Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins
NCT ID: NCT07301957
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
130 participants
INTERVENTIONAL
2025-12-01
2027-12-01
Brief Summary
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Patients who do not go into labour spontaneously will be induced 24 or 48 hours after their membranes rupture, depending on the centre.
During this period, they are hospitalised in the obstetrics department. The presence of a residual membrane appears to prolong the latency period before labour begins and the rate of induction, according to a pilot study conducted by investigator.
No study specifically addresses this topic. The various studies on "Rupture of Membranes Before Labour" assess its frequency of occurrence or the time before considering induction. They also assess the occurrence of maternal-foetal infection. This is no longer of interest today, as antibiotic prophylaxis has significantly reduced maternal-foetal infections.
Investigator would therefore like to assess the impact of additional rupture of the residual membrane upon the patient's admission on the latency before labour and the induction rate (for membrane rupture exceeding 48 hours.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Additional rupture of the residual membrane
Rupture of the residual membrane
Additional rupture of the residual membrane
Additional rupture of the residual membrane using a sterile, single-use amniotic membrane piercer such as the Robé device
Standard of care
unbroken residual membrane
No interventions assigned to this group
Interventions
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Additional rupture of the residual membrane
Additional rupture of the residual membrane using a sterile, single-use amniotic membrane piercer such as the Robé device
Eligibility Criteria
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Inclusion Criteria
* Single foetal pregnancy, cephalic presentation
* diagnosis of membrane rupture with persistence of one membrane and absence of immediate spontaneous labour.
* Person affiliated with or beneficiary of a social security scheme
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
Exclusion Criteria
* patient under guardianship/curatorship,
* multiple pregnancy, pregnancy with foetal death
* non-cephalic presentation
* gestational age less than 37 weeks,
* rupture of membranes more than 12 hours ago
* contraindication to vaginal deliver
* meconium-stained amniotic fluid,
* clinical signs suggestive of intrauterine infection (maternal hyperthermia \>38°C, maternal and/or foetal tachycardia, purulent amniotic fluid),
* cervix not accessible for artificial rupture
* vaginismus
* contraindication to a potential expectant management
* indication for induction for another reason
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier le Mans
OTHER
Responsible Party
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Principal Investigators
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Marie-Charlotte FAURANT, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier le Mans
Locations
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CHU Angers
Angers, , France
Centre Hospitalier Le Mans
Le Mans, , France
Countries
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Central Contacts
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Facility Contacts
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Pierre-Emmanuel BOUET, MD
Role: primary
Christelle JADEAU
Role: primary
Other Identifiers
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CHM-2023/S30/07
Identifier Type: -
Identifier Source: org_study_id