Newborns of Obese Mothers (MOBENN)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Obstetric management

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. - BMI ≥30 kg / m² or between 18.50 and 24.99 kg / m².
2. - Pregnant woman coming to the centre before 18 weeks of gestation.
3. - Age ≥ 18 and ≤ 40 years
4. - Single Pregnancy
5. - No constitutional or progressive disease other than obesity: inflammatory disease, epilepsy, pathology psychiatric, tumor...
6. - Informed written consent.

Exclusion Criteria:

1. - Pregnant woman coming to the center after 18 weeks of gestation, BMI <18.5 kg / m² or between 25 and 29.99 Kg / m².
2. - Age <18 or> 40 years
3. - Multiple pregnancy
4. - Presence of a constitutional disease or progressive disease other than obesity.
5. - Patients who underwent obesity surgery type "bypass" or gastroplasty
6. - Obesity secondary to genetic disorder, intracranial lesions or pituitary radiotherapy
7. - not stabilized endocrine pathology.
8. - pregestational diabetes
9. - No affiliation to a social security scheme

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obese group	Procedure: Obstetric management; 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.
Active Comparator: Normal Weight group	Procedure: Obstetric management; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: diabetes, obesity, skinfold, newborn
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: P081109