NCT07301957

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Centre Hospitalier le Mans · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

2 sites across 1 country: France