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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier le Mans

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Minor patient

patient under guardianship/curatorship,

multiple pregnancy, pregnancy with foetal death

non-cephalic presentation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Additional rupture of the residual membrane

    Other intervention

    Additional rupture of the residual membrane using a sterile, single-use amniotic membrane piercer such as the Robé device

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Additional rupture of the residual membraneExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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