Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

Completed

• Conditions: Induced; Birth; Obesity
• Interventions: Drug: Misoprostol

• Registration Number: NCT02788305
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

This study investigate the progression of labour in 144 normal weight pregnant women (BMI \<30) and 144 obese pregnant women (BMI \>30) , not in labor admitted for induction of labor. These women are to be investigated for success of induction of labor.

Detailed Description

* This prospective study will be conducted for 144 obese and 144 non obese ), post date (\>41 wks), not in labor.

* Woman is classified as obese if BMI \>=30.

* Prolonged pregnancy was defined as delivery on or after (41+0 weeks) of gestation.

* First informed consent will be obtained.

* Determination of gestational age

* Proper history taking, general and abdominal examinations will be done then digital examination will be performed to determine bishop score.

* And obstetric U/S scan will be done and by which the following data will be obtained :

* Fetal biometry

* Fetal heart activity

* Presentation

* Localization of the placenta.

* Amount of amniotic fluid.

* Exclude multifetal pregnancy.

* Induction of labor will be done using vaginal misoprostol according to the estimated Bishop score.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-02
• Primary Completion: 2017-05-30
• Study Completion: 2017-06-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 288

Inclusion Criteria

• Pregnant woman.

  • Post date >= 41 weeks.
  • Absent onset of labor.
  • Patient acceptance to join the study after signing an informed consent.

Exclusion Criteria

• Placenta previa and or vasa previa.
• Previous caesarean section(CS).
• Multiple gestation
• Any patient who will refuse to be a part of the study.
• Intra- uterine fetal death (IUFD).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non obese	Misoprostol	BMI\<30. Misoprostol is given for induction of labour according to Bishop score
obese	Misoprostol	BMI\>30. Misoprostol is given for induction of labour according to Bishop score

Primary Outcome Measures

Name	Time	Method
route of delivery vaginal or caesarean section.	48 hours from the start of induction	Partogram is used to access the progress of labour

Secondary Outcome Measures

Name	Time	Method
maternal haemorrhage	48 hours from the start of induction	Calculating number of soaked pads

Trial Locations

Locations (1)

Kasr wl aini hospitals; 🇪🇬 Cairo, Greater Cairo, Egypt