Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Duration of labour
研究概览
简要总结
The aim of this observational study is to assess the effect of early labour analgesia on obstetric and neonatal outcomes in induced labour in primiparous women with a full-term pregnancy whose labour was induced with a Cook balloon or prostaglandins.
It aims to answer whether early labour analgesia (< 4 centimetres of cervical dilation) prolongs the duration of labour. Secondary outcomes will be Incidence of caesarean section, use of oxytocin, onset of fetal heart rate abnormalities within 30 minutes of augmentation, incidence of episiotomy, amount of blood loss, need for epidural catheter repositioning due to inadequate analgesia, onset of breakthrough pain defined as need for "rescue" top-ups within 60 minutes of previous top-ups, Apgar score (at 1 and 5 minutes), neonatal umbilical pH and neonatal intensive care unit admission. Patients who received early partoanalgesia were compared for the proposed outcomes with patients who received partoanalgesia in active labour (cervical dilation > 4 centimetres).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •Primipara;
- •Single pregnancy;
- •Gestational age > 36 weeks;
- •Induced labour with Bishop Score < 6;
- •Cervical dilatation at start of analgesia ≤ 6 cm;
- •ASA Class 2.
排除标准
- •Endouterine fetal death;
- •Anhydramnios:
- •Trial labour after caesarean section;
- •Cardiotocogram class ≥2 before start of analgesia;
- •Third trimester bleeding;
- •Patient refusal;
- •Inability to understand informed consent.
结局指标
主要结局
Duration of labour
时间窗: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
The primary objective is to compare the duration of the first stage of labour (measured in minutes) between women who received early neuraxial analgesia in the latent phase of the first stage and those who received it in the active stage. First stage duration is the time elapsed from the onset of labour, as diagnosed by an experienced obstetrician, until 10 centimetres of cervical dilation is reached. The co-primary objective is to compare the duration of the second stage (measured in minutes) between the two populations. Second stage duration is the time from 10 centimetres of cervical dilation to birth. Data on these outcomes are recorded by the obstetric team in the patient's chart during labour.
次要结局
- Admission to neonatal intensive care unit(Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Incidence of operative deliveries(Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Incidence of Episiotomy(Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Incidence of caesarean section during labour(Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Incidence of Obstetric lacerations(Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Oxytocin consumption(Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Peridural catheter repositioning(Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Fetal heart rate abnormalities(Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Apgar score(Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- pH Neonatal umbilical cord(Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
- Administering a 'rescue' epidural analgesia(Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.)
研究者
Silvia Poma
Medical doctor- Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia