Prelabor Rupture of MembranesRESIRUPTNCT07301957
Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins
A study testing Additional rupture of the residual membrane in people with Prelabor Rupture of Membranes, run by Centre Hospitalier le Mans at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prelabor Rupture of Membranes
- What is being tested?
- Additional rupture of the residual membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Mar 2026to 24 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Angers
Angers, 49000
Pierre-Emmanuel BOUET, MD, +33241354215, pierreemmanuel.bouet@chu-angers.fr
Pierre-Emmanuel BOUET, MD
- Recruiting
Centre Hospitalier Le Mans
Le Mans, 72000
Christelle JADEAU, +33244710204, recherchecliniquepromotion@ch-lemans.fr
Marie-Charlotte FAURANT, MD
About this study
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.
Read more
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
- Being tested
- Additional rupture of the residual membrane
- Keywords
- prelabor rupture of membranes
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional rupture of the residual membraneOther
Additional rupture of the residual membrane using a sterile, single-use amniotic membrane piercer such as the Robé device
| Study group | Role | What they receive |
|---|---|---|
| Additional rupture of the residual membrane | Experimental | Rupture of the residual membrane Receives: Other: Additional rupture of the residual membrane |
| Standard of care | No intervention | unbroken residual membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 48 hours after rupture of membranes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start24 Mar 2026
- Primary completion24 Mar 2028 (estimated)
- Study completion24 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prelabor Rupture of MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Charlotte FAURANT, MD, Principal investigator, Centre Hospitalier le Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301957
- Sponsor's protocol ID
- CHM-2023/S30/07
- Acronym
- RESIRUPT
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins
- ClinicalTrials.gov ID
- NCT07301957
- Acronym / sponsor ID
- RESIRUPT / CHM-2023/S30/07
- Conditions
- Prelabor Rupture of Membranes
- Keywords
- prelabor rupture of membranes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 24 Mar 2028 (estimated)
- Study completion
- 24 Mar 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional rupture of the residual membrane | Experimental | Other: Additional rupture of the residual membraneRupture of the residual membrane |
| Standard of care | No intervention | –unbroken residual membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- Minor patient
- patient under guardianship/curatorship,
- multiple pregnancy, pregnancy with foetal death
- non-cephalic presentation
- gestational age less than 37 weeks,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional rupture of the residual membraneAdditional rupture of the residual membrane using a sterile, single-use amniotic membrane piercer such as the Robé device | Other | Additional rupture of the residual membrane |
Primary outcome
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.
1 secondary outcome
Trigger rate for prolonged rupture of membranes
Time frame: 48 hours after rupture of membranes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Charlotte FAURANT, MD principal investigator
Centre Hospitalier le Mans
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional rupture of the residual membrane in people with Prelabor Rupture of Membranes, run by Centre Hospitalier le Mans at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (+33244710204, recherchecliniquepromotion@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency between the rupture of membranes and the onset of labour (time frame: At labour onset (up to 6 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.