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临床试验/NCT02686073
NCT02686073已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2016年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
rate of cervical dilatation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

rate of cervical dilatation

时间窗: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.

in centimeters

次要结局

  • descent of fetal head(every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Shafie Belal

Lecturer

Cairo University

研究点 (1)

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