- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686073
Effect of Maternal Body Mass Index on Labor Progress in Nulliparous Women
Revising the Norms of Labor Progress in Egyptian Nulliparous Women in Relation to Maternal Body Mass Index Categories
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Greater Cairo
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Cairo, Greater Cairo, Egypt, 11956
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group A
Underweight participants whose body mass index is less than 18.5 kg/m2
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Group B
Control group, in which the participants belong to the normal body mass index range , from 18.5 to 29.9 kg/m2
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Group C
Obese participants whose body mass index is more than or equal to 30 kg/m2.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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in centimeters
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every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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head station
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every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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total duration in hours
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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
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duration of second stage of labor
Time Frame: from start of second stage of labor ( full cervical dilatation) until delivery of fetus
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total duration in minutes
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from start of second stage of labor ( full cervical dilatation) until delivery of fetus
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mode of delivery
Time Frame: labor
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vaginal delivery or cesarean section
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labor
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Doaa Sh Belal, hospital, Cairo University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Kasr El-Aini Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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