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Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins

RecruitingNAAges 18 Years - anyFemaleCentre Hospitalier le Mans
NCT07301957 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Approximately 25% of patients experience premature rupture of membranes before labour. Of these patients, 82% will give birth within 24 hours and 97% within 48 hours. 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-foeta

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women over 18 years of age * 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: * Minor patient * 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
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What it tests

  • Additional rupture of the residual membrane
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Where

2 sites
CHU Angers
Angers, France
Centre Hospitalier Le Mans
Le Mans, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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