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Completed

NCT Number: NCT02681588

Newborns of Obese Mothers

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obstetric management

Procedure

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.

Primary outcomes

  1. ponderal index measured by a balance

    Time frame: at birth

  2. skinfold's measure measured by a special clamp

    Time frame: at birth

  3. birthweight

    Time frame: at birth

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MOBENN

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 12, 2016
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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