跳至主要内容
临床试验/NCT05341076
NCT05341076Unknown不适用

Labor Scale Versus WHO Partograph for Management of Spontaneous Labor in Primigravidae (ScaLP): A Randomized Controlled Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
206
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

The current study aims at evaluating the impact of the implementation of the labor scale, in comparison to the standard WHO partograph, in the management of primiparous women, including CD rate, maternal and neonatal outcomes of labor.

详细描述

Since the procedure was first introduced to clinical practice, Cesarean delivery (CD) has significantly contributed to peripartum maternal and fetal safety when appropriately indicated. Nevertheless, CD rate has significantly increased over the last two decades without parallel improvement in maternal or neonatal outcomes. Globally, one out of three pregnancies would be delivered by CD, resulting in growing surgical, obstetric and financial burden. Over years, long-term sequelae of current CD rate have become evident such as increased incidence of placenta accreta spectrum and exponential rise in CD trend, since 90% of women who had CD are susceptible to CD in future pregnancies. These concerns have triggered a global act to control CD rates within the margins of safe obstetric practice.

The most common indication of CD is labor dystocia. However, the definition of labor dystocia is inconsistent, and standardization of diagnosis has been heavily investigated. The WHO partograph was established at the end of the last century to serve as a tool to recognize labor dystocia and has been universally accepted to verify CD decision However, a cochrane review by Lavender et al. revealed that role of WHO partograph, in improving clinical outcomes, is lacking. In addition, there is no evidence that any published modification of the current partograph is superior to another. The "labor scale," a novel alternative to the classic partograph, was first introduced to literature in 2014. The tool was designed based on evidence-based guidelines and integrates both diagnosis and interventions to manage labor dystocia. Initial data showed that labor scale contributed to decreased incidence of CD and oxytocin administration. However, further studies are required to verify these results.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

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: Duration of labor (maximum 24 hours from onset of labor)

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

次要结局

  • Primary postpartum hemorrhage(Within 24 hours of delivery)
  • Intrapartum fetal distress(Duration of labor (maximum 24 hours))
  • Birth injuries of the newborn(The length of neonatal hospital stay (anticipated duration: 72 hours))
  • Maternal fever/postpartum infections(Within 24 hours of delivery)
  • Intrapartum maternal birth injuries(Duration of labour and hospital stay (anticipated duration: 72 hours))
  • Neonatal distress "asphyxia"(The length of stay in hospital/neonatal intensive care unit (anticipated duration: 72 hours))
  • Duration of labor in hours(Duration of labor (maximum 24 hours))
  • Incidence of oxytocin use(Duration of labor (maximum duration: 24 hours))
  • Incidence of instrumental delivery(Duration of labor (maximum duration: 24 hours))

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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