Effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child (SMOOTHIE)

This study evaluates effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child.The data stemming from mothers presenting obesity or an overweight during their pregnancy and the data stemming from mothers having had a by-pass will be compared with the data stemming from mothers with a normal BMI (Body Mass Index), considered as a reference group. It's the same for the data stemming from newborn children. The newborn children stemming from groups of obese mothers or in overweight will be compared with the data stemming from mothers belonging to the reference group.

Study Overview

• Status: Unknown
• Conditions: Maternal Obesity
• Intervention / Treatment: Other: Collection of bloods samples for the mother; Other: Retrieval of umbilical cord blood.; Other: Retrieval of placenta.; Other: Collection of newborn's and mother's lock of hair.; Other: Dietetic Patient Outcomes Questionnaires for the mother.; Other: Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).

Detailed Description

The obesity represents a major problem of public health, not only in terms of inferred morbi-mortality but also in terms of economic responsibility. More than 50 % of the women old enough to procreate and 25 % of the women pregnant in Europe are in overweights or obese women. This rate does not stop increasing with prevalence which doubled in 30 years. The overweight or the maternal obesity expose the mother and the child to a greater risk of morbi-mortality. The nutritional stress to which is exposed the foetus during the pregnancy can even have long-term effects with a risk increased by overweight or obesity at the grown-up age, so participating in the cycle of the obesity (" Developmental Origins of Behaviour, Health, and Disease " (DOBHaD) concept).

The morbid obesity (IMC > 40 kg / m2) concern 1 to 3 % of the pregnant women. The gastric bypass surgery is envisaged in case of morbid obesity when the other treatments failed, with better results on the loss of weight and on the comorbidity associated with the obesity, in comparison with not surgical interventions. Near half of the patients who resort to the gastric bypass surgery are women old enough to procreate. Recent studies however moderated the beneficial effects of such an intervention with in particular a greater risk of intra-uterine delay of growth and possible nutritional deficiencies on the descent. The neonatal evaluation was limited to the clinical evaluation, and no biological evaluation of the vitamin and nutritional deficiencies on the growth of the foetus and the placenta was brought reported.

The placenta regulates the contribution in nutriments and oxygen and participle in the foetal homéostasie. The reactive placentary adaptations to an environment of surnutrition or the undernutrition can pull modifications of setting-up, development, functions of the placenta with genic modifications and épigénétiques. All these modifications intervene in a "critical window" in terms of development and participate in the phenomena of foetal programming.

Our working hypothesis is that the nutritional stress in utero associated with the maternal obesity and/or with the by-pass has a medium and long-term short-term, metabolic and neurodevelopmental nutritional impact on the descent.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Recruiting
    • UHAngers
    • Contact: Geraldine GASCOIN, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• For "Gastric Bypass Surgery" arm :

  • Pregnant women having undergone a Gastric bypass surgery before the pregnancy.

• For "Reference group" arm :

  • Pregnant women having a body mass index < 25 kg/m2 at the early pregnancy.

• For "Overweight" arm :

  • Pregnant women having a body mass index 25-30 kg/m2 at the early pregnancy.

• For "Obesity " arm :

  • Pregnant women having a body mass index > 30 kg/m2 at the early pregnancy.

Exclusion Criteria:

• For every arms :

  • Underage women
  • Woman with a multiple pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Gastric bypass surgery; Pregnant women having undergone a Gastric bypass surgery before the pregnancy.; Collection of bloods samples for the mother.; Retrieval of umbilical cord blood.; Retrieval of placenta.; Collection of newborn's and mother's lock of hair.; Dietetic patient outcomes questionnaires for the mother.; Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).	Other: Collection of bloods samples for the mother; -During pregnancy, childbirth and after delivery; Other: Retrieval of umbilical cord blood.; -During childbirth; Other: Retrieval of placenta.; -During childbirth; Other: Collection of newborn's and mother's lock of hair.; -During childbirth; Other: Dietetic Patient Outcomes Questionnaires for the mother.; -During pregnancy and after delivery; Other: Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).; -At 2 years of age
Other: Reference group; Pregnant women having a body mass index <25 kg/m2 at the early pregnancy.; Collection of bloods samples for the mother.; Retrieval of umbilical cord blood.; Retrieval of placenta.; Collection of newborn's and mother's lock of hair.; Dietetic patient outcomes questionnaires for the mother.; Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).	Other: Collection of bloods samples for the mother; -During pregnancy, childbirth and after delivery; Other: Retrieval of umbilical cord blood.; -During childbirth; Other: Retrieval of placenta.; -During childbirth; Other: Collection of newborn's and mother's lock of hair.; -During childbirth; Other: Dietetic Patient Outcomes Questionnaires for the mother.; -During pregnancy and after delivery; Other: Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).; -At 2 years of age
Other: Overweight; Pregnant women having a body mass index 25-30 kg/m2 at the early pregnancy.; Collection of bloods samples for the mother.; Retrieval of umbilical cord blood.; Retrieval of placenta.; Collection of newborn's and mother's lock of hair.; Dietetic patient outcomes questionnaires for the mother.; Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).	Other: Collection of bloods samples for the mother; -During pregnancy, childbirth and after delivery; Other: Retrieval of umbilical cord blood.; -During childbirth; Other: Retrieval of placenta.; -During childbirth; Other: Collection of newborn's and mother's lock of hair.; -During childbirth; Other: Dietetic Patient Outcomes Questionnaires for the mother.; -During pregnancy and after delivery; Other: Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).; -At 2 years of age
Other: Obesity; Pregnant women having a body mass index > 30 kg/m2 at the early pregnancy.; Collection of bloods samples for the mother.; Retrieval of umbilical cord blood.; Retrieval of placenta.; Collection of newborn's and mother's lock of hair.; Dietetic patient outcomes questionnaires for the mother.; Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).	Other: Collection of bloods samples for the mother; -During pregnancy, childbirth and after delivery; Other: Retrieval of umbilical cord blood.; -During childbirth; Other: Retrieval of placenta.; -During childbirth; Other: Collection of newborn's and mother's lock of hair.; -During childbirth; Other: Dietetic Patient Outcomes Questionnaires for the mother.; -During pregnancy and after delivery; Other: Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).; -At 2 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Born measurement (weight) expressed in z-score.	Z-scores are "pure numbers" (have no units of measurement attached to them).	At the childbirth
Born measurement (height) expressed in z-score.	Z-scores are "pure numbers" (have no units of measurement attached to them).	At the childbirth
Born measurement (cranial perimeter) expressed in z-score.	Z-scores are "pure numbers" (have no units of measurement attached to them).	At the childbirth.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modification of auxological data (weight) at the age of 2.	Weight expressed in kilograms.	At the age of 2.
Modification of auxological data (height) at the age of 2.	Height expressed in centimeters.	At the age of 2.
Modification of auxological data (cranial perimeter) at the age of 2.	Cranial perimeter expressed in centimeters.	At the age of 2.
Modification of auxological data (BMI (Body Mass Index)) at the age of 2.	BMI (Body Mass Index) expressed in kg/m².	At the age of 2.
Modification of auxological data (speed of growth expressed) at the age of 2.	Speed of growth expressed in centimeters per year.	At the age of 2.
Neurodevelopmental modifications at the age of 2.	Parental questionnaire : Ages & Stages Questionnaires (ASQ).	At the age of 2.
Modifications of eating habits at the age of 2.	Parental questionnaire : Child Feeding Questionnaire (CFQ).	At the age of 2.
Vitamin dosages and micronutrients in the blood of cordon.	Dosages.	At the childbirth.
Vitamin dosages and maternal micronutrients in the first, second, third quarter of the pregnancy, at the childbirth and in 2 months after delivery.	Dosages.	First, second, third quarter of the pregnancy, at the childbirth and in 2 months after delivery.

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Geraldine GASCOIN, Pr, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Obesity; Obesity, Maternal
• Other Study ID Numbers: 2016-A01546-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No