Newborns of Obese Mothers

Study Overview
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Brief Summary
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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.

Detailed Description
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The study population concerned obese pregnant women (BMI ≥ 30 kg / m² before pregnancy) and their newborn and normal weight pregnant women (18.5 ≤IMC <25 kg/m²) and their newborn as control. Inclusion criteria were body mass index (BMI) ≥ 30 kg/m2 or 18.5 ≤ BMI < 25 kg/m2, 18 ≤ age ≤ 40 years, singleton pregnancy. Exclusion criteria were: 25 ≤ BMI <30 kg/m2, age < 18 or > 40 years, multiple pregnancy, first consultation after 18 WG, pregestational diabetes, obesity due to genetic disorder or secondary to intracranial tumor or radiotherapy, bariatric surgery, chronic diseases other than the obesity, inability to converse in French language. The matching criteria for controls were: age ± 5 years, primigravida or multigravida, duration of gestation ± 4 weeks. The main objective of this project was to assess the independent effect of maternal obesity: on the weight and adipose tissue of newborn on the function of adipose tissue (production of leptin and adiponectin) on fetal growth factors (C-peptide, IGF-1) on carbohydrate metabolism of the newborn. Two maternities were involved in the study: Pitié Salpêtrière and Armand Trousseau, in Paris, France. This research was conducted over a 3 years period. The duration of participation of each woman corresponded to the duration of pregnancy care and duration of care for the newborn immediately after birth, usually the length of stay in the maternity. The only differences compared to the usual care included: Additional oral glucose tolerance test at 32 weeks of gestation; Determination of fasting blood glucose during late pregnancy Maternal 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.

Official Title
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Impact of Maternal Obesity on Fetal Development and Perinatal Events. Analysis of the Determinants of Fetal Growth.

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Obstetric management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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. Exclusion Criteria: - 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese group<br> | Procedure: Obstetric management<br>* 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.<br>|
| Active Comparator: Normal Weight group<br> | Procedure: Obstetric management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ponderal index measured by a balance |  | at birth | 
| skinfold's measure measured by a special clamp |  | at birth | 
| birthweight |  | at birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, obesity, skinfold, newborn