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

NCT07301957 | Not Yet Recruiting

• 1 other identifier: CHM-2023/S30/07
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prelabor Rupture of Membranes

Keywords

prelabor rupture of membranes

Outcome Measures

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.

  At labour onset (up to 6 days)

Secondary Outcomes (1)

• Trigger rate for prolonged rupture of membranes

  48 hours after rupture of membranes

Study Arms (2)

Additional rupture of the residual membrane

EXPERIMENTAL

Rupture of the residual membrane

Other: Additional rupture of the residual membrane

Standard of care

NO INTERVENTION

unbroken residual membrane

Interventions

Additional rupture of the residual membrane OTHER

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

Additional rupture of the residual membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (2)

CHU Angers

Angers, 49000, France

Location

Centre Hospitalier Le Mans

Le Mans, 72000, France

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Marie-Charlotte FAURANT, MD

  Centre Hospitalier le Mans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle JADEAU

CONTACT

+33244710204; recherchecliniquepromotion@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-11

Locations

FR (2)