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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prelabor Rupture of Membranes
• Intervention / Treatment: Other: Additional rupture of the residual membrane

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle JADEAU; Phone Number: +33244710204; Email: recherchecliniquepromotion@ch-lemans.fr

Study Locations

• France
  • Angers, France, 49000
    • CHU Angers
    • Contact: Pierre-Emmanuel BOUET, MD; Phone Number: +33241354215; Email: pierreemmanuel.bouet@chu-angers.fr
    • Principal Investigator: Pierre-Emmanuel BOUET, MD
  • Le Mans, France, 72000
    • Centre Hospitalier Le Mans
    • Contact: Christelle JADEAU; Phone Number: +33244710204; Email: recherchecliniquepromotion@ch-lemans.fr
    • Principal Investigator: Marie-Charlotte FAURANT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Additional rupture of the residual membrane; Rupture of the residual membrane	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
No Intervention: Standard of care; unbroken residual membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	48 hours after rupture of membranes

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Investigators: Principal Investigator: Marie-Charlotte FAURANT, MD, Centre Hospitalier Le Mans

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: prelabor rupture of membranes
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: CHM-2023/S30/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No