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

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ClinicalTrials.gov Identifier: NCT02719873
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Reham Elkhateeb, Minia University

Brief Summary:
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

Condition or disease Intervention/treatment
Obesity During Pregnancy in Clinical Practice Other: The impact of maternal obesity on pregnancy outcomes

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
Actual Enrollment : 330 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Impact of Maternal Obesity on Pregnancy Outcomes in El-Minia Locality a Case Control Survey Study
Study Start Date : August 2016
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017

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




Primary Outcome Measures :
  1. Mode of delivery [ Time Frame: onset of labor till end ]
    vaginal or Cesarean section

  2. shoulder dystocia [ Time Frame: 1 minute after delivery of the head ]
    arrest of shoulder more than one minute after delivery of the head

  3. foetal macrosomia [ Time Frame: at time of labour or elective CS ]
    foetal weight at time of delivery more than 90th percentil


Secondary Outcome Measures :
  1. postpartum hemorrhage [ Time Frame: onset of labor and for 6 weeks after ]
    primary or secondary blood loss through birth canal more than 500cc

  2. postpatum maternal infection [ Time Frame: end of labor and for 6weeks after ]
    postpartum signs of sepsis

  3. neonatal ICU admission [ Time Frame: one month after delivery ]
    neonatal ICU admission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women with BMI more than 24 per meter square body surface area
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719873


Locations
Egypt
Minia University
Minia, Egypt, 61519
Sponsors and Collaborators
Minia University

Publications of Results:
Responsible Party: Reham Elkhateeb, doctor, Minia University
ClinicalTrials.gov Identifier: NCT02719873     History of Changes
Other Study ID Numbers: MOI in pregnancy outcome
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Reham Elkhateeb, Minia University:
obesity , pregnancy , maternal and fetal outcome

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms