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

NCT02686073 | Completed DMC

• 1 other identifier: Kasr El-Aini Hospital
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Progress

Keywords

BMI; progress of labor; nulliparous women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• descent of fetal head

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

Other Outcomes (3)

• duration of active phase of labor

  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

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

• mode of delivery

  labor

Study Arms (3)

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.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

pregnant nulliparous women, at term, during labor

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Greater Cairo, 11956, Egypt

Location

Related Publications (1)

• 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.

  PMID: 28886213 DERIVED

Study Officials

• Doaa Sh Belal, hospital

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 7, 2016
• First Posted: February 19, 2016
• Study Start: February 20, 2016
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

EG (1)