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

Centre Hospitalier le Mans

Status

Not yet enrolling

Conditions

Prelabor Rupture of Membranes

Treatments

Other: Additional rupture of the residual membrane

Study type

Interventional

Funder types

Other

Identifiers

NCT07301957

CHM-2023/S30/07

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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