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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional rupture of the residual membrane | Experimental | Rupture of the residual membrane |
|
| Standard of care | No Intervention | unbroken residual membrane |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christelle JADEAU | Contact | +33244710204 | recherchecliniquepromotion@ch-lemans.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Charlotte FAURANT, MD | Centre Hospitalier le Mans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Recruiting | Angers | 49000 | France |
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| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Centre Hospitalier Le Mans | Recruiting | Le Mans | 72000 | France |
|