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

NCT ID: NCT02686073

Last Updated: 2017-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-20

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Labor Progress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Underweight participants whose body mass index is less than 18.5 kg/m2

No interventions assigned to this group

Group B

Control group, in which the participants belong to the normal body mass index range , from 18.5 to 29.9 kg/m2

No interventions assigned to this group

Group C

Obese participants whose body mass index is more than or equal to 30 kg/m2.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Shafie Belal

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doaa Sh Belal, hospital

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Cairo, Greater Cairo, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 28886213 (View on PubMed)

Other Identifiers

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Kasr El-Aini Hospital

Identifier Type: -

Identifier Source: org_study_id

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