An interventional study of Additional rupture of the residual membrane in Prelabor Rupture of Membranes, sponsored by Centre Hospitalier le Mans. Recruiting at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Other
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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.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's planned enrollment of 130 is below the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rupture of the residual membrane
Other: Additional rupture of the residual membrane
unbroken residual membrane
Additional rupture of the residual membrane using a sterile, single-use amniotic membrane piercer such as the Robé device
Latency between the rupture of membranes and the onset of labour
Latency is evaluated by the time in minutes between the rupture of membranes and the onset of labour. The diagnosis of rupture is the spontaneous loss of fluid through the vagina. The diagnosis of labour is defined by the onset of painful uterine contractions and cervical changes. The time recorded will be when the patient's cervix is 3 cm dilated.
Time frame: At labour onset (up to 6 days)
Trigger rate for prolonged rupture of membranes
Trigger rate for prolonged rupture of membranes was evaluated by absence of spontaneous labour 48 hours after the time H0 defined during the initial consultation (rupture of membrane's diagnosis)
Time frame: 48 hours after rupture of membranes
Started Mar 2026 (actual). Primary completion is estimated for Mar 2028, 24 months after the start.
Of 23 interventional studies with no phase under Fetal Membranes, Premature Rupture, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 62. This study's planned 24 months is below that.
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Fetal Membranes, Premature Rupture →
Centre Hospitalier le Mans