Randomised Clinical Trial: Modified Intrapartum Maternal Sims Position-related Efficiency in the Correction of Persistent Foetal Occipito-posterior Position
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Rotation
研究概览
简要总结
Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia.
Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio.
The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.
详细描述
Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia.
Background: There is a theoretical basis for the possible effects of maternal positions on foetal positions. Despite all the studies published in recent years, conclusive trials providing significant scientific evidence are lacking.
Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio.
The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •adult pregnant women (>18 years of age)
- •persistent posterior foetal position diagnosed during labour through two vaginal examinations two hours apart.
- •at-term gestations (37 to 42 weeks)
- •women in labour with epidural anaesthesia
排除标准
- •multiple gestations
- •previous severe foetal malformation diagnosed
- •macrosomic foetus diagnosed by ultrasound in the 3rd trimester (> percentile 95), or IUGR (< percentile 10)
- •women with contraindicated vaginal delivery owing to previous vaginal surgeries
- •women with severe heart diseases
- •diabetic pregnant women (types I, II and gestational)
- •hypertension problems during labour
- •myopathies
结局指标
主要结局
Rotation
时间窗: During labour
the foetal head's capacity to rotate 145º clockwise until the minor fontanelle is situated under the pubic bone, expressed as yes or no, depending on whether there is rotation or not.
次要结局
- Delivery mode(The first two hours after delivery)
- rotating to OA(During labour)