Effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child
NCT ID: NCT03084120
Last Updated: 2017-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2017-05-10
2022-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
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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).
Collection of bloods samples for the mother
-During pregnancy, childbirth and after delivery
Retrieval of umbilical cord blood.
-During childbirth
Retrieval of placenta.
-During childbirth
Collection of newborn's and mother's lock of hair.
-During childbirth
Dietetic Patient Outcomes Questionnaires for the mother.
-During pregnancy and after delivery
Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).
-At 2 years of age
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).
Collection of bloods samples for the mother
-During pregnancy, childbirth and after delivery
Retrieval of umbilical cord blood.
-During childbirth
Retrieval of placenta.
-During childbirth
Collection of newborn's and mother's lock of hair.
-During childbirth
Dietetic Patient Outcomes Questionnaires for the mother.
-During pregnancy and after delivery
Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).
-At 2 years of age
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).
Collection of bloods samples for the mother
-During pregnancy, childbirth and after delivery
Retrieval of umbilical cord blood.
-During childbirth
Retrieval of placenta.
-During childbirth
Collection of newborn's and mother's lock of hair.
-During childbirth
Dietetic Patient Outcomes Questionnaires for the mother.
-During pregnancy and after delivery
Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).
-At 2 years of age
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).
Collection of bloods samples for the mother
-During pregnancy, childbirth and after delivery
Retrieval of umbilical cord blood.
-During childbirth
Retrieval of placenta.
-During childbirth
Collection of newborn's and mother's lock of hair.
-During childbirth
Dietetic Patient Outcomes Questionnaires for the mother.
-During pregnancy and after delivery
Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).
-At 2 years of age
Interventions
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Collection of bloods samples for the mother
-During pregnancy, childbirth and after delivery
Retrieval of umbilical cord blood.
-During childbirth
Retrieval of placenta.
-During childbirth
Collection of newborn's and mother's lock of hair.
-During childbirth
Dietetic Patient Outcomes Questionnaires for the mother.
-During pregnancy and after delivery
Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).
-At 2 years of age
Eligibility Criteria
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Inclusion Criteria
* 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
* Underage women
* Woman with a multiple pregnancy
18 Years
65 Years
FEMALE
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Geraldine GASCOIN, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
Locations
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UHAngers
Angers, , France
Countries
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Central Contacts
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Facility Contacts
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Geraldine GASCOIN, Pr
Role: primary
Other Identifiers
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2016-A01546-45
Identifier Type: -
Identifier Source: org_study_id