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Completed

NCT Number: NCT02686073

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

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.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Cairo, Greater Cairo, 11956, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. rate of cervical dilatation

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

    in centimeters

Secondary outcomes

  1. descent of fetal head

    Time frame: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor

    head station

Other outcomes

  1. duration of active phase of labor

    Time frame: 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

  2. duration of second stage of labor

    Time frame: from start of second stage of labor ( full cervical dilatation) until delivery of fetus

    total duration in minutes

  3. mode of delivery

    Time frame: labor

    vaginal delivery or cesarean section

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2016
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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