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Effect of the Length of Second Stage of Labor in Primigravidae on Maternal & Neonatal Outcomes (RCT)

2016年2月4日 更新者:Mohamed El-Sharkawy、Kasr El Aini Hospital
The primary purpose of this study is to compare the effects of two different methods of care during the second stage of labor for nulliparous women (coached versus uncoached pushing) on the length of the second stage and how this may affect maternal and neonatal outcome.

研究概览

详细说明

The study was conducted on 434 primigravidae women admitted to Kasr El Ainy teaching Maternity Hospital for labor. The study will be done in the period between October 2015 and April 2016. The study will include 434 women with the diagnosis of the first stage of labor with at least cervical dilatation 4cm.

Ethical approval obtained and an informed consent will be taken from each patient after explaining the nature and scope of the study.

Methodology in details:

  1. Careful and detailed history taking regarding:

    • Personal history
    • Complaint.
    • History of present pregnancy.
    • Menstrual History.
    • Past history.
  2. Careful general examination.
  3. Abdominal examination.
  4. Local vaginal examination.
  5. Ultrasound examination.

Management of Cases:

Group (I)(Coached group):

It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.

Group (II)(Uncoached group):

It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .

Patients admitted early in labor are subjected to active management of labor as follows:

Pelvic examination performed. Routine amniotomy performed and progress assessed. When dilatation is not increasing, a low dose protocol of oxytocin infusion will be started. Oxytocin diluted in the form of 5IU in 500 ml Ringer lactate making a concentration of nearly 1mu oxytocin/1ml Ringer solution. Infusion instituted at a rate of 1 -2 milliunit (15-30 drops) per minute and increased gradually in increments of 1 -2 milliunit per minute at 30 minutes interval, until at least three uterine contractions noted in a 10 minute period using cardio tocograph.

Assessment of each stage of labor was performed as follow:

  1. First stage of labor:

    It includes:

    • Duration of the first stage of labor.
    • Rate of cervical dilatation and foetal descent.
    • Adequacy of uterine contractions and documentation of labor dystocia.
    • Excess uterine activity consisted of uterine tachysystole, hypertonus or uterine hyperstimulation
  2. Second stage of labor:

    It includes:

    • Duration of the second stage.
    • Rate of the descent of foetus.
    • Monitoring of foetal heart rate every 5 minutes by sonicaid or continuous by CTG.
    • Use of mediolateral episiotomy.
    • Intervention will be considered either by instrumental delivery,fundal pressure or by CS If the second stage is prolonged more than 2 hours.
    • Monitoring of maternal oxygen saturation by pulse oximeter.
  3. Third stage of labor:

    - Duration of the third stage.

  4. Assessment of any vaginal laceration or perineal tears with their repair as well as repair of episiotomy.
  5. Assessment of quantity of blood loss and assessment of uterine atony(vital instability,number of soaked pads and hemoglobin drop) .
  6. Rate of caesarean section during varying stages of labor.
  7. Neonatal assessment:

It includes:

  • Foetal sex and body weight.
  • APGAR score at 1 and 5 minutes..

研究类型

观察性的

注册 (预期的)

434

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 35年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

概率样本

研究人群

The study was conducted on 434 primigravidae women admitted to Kasr El Ainy teaching Maternity Hospital for labor. The study will be done in the period between October 2015 and April 2016. The study will include 434 women with the diagnosis of the first stage of labor with at least cervical dilatation 4cm.

描述

Inclusion Criteria:

All patients admitted in the first stage of labor with cervical dilatation of 4 cm at least:

  1. Women age 18-35 years.
  2. 37-41 weeks gestation pregnancy.
  3. Singleton pregnancy and vertex presentation.
  4. Women have no chronic or pregnancy-induced illnesses.
  5. Women are in established, spontaneous labor.

Exclusion Criteria:

  1. Malpresentation.
  2. Women with previous uterine scar.
  3. Multiple pregnancy
  4. Ante partum hemorrhage.
  5. Cephalopelvic disproportion.
  6. Women have chronic illnesses.
  7. Women with abnormal antenatal period.
  8. Patients with foetal distress
  9. Premature rupture of membrane
  10. Woman having any contraindication to vaginal delivery.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
1

Group (I)(Coached group):

It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.

It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.
2
It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth.
It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Duration of the second stage
大体时间:0-3 hours
0-3 hours

次要结果测量

结果测量
大体时间
Severe maternal morbidity e.g post partum hemorrhage
大体时间:intrapartum and 2 hours postpartum.
intrapartum and 2 hours postpartum.
APGAR score after one and five minutes.
大体时间:1-5 minutes
1-5 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Kasr El Ainy, hospital、kasr el ainy street,cairo,egypt

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年11月1日

初级完成 (预期的)

2016年5月1日

研究完成 (预期的)

2016年5月1日

研究注册日期

首次提交

2015年11月20日

首先提交符合 QC 标准的

2016年2月4日

首次发布 (估计)

2016年2月8日

研究记录更新

最后更新发布 (估计)

2016年2月8日

上次提交的符合 QC 标准的更新

2016年2月4日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • KasrELAini maternity hospital

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