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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

240

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.2 years study duration

First Submitted

Initial submission to the registry

February 20, 2017

Completed

28 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed

2 months until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed

Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

5.2 years

First QC Date

February 20, 2017

Last Update Submit

November 29, 2017

Conditions

Maternal Obesity

Outcome Measures

Primary Outcomes (3)

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 Outcomes (9)

Modification of auxological data (weight) at the age of 2.
At the age of 2.
Modification of auxological data (height) at the age of 2.
At the age of 2.
Modification of auxological data (cranial perimeter) at the age of 2.
At the age of 2.
Modification of auxological data (BMI (Body Mass Index)) at the age of 2.
At the age of 2.
Modification of auxological data (speed of growth expressed) at the age of 2.
At the age of 2.
+4 more secondary outcomes

Study Arms (4)

Gastric bypass surgery

OTHER

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 motherOther: 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).

Reference group

OTHER

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).

Overweight

OTHER

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).

Obesity

OTHER

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).