Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Latency between the rupture of membranes and the onset of labour
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Additional rupture of the residual membrane
Rupture of the residual membrane
干预措施: Additional rupture of the residual membrane (Other)
Standard of care
unbroken residual membrane
结局指标
主要结局
Latency between the rupture of membranes and the onset of labour
时间窗: 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.
次要结局
- Trigger rate for prolonged rupture of membranes(48 hours after rupture of membranes)