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临床试验/NCT05276947
NCT05276947已完成不适用

The Effect of Peanut Ball Use on Labor Process and Maternal - Neonatal Outcomes in Obese Pregnants

Gulhane Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Labor time

研究概览

简要总结

The purpose of this study is to assess the efficacy of peanut ball use on labor process and maternal, neonatal outcomes in obese pregnant women.

详细描述

After being informed about the study, all participants giving written informed consent, on the active phase of labor (cervical dilatation = 5 cm), the pregnant women in the experimental group will be provided with a position change lasting at least 30 minutes every hour with a peanut ball. The peanut ball will be used with a sheath that is changed for each participant. Pregnant women in the control group will be included in the study during the active phase of labor (cervical dilatation = 5 cm). No intervention will be made by the researcher. They will receive standard care by the service nurse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Admitted for delivery
  • Maternal BMI > 30kg/m2 at admission
  • Gestational age > 37 weeks 0 days
  • Singleton pregnancy
  • Cephalic presentation
  • Cervical dilatation less than 5 cm
  • Turkish speaking

排除标准

  • Pre-pregnancy BMI < 30kg/m2
  • Gestational age < 37 weeks 0 days
  • Multifetal gestation
  • Intrauterine fetal demise
  • Musculoskeletal problems
  • Receiving magnesium sulfate
  • High risk pregnancies (Preeclampsia/eclampsia, cholestasis, intrauterine growth retardation, fetal anomaly, polyhydramnios or oligohydramnios)

结局指标

主要结局

Labor time

时间窗: From 5 cm of cervical dilatation to the second stage of labor

The primary outcome measure is the length of first stage (active phase) and second stage of labor in obese pregnant women.

次要结局

  • Pain level(Latent phase, active phase and at cervical dilatation 10 cm (on contractions))
  • Operative vaginal delivery rate(From 5 cm of cervical dilatation to the expulsion phase of labor)
  • Type of delivery(From 5 cm of cervical dilatation to the expulsion phase of labor)
  • Maternal complications(From 5 cm of cervical dilatation to the expulsion phase of labor)
  • Neonatal complications(From 5 cm of cervical dilatation to the expulsion phase of labor)
  • Birth satisfaction(Postpartum first hour)

研究者

发起方
Gulhane Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fulden Ozkececi

Principal Investigator

Gulhane Training and Research Hospital

研究点 (1)

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