Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional rupture of the residual membrane.
- Who it may be relevant to
- Registry conditions: Prelabor Rupture of Membranes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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
Primary outcome measures
- Latency between the rupture of membranes and the onset of labour [Time frame: At labour onset (up to 6 days)]
Secondary outcome measures (1)
- Trigger rate for prolonged rupture of membranes [Time frame: 48 hours after rupture of membranes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- CHU Angers — Angers
- Centre Hospitalier Le Mans — Le Mans
Identifiers
NCT: NCT07301957 · CHM-2023/S30/07