跳至主要内容
临床试验/NCT02486822
NCT02486822Unknown不适用

The Management of Spontaneous Labour in Primigravida (SLiP): Labor Scale Versus WHO Partograph

Assiut University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)

研究概览

简要总结

This study aims to compare the novel labour scale with the traditional WHO partograph in the management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes

详细描述

After many centuries through which vaginal delivery (VD) had been the only safe route of birth, Cesarean section (CS) emerged as an alternative in emergency situations. CS has gradually become an appealing option for both the mother and the obstetrician and its indications increase while CS was proving safety; the rate of CS in U.S.A increased by about 50% within 10 years around the beginning of the current century. However, the increasing prevalence of CS raises questions about the impact of this trend on maternal morbidity, mortality as well as its economic burden. Accordingly, recent guidelines have been directed to revise practice-base CS indications to only situations when CS is truly beneficial to the mother and/or the fetus.

Of these indications, the most reported one was labour dystocia. The WHO partograph is a famous chart that is commonly used to observe uncomplicated labour and is almost an objective approach to guide interference. Unfortunately, the rule of the partograph in reducing the incidence of CS is questionable. Furthermore, the design of the partograph is not exactly perfect to present the process of labour. For these reasons, the labour scale was designed as a novel follow-up chart during labour. The chart considered more objective and timed management of labour with more flexible range of time based on recent evidence. A previous pilot study on 77 women suggested that the labour scale may be a good alternative to the current partograph. This study is the first randomized trial the compares the 2 charts as regards the rate of CS, maternal and neonatal health outcomes and both patient and obstetrician satisfaction.

In this clinical trial, the investigators aim to compare the labour scale to the traditional WHO partograph in terms of incidence of labor dystocia and CS as well as maternal and neonatal outcomes

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 (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primigravida
  • 38 - 42 weeks of gestation
  • Singleton pregnancy
  • Vertex presentation
  • Spontaneous labour
  • Average estimated fetal weight (2500 - 3800 gram)

排除标准

  • Maternal medical or surgical major co-morbidity
  • Previous uterine scar
  • Induction of labor
  • Premature rupture of membranes

研究组 & 干预措施

Labor scale

Experimental

Observation Amniotomy Oxytocin Cesarean Section (CS)

干预措施: Amniotomy (Procedure)

Labor scale

Experimental

Observation Amniotomy Oxytocin Cesarean Section (CS)

干预措施: Oxytocin (Drug)

Labor scale

Experimental

Observation Amniotomy Oxytocin Cesarean Section (CS)

干预措施: Cesarean Section (Procedure)

WHO partograph

Active Comparator

Observation Amniotomy Oxytocin Cesarean Section (CS)

干预措施: Amniotomy (Procedure)

WHO partograph

Active Comparator

Observation Amniotomy Oxytocin Cesarean Section (CS)

干预措施: Oxytocin (Drug)

WHO partograph

Active Comparator

Observation Amniotomy Oxytocin Cesarean Section (CS)

干预措施: Cesarean Section (Procedure)

结局指标

主要结局

Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)

时间窗: Time of labor (maximum 24 hours)

The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia

次要结局

  • Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)(Time of labor (maximum 24 hours))
  • Intrapartum maternal birth injuries (assessed clinically at the time of labor, the extent and type of repair and subsequent complications will be reported)(Time of labour and hospital stay (expected average 72 hours))
  • Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions(The length of hospital stay (expected average 72 hours))
  • Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture(The length of hospital stay (expected average 72 hours))
  • Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring(Duration of labor (maximum 24 hours))
  • birth injuries of the newborn (as reported by physical examination, documentation of birth injuries, and subsequent management )(The length of hospital stay (expected average 1 week))
  • Neonatal distress "asphyxia" (as reported 1 & 5 minutes APGAR score, resuscitation event, umbilical artery pH, admission to NICU, length of stay and any further medical complications)(The length of hospital/NICU stay (expected average 1 week))

研究者

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

Sherif Abdelkarim Mohammed Shazly

M.B.B.Ch, M.S.c

Assiut University

研究点 (1)

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