search
Back to results

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

Primary Purpose

Maternal Obesity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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).
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Maternal Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UHAngersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Gastric bypass surgery

Reference group

Overweight

Obesity

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Born measurement (weight) expressed in z-score.
Z-scores are "pure numbers" (have no units of measurement attached to them).
Born measurement (height) expressed in z-score.
Z-scores are "pure numbers" (have no units of measurement attached to them).
Born measurement (cranial perimeter) expressed in z-score.
Z-scores are "pure numbers" (have no units of measurement attached to them).

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2017
Last Updated
November 29, 2017
Sponsor
University Hospital, Angers
search

1. Study Identification

Unique Protocol Identification Number
NCT03084120
Brief Title
Effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child
Acronym
SMOOTHIE
Official Title
Effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Obesity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
a prospective monocentric study, not therapeutic, and physiopathological
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastric bypass surgery
Arm Type
Other
Arm Description
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).
Arm Title
Reference group
Arm Type
Other
Arm Description
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).
Arm Title
Overweight
Arm Type
Other
Arm Description
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).
Arm Title
Obesity
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Collection of bloods samples for the mother
Intervention Description
-During pregnancy, childbirth and after delivery
Intervention Type
Other
Intervention Name(s)
Retrieval of umbilical cord blood.
Intervention Description
-During childbirth
Intervention Type
Other
Intervention Name(s)
Retrieval of placenta.
Intervention Description
-During childbirth
Intervention Type
Other
Intervention Name(s)
Collection of newborn's and mother's lock of hair.
Intervention Description
-During childbirth
Intervention Type
Other
Intervention Name(s)
Dietetic Patient Outcomes Questionnaires for the mother.
Intervention Description
-During pregnancy and after delivery
Intervention Type
Other
Intervention Name(s)
Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).
Intervention Description
-At 2 years of age
Primary Outcome Measure Information:
Title
Born measurement (weight) expressed in z-score.
Description
Z-scores are "pure numbers" (have no units of measurement attached to them).
Time Frame
At the childbirth
Title
Born measurement (height) expressed in z-score.
Description
Z-scores are "pure numbers" (have no units of measurement attached to them).
Time Frame
At the childbirth
Title
Born measurement (cranial perimeter) expressed in z-score.
Description
Z-scores are "pure numbers" (have no units of measurement attached to them).
Time Frame
At the childbirth.
Secondary Outcome Measure Information:
Title
Modification of auxological data (weight) at the age of 2.
Description
Weight expressed in kilograms.
Time Frame
At the age of 2.
Title
Modification of auxological data (height) at the age of 2.
Description
Height expressed in centimeters.
Time Frame
At the age of 2.
Title
Modification of auxological data (cranial perimeter) at the age of 2.
Description
Cranial perimeter expressed in centimeters.
Time Frame
At the age of 2.
Title
Modification of auxological data (BMI (Body Mass Index)) at the age of 2.
Description
BMI (Body Mass Index) expressed in kg/m².
Time Frame
At the age of 2.
Title
Modification of auxological data (speed of growth expressed) at the age of 2.
Description
Speed of growth expressed in centimeters per year.
Time Frame
At the age of 2.
Title
Neurodevelopmental modifications at the age of 2.
Description
Parental questionnaire : Ages & Stages Questionnaires (ASQ).
Time Frame
At the age of 2.
Title
Modifications of eating habits at the age of 2.
Description
Parental questionnaire : Child Feeding Questionnaire (CFQ).
Time Frame
At the age of 2.
Title
Vitamin dosages and micronutrients in the blood of cordon.
Description
Dosages.
Time Frame
At the childbirth.
Title
Vitamin dosages and maternal micronutrients in the first, second, third quarter of the pregnancy, at the childbirth and in 2 months after delivery.
Description
Dosages.
Time Frame
First, second, third quarter of the pregnancy, at the childbirth and in 2 months after delivery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elsa BERARDI
Phone
+33 2 41 35 61 79
Email
elberardi@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geraldine GASCOIN, Pr
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHAngers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geraldine GASCOIN, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs