NCT07301957 Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins
| NCT ID | NCT07301957 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier le Mans |
| Condition | Prelabor Rupture of Membranes |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2028-03-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2026-03-24 with a primary completion date of 2028-03-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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-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.
Eligibility Criteria
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
Contact & Investigator
Marie-Charlotte FAURANT, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier le Mans
Frequently Asked Questions
Who can join the NCT07301957 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Prelabor Rupture of Membranes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07301957 currently recruiting?
Yes, NCT07301957 is actively recruiting participants. Contact the research team at recherchecliniquepromotion@ch-lemans.fr for enrollment information.
Where is the NCT07301957 trial being conducted?
This trial is being conducted at Angers, France, Le Mans, France.
Who is sponsoring the NCT07301957 clinical trial?
NCT07301957 is sponsored by Centre Hospitalier le Mans. The principal investigator is Marie-Charlotte FAURANT, MD at Centre Hospitalier le Mans. The trial plans to enroll 130 participants.