The Impact of Maternal Obesity on Pregnancy Outcomes in El-Minia Locality

July 14, 2017 updated by: Reham Elkhateeb, Minia University

The Impact of Maternal Obesity on Pregnancy Outcomes in El-Minia Locality a Case Control Survey Study

A study will carried out over a period of one year , all obese pregnant women as diagnosed with BMI at the time of 1st ANC visit and before labor ,observation of events during both intra-partum &postpartum periods it will be recorded.outcome will compared with normal other pregnant women

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is known that obesity during pregnancy has drawbacks for both maternal and foetal outcome The aim of this study is to evaluate and measure the proportion of the adverse pregnancy outcomes attributable to maternal obesity and so reaching to recommendations in order to improve the outcomes and wellbeing of these women and their children.patient will be divided into two groups control group with normal BMI and study group and both compared as regard foetal and maternal outcome The assessed fetal variables will be: fetal birthweight & incubators admission. Data will be retrieved from patients before labor and from investigator observation both intrapartum and postpartum.

Study Type

Observational

Enrollment (Actual)

330

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
      • Minia, Egypt, 61519
        • Minia University

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

pregnant women with BMI more than 24 per meter square body surface area

Description

Inclusion Criteria:

  • obese
  • pregnant
  • age 18 -40
  • single viable cephalic foetus

Exclusion Criteria:

less than 18 years more than 40 years associated medical disorders patient refusal non cephalic presentation

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
the group with normal BMI
study group
The group with the BMI more than 24.9 kg per meter square to study the impact of maternal obesity in pregnancy outcome
Other: The impact of maternal obesity on pregnancy outcomes
observation of maternal obesity effect in foetal and maternal outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: onset of labor till end
vaginal or Cesarean section
onset of labor till end
shoulder dystocia
Time Frame: 1 minute after delivery of the head
arrest of shoulder more than one minute after delivery of the head
1 minute after delivery of the head
foetal macrosomia
Time Frame: at time of labour or elective CS
foetal weight at time of delivery more than 90th percentil
at time of labour or elective CS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postpartum hemorrhage
Time Frame: onset of labor and for 6 weeks after
primary or secondary blood loss through birth canal more than 500cc
onset of labor and for 6 weeks after
postpatum maternal infection
Time Frame: end of labor and for 6weeks after
postpartum signs of sepsis
end of labor and for 6weeks after
neonatal ICU admission
Time Frame: one month after delivery
neonatal ICU admission
one month after delivery

Collaborators and Investigators

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

Sponsor

Minia University

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

August 1, 2016

Primary Completion (Actual)

July 14, 2017

Study Completion (Actual)

July 14, 2017

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOI in pregnancy outcome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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