National Prospective and Comparative Study on the Mode of Delivery of Twins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,979
- 试验地点
- 1
- 主要终点
- Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation
研究概览
简要总结
The purpose of this study is to determine the best obstetrical practices for twin delivery.
详细描述
Large retrospective cohort studies have reported increased neonatal death and morbidity associated with vaginal delivery in comparison with cesarean in twin pregnancies. A recent large international randomized trial, the Twin Birth Study (TBS), showed that planned cesarean does not significantly decrease or increase the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery in twin pregnancy between 32 and 39 weeks of gestation with a first twin in cephalic presentation. However, neither these large retrospective cohort studies, because information regarding delivery management is lacking, nor the TBS, because of insufficient statistical power, can answer the question on how to manage vaginal twin deliveries.
The aim of the JUMODA study is first to confirm in France whether planned vaginal delivery is not associated with increased neonatal risks in comparison with planned caesarean as shown in the TBS and secondly to determine the best obstetrical practices in case of vaginal delivery.
Analysis will be performed according to the planned mode of delivery (planned cesarean or planned vaginal delivery) and stratified according to:
- Twin rank: second or first twin
- Gestational age: before 28 weeks of gestation, before 32 weeks, after 32 weeks, and after 35 weeks
- In the whole population and in low risk populations.
For women delivering vaginally, analysis will be stratified according to: 4. Second twin presentation: vertex or non vertex 5. Obstetrical manoeuvres: none, internal cephalic version, external cephalic version, total breech extraction
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients delivering twins after 22 weeks and 0 days gestation in the participating maternities will be included in the study.
排除标准
- •Patients who expressed opposition to the use of personal medical data or medical data from their children for this research will not be included in the study
结局指标
主要结局
Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation
时间窗: 72 hours after birth
* Intrapartum fetal death * Neonatal mortality * Apgar score lower than 4 at 5 minutes * Neonatal trauma (fracture of long bones or skull, subdural hematoma, brachial plexus elongation, phrenic or facial paralysis, injury of the spinal cord * Abnormal level of consciousness (coma, stupor, abnormal response to pain) * Intubation longer than 24 hours within the first 72 hours of life, two or more episodes of neonatal convulsions in the first 72 hours of life * Proved neonatal infection * Bronchopulmonary dysplasia * Necrotizing enterocolitis * Intraventricular hemorrhage grade III or IV * Periventricular leukomalacia.
次要结局
- Composite measure of intrapartum and neonatal death and serious morbidity of the first twin after 32 weeks 0 days of gestation(Day 28 after birth)
- Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation(Day 28 after birth)
- Composite measure of maternal death and serious morbidity after 32 weeks 0 days of gestation(Weeks after birth and before hospital discharge)
- Duration of neonatal hospitalisation of first twin(Weeks after birth and before hospital discharge)
- Duration of neonatal hospitalisation of second twin(Weeks after birth and before hospital discharge)
- Duration of maternal hospitalisation(Weeks after birth and before hospital discharge)