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

Labor Progress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686073
• Other study ID #: Kasr El-Aini Hospital
• Status: Completed
• Phase: N/A
• First received: February 7, 2016
• Last updated: July 10, 2017
• Start date: February 20, 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Progress

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Greater Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of active phase 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
Other	duration of second stage of labor	total duration in minutes	from start of second stage of labor ( full cervical dilatation) until delivery of fetus
Other	mode of delivery	vaginal delivery or cesarean section	labor
Primary	rate of cervical dilatation	in centimeters	every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.
Secondary	descent of fetal head	head station	every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor