Clinical trial NCT02686073: Effect of Maternal Body Mass Index on Labor Progress in Nulliparous Women
Official title: Revising the Norms of Labor Progress in Egyptian Nulliparous Women in Relation to Maternal Body Mass Index Categories
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Progress
Keywords: BMI
progress of labor
nulliparous women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant nulliparous women, at term, during labor

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: rate of cervical dilatation
timeFrame: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.
Secondary outcomes:
measure: descent of fetal head
timeFrame: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor
Other outcomes:
measure: duration of active phase of labor
timeFrame: 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
measure: duration of second stage of labor
timeFrame: from start of second stage of labor ( full cervical dilatation) until delivery of fetus
measure: mode of delivery
timeFrame: labor
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Greater Cairo
Study officials:
affiliation: Cairo University
name: Doaa Sh Belal, hospital
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maged AM, Belal DS, Marie HM, Rashwan H, Abdelaziz S, Gabr AA, Elzayat AR. Prospective study of the effect of maternal body mass index on labor progress in nulliparous women in Egypt. Int J Gynaecol Obstet. 2017 Dec;139(3):329-335. doi: 10.1002/ijgo.12322. Epub 2017 Oct 3.