Induction of Labour With Dinoprostone vs. Expectant Management After Prelabour Rupture of Membranes at Term
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 主要终点
- Time from randomisation to delivery
研究概览
简要总结
Prelabour rupture of membranes (PROM) is associated with intrauterine infection and maternal and neonatal consequences. This risk increases with the length of time from PROM to delivery. Induction of labor has been shown to reduce the rates of those complications, however the optimal time interval has not yet been determined.
The main purpose of this single-center randomized prospective study is to assess the differences between two approaches of managing PROM at term-expectant management and induction with a dinoprostone vaginal delivery system.
详细描述
Women with singleton pregnancy in cephalic presentation at term (37-41 6/7 weeks gestational age) will be randomised 4 to 12 hours after PROM when a sterile vaginal exam will be completed to assign Bishop score. When Bishop score at presentation will be ≤5, the study will be presented to the patient. Once the patient will be consented and randomized, women will receive dinoprostone vaginal delivery system (for up to 24 hours after randomisation) or will be managed expectantly (for up to 24 hours after randomisation).
Patients randomized to the expectant management group will be admitted to the maternity ward, where they will wait up to a maximum of 24 hours for labor to start spontaneously.
Patients in the induction group will also be admitted to the maternity ward and induced with a dinoprostone vaginal delivery system. If not removed sooner, the vaginal delivery system will be removed after 24h.
If patients in both groups will not be in active labor 24 hours after randomisation they will be admitted to the delivery room and health care providers will manage active labor per usual practice. The need for cesarean section or operative delivery or will be at the discretion of the healthcare provider.
In the days following birth, woman in both groups, will be asked to fill in a questionnaire about their satisfaction with the labour experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •4 to12 hours after prelabour rupture of membranes
- •18-50 years of age
- •Parity 0 to 2
- •Singleton pregnancy
- •Cephalic presentation
- •Term (37-41 6/7 weeks gestational age)
- •Bishop score ≤5
- •Reassuring fetal status
排除标准
- •Uterine contractions
- •Signs of infection
- •Signs of non-reassuring fetal status
- •Meconium-stained amniotic fluid
- •Group B Streptococcus colonization
- •Fetal demise or major congenital anomaly
- •Intrauterine growth restriction (estimated fetal weight ≤ 3 percentile)
- •Contraindications for vaginal birth or use of prostaglandins for labor induction
研究组 & 干预措施
Dinoprostone
Participants will receive dinoprostone 10 mg vaginal delivery system for up to 24 hours.
干预措施: Dinoprostone (Drug)
结局指标
主要结局
Time from randomisation to delivery
时间窗: Within 1 week
Time measured from randomisation to the delivery time
次要结局
- Time from randomisation to spontaneous vaginal delivery(Within 1 week)
- Time from PROM to delivery(Within 1 week)
- Rate of chorioamnionitis(Within 1 week)
- Cesarean delivery rate(Within 1 week)
- Use of oxytocin(Within 1 week)
- Lenght of antibiotic treatment(3 weeks)
- Patients perception of labor (length, pain, overall satisfaction)(Within 3 weeks)
- Instrumental delivery rate(Within 1 week)
- Rate of postpartum maternal fever(Within 3 weeks)
- Maternal Length of Stay(Within 3 weeks)
- Hyperstimulation with nonreassuring fetal heart rate tracing(Within 1 week)
- Use of antibiotics(Within 3 weeks)
- Number of neonates, admitted to intensive care unit(Within 3 weeks)
- Rate of endometritis(Within 3 weeks)
- APGAR scores(Within 1 week)
- Rate of early neonatal sepsis(Within 3 weeks)
研究者
Polona Peclin
Principal investigator
University Medical Centre Ljubljana