Newborns of Obese Mothers
MOBENN
Impact of Maternal Obesity on Fetal Development and Perinatal Events. Analysis of the Determinants of Fetal Growth.
1 other identifier
interventional
496
0 countries
N/A
Brief Summary
This was a prospective bi-centric study, exposed-unexposed. In an effort to better understand the potential independent effect of maternal obesity on fetal growth, investigators designed a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI \< 25 kg/m2) or obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was screened and treated throughout pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2010
Typical duration for not_applicable obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
February 12, 2016
CompletedApril 6, 2016
February 1, 2016
3.3 years
February 10, 2016
April 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
ponderal index measured by a balance
at birth
skinfold's measure measured by a special clamp
at birth
birthweight
at birth
Study Arms (2)
Obese group
EXPERIMENTALNormal Weight group
ACTIVE COMPARATORInterventions
Screening for gestational diabetes at 32 weeks of gestation, determination of fasting glucose during late pregnancy ; blood samples on arrival at the delivery room ; drawing blood from the umbilical cord after section; skinfold measurement of the newborn within 72 hours of life.
Eligibility Criteria
You may qualify if:
- \- BMI ≥30 kg / m² or between 18.50 and 24.99 kg / m².
- \- Pregnant woman coming to the centre before 18 weeks of gestation.
- \- Age ≥ 18 and ≤ 40 years
- \- Single Pregnancy
- \- No constitutional or progressive disease other than obesity: inflammatory disease, epilepsy, pathology psychiatric, tumor...
- \- Informed written consent.
You may not qualify if:
- \- Pregnant woman coming to the center after 18 weeks of gestation, BMI \<18.5 kg / m² or between 25 and 29.99 Kg / m².
- \- Age \<18 or\> 40 years
- \- Multiple pregnancy
- \- Presence of a constitutional disease or progressive disease other than obesity.
- \- Patients who underwent obesity surgery type "bypass" or gastroplasty
- \- Obesity secondary to genetic disorder, intracranial lesions or pituitary radiotherapy
- \- not stabilized endocrine pathology.
- \- pregestational diabetes
- \- No affiliation to a social security scheme
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2016
First Posted
February 12, 2016
Study Start
July 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
April 6, 2016
Record last verified: 2016-02