Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins
Recruiting
N/AInterventional Study
Prelabor Rupture of Membranes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
130 (estimated)
Sponsor
Centre Hospitalier le Mans · Other
Who this trial is looking for
This trial is looking for women over 18 who have had their membranes rupture before labor starts but are not in labor. Participants will be monitored in the hospital to see how long it takes for labor to begin and what affects the timing.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old
I am having a single pregnancy with the baby head down
I have experienced a rupture of membranes without starting labor
I am affiliated with a social security scheme
I have signed consent to participate
You may not be able to join if
I am a minor
I am under guardianship or curatorship
I have a multiple pregnancy or a baby that has died in the womb
The baby is not in a head-down position
I am less than 37 weeks pregnant
My membranes ruptured more than 12 hours ago
I cannot have a vaginal delivery
I have signs of an infection or other complications
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 resid…
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.
Trial Locations
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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 wr…
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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