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Effect of Maternal Body Mass Index on Labor Progress in Nulliparous Women

2017年7月10日 更新者:Doaa Shafie Belal、Cairo University

Revising the Norms of Labor Progress in Egyptian Nulliparous Women in Relation to Maternal Body Mass Index Categories

Study the rate of progress of labor among nulliparous women belonging to different body mass index groups, & observe how does this variation in maternal body mass index may affect the course of labor.

研究概览

地位

完全的

条件

详细说明

For nulliparous cases presenting to the labor ward, maternal height & weight will be collected at the time of admission to calculate the BMI (body mass index) & further classified according to WHO (World Health Organization) categories. Putting into consideration the physiological increase in BMI related to pregnancy, the overweight participants whose BMI (25-29.9) will be combined with the normal range BMI (18.5-24.9) category. Labor characteristics of these participants will be then compared with those of the underweight (BMI less than 18.5) & obese (BMI 30 or higher) participants.Females are assigned in one of 3 groups based on their BMI; Underweight group (BMI <18.5kg/m2), Control group whose BMI within normal range (18.5-29.9 kg/m2),& Obese group (BMI more than or equal 30kg/m2).

Labor management protocols are fixed. Data on labor progression are collected, including cervical dilatation, cervical effacement, head station & descent. The median duration of labor , estimated by rate of cervical dilatation in cm, will be used as a measurement of labor progression in each group.

A cesarean section for abnormal labor pattern will be documented as failure of progress.

研究类型

观察性的

注册 (实际的)

600

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Greater Cairo
      • Cairo、Greater Cairo、埃及、11956
        • Cairo University

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

20年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

pregnant nulliparous women, at term, during labor

描述

Inclusion Criteria:

  • nulliparous women in active phase of labor, with an age range from 20 to 40 years.

Full term pregnancy, singleton, viable fetus, cephalic (vertex) presentation, occipito-anterior position.

Exclusion Criteria:

  • Multiparous women. Preterm labor. Passed date delivery. Multiple gestation. Large fetal weight (more than 4000g). Intrauterine fetal death. Intrauterine fetal growth restriction. Major fetal congenital anomalies. Rupture of membranes before onset of active labor. Fetal malposition or malpresentation. Inadequate pelvis or cephalopelvic disproportion. Maternal medical disorder.

Induction of labor by oxytocin or prostaglandins. Conditions requiring urgent delivery eg antepartum haemorrhage, fetal distress, cord prolapse.

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

队列和干预

团体/队列
Group A
Underweight participants whose body mass index is less than 18.5 kg/m2
Group B
Control group, in which the participants belong to the normal body mass index range , from 18.5 to 29.9 kg/m2
Group C
Obese participants whose body mass index is more than or equal to 30 kg/m2.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
rate of cervical dilatation
大体时间:every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.
in centimeters
every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.

次要结果测量

结果测量
措施说明
大体时间
descent of fetal head
大体时间:every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor
head station
every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor

其他结果措施

结果测量
措施说明
大体时间
duration of active phase of labor
大体时间:all through the course of labor, individually assessed for each participant, starting from the time of admission to labor ward until start of second stage of labor
total duration in hours
all through the course of labor, individually assessed for each participant, starting from the time of admission to labor ward until start of second stage of labor
duration of second stage of labor
大体时间:from start of second stage of labor ( full cervical dilatation) until delivery of fetus
total duration in minutes
from start of second stage of labor ( full cervical dilatation) until delivery of fetus
mode of delivery
大体时间:labor
vaginal delivery or cesarean section
labor

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

  • 首席研究员:Doaa Sh Belal, hospital、Cairo University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2016年2月20日

初级完成 (实际的)

2017年2月28日

研究完成 (实际的)

2017年2月28日

研究注册日期

首次提交

2016年2月7日

首先提交符合 QC 标准的

2016年2月18日

首次发布 (估计)

2016年2月19日

研究记录更新

最后更新发布 (实际的)

2017年7月12日

上次提交的符合 QC 标准的更新

2017年7月10日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Kasr El-Aini Hospital

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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