Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

October 13, 2017 updated by: heba mahmoud ibrahim marie, Kasr El Aini Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

288

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Greater Cairo
      • Cairo, Greater Cairo, Egypt, 11956
        • Kasr wl aini hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

144 pregnant women with BMI >= 30 and 144 pregnant women with BMI <30, post date >= 41 wks, not in labor admitted in Kaselaini H for induction of labor.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non obese
BMI<30. Misoprostol is given for induction of labour according to Bishop score
Drug: Misoprostol
Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups
obese
BMI>30. Misoprostol is given for induction of labour according to Bishop score
Drug: Misoprostol
Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
route of delivery vaginal or caesarean section.
Time Frame: 48 hours from the start of induction
Partogram is used to access the progress of labour
48 hours from the start of induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal haemorrhage
Time Frame: 48 hours from the start of induction
Calculating number of soaked pads
48 hours from the start of induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Heba M Marie, M.D., kasrelaini hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 13, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9898 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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