 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 France. 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?
mode of delivery (vaginal delivery or cesarean) (time frame: 1 day). 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 25 Sep 2020.