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

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.

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Key information

Conditions

Prelabor Rupture of Membranes Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Latency between the rupture of membranes and the onset of labour

Time frame: At labour onset (up to 6 days)

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.

Secondary outcomes

Trigger rate for prolonged rupture of membranes

Time frame: 48 hours after 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle JADEAU

CONTACT

[email protected]

+33244710204

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: RESIRUPT

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Dec 24, 2025
Registry last updated: Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed