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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03084120
Acronym
SMOOTHIE
Enrollment
240
Registered
2017-03-20
Start date
2017-05-10
Completion date
2022-08-01
Last updated
2017-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Obesity

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.

Interventions

OTHERCollection of bloods samples for the mother

-During pregnancy, childbirth and after delivery

OTHERRetrieval of umbilical cord blood.

-During childbirth

OTHERRetrieval of placenta.

-During childbirth

OTHERCollection of newborn's and mother's lock of hair.

-During childbirth

OTHERDietetic Patient Outcomes Questionnaires for the mother.

-During pregnancy and after delivery

OTHERParental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).

-At 2 years of age

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

a prospective monocentric study, not therapeutic, and physiopathological

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Born measurement (weight) expressed in z-score.At the childbirthZ-scores are pure numbers (have no units of measurement attached to them).
Born measurement (height) expressed in z-score.At the childbirthZ-scores are pure numbers (have no units of measurement attached to them).
Born measurement (cranial perimeter) expressed in z-score.At the childbirth.Z-scores are pure numbers (have no units of measurement attached to them).

Secondary

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

Countries

France

Contacts

Primary ContactElsa BERARDI
elberardi@chu-angers.fr+33 2 41 35 61 79

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026