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

July 10, 2017 updated by: 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Greater Cairo
      • Cairo, Greater Cairo, Egypt, 11956
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

pregnant nulliparous women, at term, during labor

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 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
Time Frame: labor
vaginal delivery or cesarean section
labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Doaa Sh Belal, hospital, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2016

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

February 7, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Kasr El-Aini Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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