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临床试验/NCT06987591
NCT06987591已完成不适用

Impact of Low-Dose Epidural Analgesia on Labour Progression in Robson Class 1 Women: a Retrospective Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 5,995 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,995
试验地点
1
主要终点
Cervical dilation curve

研究概览

简要总结

Aim of the study was to analyse data on cervical dilation and fetal descent patterns in low-risk women, who did or did not receive intermittent low-dose epidural analgesia (EA), and who had either a vaginal or a caesarean delivery.

Therefore, we conducted a retrospective analysis, retrieving data from October 1st 2008 to October 31st 2018. We selected 6030 women categorized as Robson Group 1, divided into four groups according to the mode of delivery (vaginal or caesarean) and the presence of EA:

  • Vaginal delivery with EA (VD-e)
  • Vaginal delivery without EA (VD-n)
  • Caesarean delivery with EA (CD-e)
  • Caesarean delivery without EA (CD-n)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Robson class 1 (nulliparous, single, cephalic full-term pregnancy with spontaneous labour)
  • •maternal age between 18 and 40 years
  • •neonatal weight between 2500 and 4000 grams
  • •cervical dilation <7 cm at admission in the delivery suite

排除标准

  • •minimal duration of labour < 3 hours (from admission to the delivery suite to delivery)

结局指标

主要结局

Cervical dilation curve

时间窗: First stage of labour (from admission to the delivery suite to full cervical dilation)

We modeled the cervical dilation curve using a high-degree mixed polynomial regression. The analysis was conducted separately in women with vaginal or caesarean delivery. The time of complete cervical dilation or caesarean delivery was considered the point 0 for cervical dilation, while the preceding events resulted in negative time compared to the 0.

Fetal head descent curve

时间窗: From admission to the delivery room up to the time of delivery (either via vaginal route or caesarean section)

We modeled the fetal head descent curve using a mixed polynomial regression. The analysis was conducted separately in women with vaginal or caesarean delivery. The time of station +3 (i.e. vaginal birth) or caesarean delivery was considered the point 0 , while the preceding events resulted in negative time compared to the 0.

次要结局

  • Type of vaginal delivery(At delivery)
  • Episiotomy(At delivery.)
  • Maternal complications during vaginal delivery(At delivery.)
  • Fetal indicators(After delivery)
  • Length of active phase(Up to 24 hours from admission.)
  • Length of second stage(Up to 24 hours from admission.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ZANFINI BRUNO ANTONIO

MD

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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