A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 633
- 试验地点
- 1
- 主要终点
- Cesarean section rate (all causes)
研究概览
简要总结
In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour was 21 % and 16% to 38% in case of dystocia.
The definition of " dystocia " is traditionally based on the research led by Friedman in the 1950's on a restricted population sample. Several studies over the last years seem to indicate that the different phases of labour are longer than originally described by Friedman.
Our current hypothesis is that the application of a new definition of dystocia would enable a more appropriate management of labour.
详细描述
The main purpose of this study is to show a significant decrease of the CS rate with the use of the new partograph developed by Neal and Lowe.
Secondary purposes are
- To reduce the use of oxytocin during labour without increasing maternal or neonatal morbidity;
- To decrease immediate per-operative complications and post-operative complications associated with CS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Affiliation to a social security insurance
- •Written consent given
- •Singleton pregnancy
- •Cephalic presentation
- •≥37 gestational weeks
- •Spontaneous onset of labour
排除标准
- •Previous cesarean section
- •Induction of labour
- •Intrauterine growth restriction
- •In utero fetal death
- •Congenital malformation
- •Chorioamnionitis
- •Placenta praevia
- •Need for an emergency delivery (fetal heart rate abnormalities at admission)
- •Contra-indication for vaginal delivery
- •Patient under temporary guardianship, guardianship or judicial protection
- •Patient included in another study which could interfere with the results of this study
研究组 & 干预措施
Classical partograph
Labour dystocia is diagnosed when cervical dilation is less than 1 cm per hour or after 3 hours at complete cervical dilation without engagement of the presentation. In this case, active management of labour is started with introduction of oxytocin, artificial rupture of membranes and supportive therapy.
干预措施: Classical partograph (Other)
New partograph
The second strategy is based on the partograph developped by Neal and Lowe. An active management of labour is started when crossing the dystocia line or when there are no cervical modifications after 4 hours beyond 5 cm of cervical dilation. In this case, active management of labour is started with introduction of oxytocin, artificial rupture of membranes and supportive therapy.
干预措施: New partograph based on the studies of Neal and Lowe (Other)
结局指标
主要结局
Cesarean section rate (all causes)
时间窗: From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)
次要结局
- obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome(From the admission in the labour ward until the dismissal from maternity (2 to 5 days))
- Maternal measures associated with possible effects of both strategies on maternal and fetal outcome(From the admission in the labour ward until the dismissal from maternity (2 to 5 days))
- Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome(From the admission in the labour ward until the dismissal from maternity (2 to 5 days))