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临床试验/NCT04729426
NCT04729426已完成不适用

The Effect of Using a Birthing Ball During Labor on the Labor Process

Gonca Karataş Baran1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2021年2月1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
101
试验地点
1
主要终点
Labor time

研究概览

简要总结

In this study, it was aimed to position by using peanut ball, which is a kind of birth ball, in the first stage of delivery in pregnant women who are planned to have vaginal delivery with cephalic admission, who is a primipara, who do not have a risky pregnancy and systemic disease; It will be done to determine the effect on the birth process.

详细描述

The group of healthy pregnant women who meet the inclusion criteria will be determined by randomization according to the order of application to the delivery room in the latent phase. Positions will be changed every 30 minutes using the peanut ball tool in a group (intervention group) in active phase and transition phase. These positions are; side-lying position, compressed side-lying position, semi-sitting position, forward leaning position, upright sitting position and pushing position. All positions will be given to the pregnant woman by the researcher and she will be with the pregnant woman during the position intervention. How to give the peanut ball positions is indicated in the flow chart with photographs. Position application will not be applied to the other group (control group), routine procedure of the hospital will be applied.

Parameters to Look for:

The researcher will evaluate the progress of the birth process (cervical dilatation and effacement, fetal head descent, Fetal Hearth Rate, duration of the first and second stages of labor), delivery method and information about the baby (gender, weight, height and head circumference length, APGAR) in both groups of women from the hospital's partograph records. Information on the progress of the birth process from the active phase of each pregnant birth to the completion of the birth process in the hospital is processed in the partograph with 30 minutes intervals.

The pain level in each stage and phases of labor will be evaluated by the researcher with a visual pain scale.

The first breastfeeding process will be observed and evaluated by the researcher using the "LATCH Breastfeeding Diagnostic and Evaluation Scale" in the delivery room.

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
Single (Participant)

盲法说明

The volunteer who is in the latent phase of labor will not know which group she will be in before joining the study. After accepting to participate in the study, the volunteer will be informed about which group she will be in.

入排标准

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

入选标准

  • Primiparous at 37-42 weeks of gestation,
  • between the ages of 18-40,
  • Not diagnosed with risky pregnancy (Intrauterine Growth Retardation, Fetal Anomaly, Polyhydramnios or Oligohydraamnios, Thromboembolic Diseases, Presentation Anomalies, Premature Membrane Rupture, Multiple Pregnancy, Sexually Transmitted Disease, Preeclampsia / Eclampsia etc.)
  • Without systemic disease (Hypertension, Heart Disease, Diabetes, Asthma, Thyroid, Epilepsy, etc.)
  • Single pregnancy,
  • Vaginal delivery planned with cephalic admission,
  • in the latent phase of labor,
  • Epidural anesthesia / analgesia was not applied,
  • Volunteering to participate in research,
  • Pregnant women who do not have any communication disorder will be taken.

排除标准

  • Failure to meet the inclusion criteria is the exclusion criteria.
  • Exclusion (Withdrawal) from the Study Criteria
  • Having adaptation problems in applying the positions to be given,
  • Maternal (vital signs deviation from normal, hyperstimulation, abnormal bleeding, etc.) and fetal complications (such as fetal distress, cord entanglement, cord prolapse) during delivery,
  • Caesarean section, which could not complete the normal birth process,
  • Pregnant women who give up working at any stage of the study will be excluded from the study.

结局指标

主要结局

Labor time

时间窗: max 8 hour

Firsth stage ( active phase and transition phase) time+ and second stage labor time=...minutes

次要结局

  • cervical dilation(max 8 hour)
  • cervical effacement(max 8 hour)
  • fetal head level(max 8 hour)
  • The pain level(max 8 hour)
  • The first breastfeeding process evaluation(within 30 minutes after labor)
  • maternal satisfaction(within 30 minutes to two hours after labor)

研究者

发起方
Gonca Karataş Baran
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gonca Karataş Baran

Ankara Yildirim Beyazıt University Student

Ankara Yildirim Beyazıt University

研究点 (1)

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