The Labour Progression Study, a Cluster Randomised Trial on Labour Progression for First Time Mothers
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 6,582
- 试验地点
- 1
- 主要终点
- Rate of emergency caesarean section
研究概览
简要总结
The purpose of this study is to evaluate if the rate of emergency caesarean section can be reduced if adhering to a dynamic labour progression curve compared to a static progression curve for first time mothers without jeopardising maternal and neonatal outcomes
详细描述
- Introduction The increasing rate of emergency caesarean sections in developed countries is of great concern as it is associated with adverse outcomes for mother and infant. The rate of caesarean sections for first time mothers with a singleton foetus in a vertex position and spontaneous onset of labour at term has increased from 5.7 % to 9.2 % in Norway. The most common indication for emergency caesarean sections is Labour dystocia, even if there is no consensus on criteria for the diagnosis.
Labour dystocia is characterised by abnormally slow progress of labour and is among the most common challenges of birth care especially in first time mothers. When the labour progression is assessed to be prolonged according to current guidelines, labour dystocia is treated by amniotomy followed by oxytocin infusion to augment uterus contractions. Oxytocin is a potent drug and classified by the Institute for Safe Medication Practices in the USA as one of 12 medications which is "bearing heightened risk of harm".
In Norway the guidelines for expected progression of labour is based on modifications of Friedman's curve of cervical dilatation, a linear labour progression curve developed in 1953. Contemporary research by Zhang shows that the dilatation of the cervix can be substantially slower than earlier expected, especially at an early stage of labour.
Hypothesis: By adhering to the guideline for labour progression presented by Zhang, the rate of emergency caesarean sections in first time mothers will decrease compared to adhering to the guideline for labour progression based on a modified Friedman's curve, without jeopardising the maternal and neonatal outcomes. 2. Background and status of knowledge Traditionally the labour process is divided in two stages; the first stage and the second stage. The first stage is divided in two phases; the latent phase and the active phase, the latent phase is defined from onset of labour until the cervix is dilated four centimetres with 3-4 painful contractions per ten minutes. The active phase is defined from a cervix dilatation of four centimetres until fully dilated. The second stage is divided in two phases; the deceleration phase where the baby's head is decelerating towards the pelvic floor and the expulsion phase where the mother is actively pushing the baby out.
To visualize the progression of labour, the status of the cervix dilatation is traditionally measured and recorded throughout labour on a graphic curve often called a partogram. The partogram is widely used internationally and facilitates that midwives' and doctors' can monitor labour progression, and together with criteria for labour dystocia, consequently carry out necessary interventions.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 析因
- 主要目的
- 其他
- 盲法
- 开放(无盲法)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- Robson group I:First time mothers with a singleton foetus in a vertex position, in spontaneous onset of labour between gestational week 37-42
排除标准
- Robson groups 2-10
研究组 & 干预措施
Static labour progression curve (F)
Guideline with the following expected labour progression: if the cervix dilates at least 1 centimetre per hour assessed after 4 hours. Labour dystocia is diagnosed if progression proceeds slower than this definition throughout the active phase of the first stage of labour. Labour dystocia in the second stage of labour is diagnosed if lasting longer than two hours, three hours for women with epidurals or if the expulsion phase lasts longer than 60 minutes.
干预措施: Static labour progression curve (F) (Other)
Dynamic progression curve (Z)
Guideline which takes into account the dilatation of the cervix on admission and calculates the expected progression during the active phase of the first stage of labour based on this finding. Labour dystocia in the second stage of labour is diagnosed if lasting longer than two hours and 45 minutes, three hours and 30 minutes for women with epidurals or if the expulsion phase lasts longer than 60 minutes.
干预措施: Dynamic progression curve (Other)
结局指标
主要结局
Rate of emergency caesarean section
时间窗: 14 months
次要结局
- The use of oxytocin for augmenting uterus contractions(14 months)
研究者
Stine Bernitz
Midwife, PhD
Ostfold Hospital Trust
研究点 (1)
标识符
- NCT 编号
- NCT02221427
- 其他研究编号
- LAPS3293
日期
- 首次提交
- (12年前)
- 首次发布
- (12年前)
- 主要完成日期
- (9年前)
- 研究完成日期
- (10个月前)
- 最近核实
- (2年前)
- 最近更新
- (2年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否
