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

University Hospital, Angers

Status: Unknown

Conditions: Maternal Obesity

Treatments: Other: Retrieval of placenta.; Other: Retrieval of umbilical cord blood.; Other: Dietetic Patient Outcomes Questionnaires for the mother.; Other: Collection of bloods samples for the mother; Other: Collection of newborn's and mother's lock of hair.; Other: Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).

Study type: Interventional

Funder types: Other

Identifiers

NCT03084120

2016-A01546-45

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

Gastric bypass surgery

Other group

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).

Treatment:

Other: Retrieval of placenta.

Other: Collection of newborn's and mother's lock of hair.

Other: Retrieval of umbilical cord blood.

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

Other: Collection of bloods samples for the mother

Other: Dietetic Patient Outcomes Questionnaires for the mother.

Reference group

Other group

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).

Treatment:

Other: Retrieval of placenta.

Other: Collection of newborn's and mother's lock of hair.

Other: Retrieval of umbilical cord blood.

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

Other: Collection of bloods samples for the mother

Other: Dietetic Patient Outcomes Questionnaires for the mother.

Overweight

Other group

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).

Treatment:

Other: Retrieval of placenta.

Other: Collection of newborn's and mother's lock of hair.

Other: Retrieval of umbilical cord blood.

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

Other: Collection of bloods samples for the mother

Other: Dietetic Patient Outcomes Questionnaires for the mother.

Obesity

Other group

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).

Treatment:

Other: Retrieval of placenta.

Other: Collection of newborn's and mother's lock of hair.

Other: Retrieval of umbilical cord blood.

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

Other: Collection of bloods samples for the mother

Other: Dietetic Patient Outcomes Questionnaires for the mother.