Maternal ObesitySMOOTHIENCT03084120
Effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child
A study testing Collection of bloods samples for the mother, Retrieval of umbilical cord blood. and Retrieval of placenta. in people with Maternal Obesity, run by University Hospital, Angers at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Maternal Obesity
- What is being tested?
- Collection of bloods samples for the mother, Retrieval of umbilical cord blood. and Retrieval of placenta.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2017to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- For every arms :
- Underage women
- Woman with a multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Maternal Obesity
- Being tested
- 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.
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of bloods samples for the motherOther
-During pregnancy, childbirth and after delivery
Retrieval of umbilical cord blood.Other
-During childbirth
Retrieval of placenta.Other
-During childbirth
Collection of newborn's and mother's lock of hair.Other
-During childbirth
Dietetic Patient Outcomes Questionnaires for the mother.Other
-During pregnancy and after delivery
Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).Other
-At 2 years of age
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Collection of bloods samples for the mother; Other: 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). Receives: Other: Collection of bloods samples for the mother; Other: 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). |
| 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). Receives: Other: Collection of bloods samples for the mother; Other: 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). |
| 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). Receives: Other: Collection of bloods samples for the mother; Other: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Born measurement (weight) expressed in z-score.
Z-scores are "pure numbers" (have no units of measurement attached to them).
Measured: At the childbirth
Born measurement (height) expressed in z-score.
Z-scores are "pure numbers" (have no units of measurement attached to them).
Measured: At the childbirth
Born measurement (cranial perimeter) expressed in z-score.
Z-scores are "pure numbers" (have no units of measurement attached to them).
Measured: At the childbirth.
Secondary outcomes (9)
Modification of auxological data (weight) at the age of 2.
Weight expressed in kilograms.
Measured: At the age of 2.
Modification of auxological data (height) at the age of 2.
Height expressed in centimeters.
Measured: At the age of 2.
Modification of auxological data (cranial perimeter) at the age of 2.
Cranial perimeter expressed in centimeters.
Measured: At the age of 2.
Modification of auxological data (BMI (Body Mass Index)) at the age of 2.
BMI (Body Mass Index) expressed in kg/m².
Measured: At the age of 2.
Modification of auxological data (speed of growth expressed) at the age of 2.
Speed of growth expressed in centimeters per year.
Measured: At the age of 2.
Neurodevelopmental modifications at the age of 2.
Parental questionnaire : Ages \& Stages Questionnaires (ASQ).
Measured: At the age of 2.
Modifications of eating habits at the age of 2.
Parental questionnaire : Child Feeding Questionnaire (CFQ).
Measured: At the age of 2.
Vitamin dosages and micronutrients in the blood of cordon.
Dosages.
Measured: At the childbirth.
Vitamin dosages and maternal micronutrients in the first, second, third quarter of the pregnancy, at the childbirth and in 2 months after delivery.
Dosages.
Measured: First, second, third quarter of the pregnancy, at the childbirth and in 2 months after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start10 May 2017
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- a prospective monocentric study, not therapeutic, and physiopathological
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Geraldine GASCOIN, Pr, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084120
- Sponsor's protocol ID
- 2016-A01546-45
- Acronym
- SMOOTHIE
- Status last verified
- Nov 2017
- First submitted
- 20 Feb 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child
- ClinicalTrials.gov ID
- NCT03084120
- Acronym / sponsor ID
- SMOOTHIE / 2016-A01546-45
- Conditions
- Maternal Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 May 2017 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- a prospective monocentric study, not therapeutic, and physiopathological
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass surgery | Other | Other: Collection of bloods samples for the mother, Other: 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).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). |
| Reference group | Other | Other: Collection of bloods samples for the mother, Other: 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).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 | Other: Collection of bloods samples for the mother, Other: 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).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 | Other: Collection of bloods samples for the mother, Other: 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).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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For "Gastric Bypass Surgery" arm :
- For "Reference group" arm :
- For "Overweight" arm :
- For "Obesity " arm :
Key exclusion criteria (3 listed)
- For every arms :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of bloods samples for the mother-During pregnancy, childbirth and after delivery | Other | Gastric bypass surgery, Obesity, Overweight, Reference group |
| Retrieval of umbilical cord blood.-During childbirth | Other | Gastric bypass surgery, Obesity, Overweight, Reference group |
| Retrieval of placenta.-During childbirth | Other | Gastric bypass surgery, Obesity, Overweight, Reference group |
| Collection of newborn's and mother's lock of hair.-During childbirth | Other | Gastric bypass surgery, Obesity, Overweight, Reference group |
| Dietetic Patient Outcomes Questionnaires for the mother.-During pregnancy and after delivery | Other | Gastric bypass surgery, Obesity, Overweight, Reference group |
| Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).-At 2 years of age | Other | Gastric bypass surgery, Obesity, Overweight, Reference group |
Primary outcome
Born measurement (weight) expressed in z-score.
Time frame: At the childbirth
Z-scores are "pure numbers" (have no units of measurement attached to them).
Born measurement (height) expressed in z-score.
Time frame: At the childbirth
Z-scores are "pure numbers" (have no units of measurement attached to them).
Born measurement (cranial perimeter) expressed in z-score.
Time frame: At the childbirth.
Z-scores are "pure numbers" (have no units of measurement attached to them).
9 secondary outcomes
Modification of auxological data (weight) at the age of 2.
Time frame: At the age of 2.
Modification of auxological data (height) at the age of 2.
Time frame: At the age of 2.
Modification of auxological data (cranial perimeter) at the age of 2.
Time frame: At the age of 2.
Modification of auxological data (BMI (Body Mass Index)) at the age of 2.
Time frame: At the age of 2.
Modification of auxological data (speed of growth expressed) at the age of 2.
Time frame: At the age of 2.
Neurodevelopmental modifications at the age of 2.
Time frame: At the age of 2.
Modifications of eating habits at the age of 2.
Time frame: At the age of 2.
Vitamin dosages and micronutrients in the blood of cordon.
Time frame: At the childbirth.
Vitamin dosages and maternal micronutrients in the first, second, third quarter of the pregnancy, at the childbirth and in 2 months after delivery.
Time frame: First, second, third quarter of the pregnancy, at the childbirth and in 2 months after delivery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine GASCOIN, Pr principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of bloods samples for the mother, Retrieval of umbilical cord blood. and Retrieval of placenta. in people with Maternal Obesity, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elsa BERARDI (+33 2 41 35 61 79, elberardi@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Born measurement (weight) expressed in z-score. (time frame: At the childbirth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.