ObesityMOBENNNCT02681588
Newborns of Obese Mothers
A study testing Obstetric management in people with Obesity, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
This was a prospective bi-centric study, exposed-unexposed. In an effort to better understand the potential independent effect of maternal obesity on fetal growth, investigators designed a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI < 25 kg/m2) or obese pregnant women (BMI ≥ 30 kg/m2)… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity
- What is being tested?
- Obstetric management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Oct 2013
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - BMI ≥30 kg / m² or between 18.50 and 24.99 kg / m².
- - Pregnant woman coming to the centre before 18 weeks of gestation.
- - Age ≥ 18 and ≤ 40 years
- - Single Pregnancy
- - No constitutional or progressive disease other than obesity: inflammatory disease, epilepsy, pathology psychiatric, tumor...
- - Informed written consent.
Who cannot join
- - Pregnant woman coming to the center after 18 weeks of gestation, BMI <18.5 kg / m² or between 25 and 29.99 Kg / m².
- - Age <18 or> 40 years
- - Multiple pregnancy
- - Presence of a constitutional disease or progressive disease other than obesity.
- - Patients who underwent obesity surgery type "bypass" or gastroplasty
- - Obesity secondary to genetic disorder, intracranial lesions or pituitary radiotherapy
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- - not stabilized endocrine pathology.
- - pregestational diabetes
- - No affiliation to a social security scheme
About this study
Official title: Impact of Maternal Obesity on Fetal Development and Perinatal Events. Analysis of the Determinants of Fetal Growth.
This was a prospective bi-centric study, exposed-unexposed. In an effort to better understand the potential independent effect of maternal obesity on fetal growth, investigators designed a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI < 25 kg/m2) or obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was screened and treated throughout pregnancy.
Read the detailed description
The study population concerned obese pregnant women (BMI ≥ 30 kg / m² before pregnancy) and their newborn and normal weight pregnant women (18.5 ≤IMC <25 kg/m²) and their newborn as control. Inclusion criteria were body mass index (BMI) ≥ 30 kg/m2 or 18.5 ≤ BMI < 25 kg/m2, 18 ≤ age ≤ 40 years, singleton pregnancy. Exclusion criteria were: 25 ≤ BMI <30 kg/m2, age < 18 or > 40 years, multiple pregnancy, first consultation after 18 WG, pregestational diabetes, obesity due to genetic disorder or secondary to intracranial tumor or radiotherapy, bariatric surgery, chronic diseases other than the obesity, inability to converse in French language. The matching criteria for controls were: age ± 5 years, primigravida or multigravida, duration of gestation ± 4 weeks.
The main objective of this project was to assess the independent effect of maternal obesity:
- on the weight and adipose tissue of newborn
- on the function of adipose tissue (production of leptin and adiponectin)
- on fetal growth factors (C-peptide, IGF-1)
- on carbohydrate metabolism of the newborn. Two maternities were involved in the study: Pitié Salpêtrière and Armand Trousseau, in Paris, France. This research was conducted over a 3 years period. The duration of participation of each woman corresponded to the duration of pregnancy care and duration of care for the newborn immediately after birth, usually the length of stay in the maternity.
The only differences compared to the usual care included:
- Additional oral glucose tolerance test at 32 weeks of gestation;
- Determination of fasting blood glucose during late pregnancy
- Maternal blood samples on arrival at the delivery room
- Drawing blood from the umbilical cord after section;
- Skinfold measurement of the newborn within 72 hours of life.
- Conditions
- Obesity
- Being tested
- Obstetric management
- Keywords
- diabetes, obesity, skinfold, newborn
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric managementProcedure or surgery
Screening for gestational diabetes at 32 weeks of gestation, determination of fasting glucose during late pregnancy ; blood samples on arrival at the delivery room ; drawing blood from the umbilical cord after section; skinfold measurement of the newborn within 72 hours of life.
| Study group | Role | What they receive |
|---|---|---|
| Obese group | Experimental | Not described Receives: Procedure: Obstetric management |
| Normal Weight group | Active comparator | Not described Receives: Procedure: Obstetric management |
What is being measured
The primary outcome is the main question the study is designed to answer.
ponderal index measured by a balance
Measured: at birth
skinfold's measure measured by a special clamp
Measured: at birth
birthweight
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681588
- Sponsor's protocol ID
- P081109
- Acronym
- MOBENN
- Status last verified
- Feb 2016
- First submitted
- 10 Feb 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal Obesity on Fetal Development and Perinatal Events. Analysis of the Determinants of Fetal Growth.
- ClinicalTrials.gov ID
- NCT02681588
- Acronym / sponsor ID
- MOBENN / P081109
- Conditions
- Obesity
- Keywords
- diabetes, obesity, skinfold, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Feb 2016 (estimated)
- 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 was a prospective bi-centric study, exposed-unexposed. In an effort to better understand the potential independent effect of maternal obesity on fetal growth, investigators designed a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI < 25 kg/m2) or obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was screened and treated throughout pregnancy.
Detailed description
The study population concerned obese pregnant women (BMI ≥ 30 kg / m² before pregnancy) and their newborn and normal weight pregnant women (18.5 ≤IMC <25 kg/m²) and their newborn as control. Inclusion criteria were body mass index (BMI) ≥ 30 kg/m2 or 18.5 ≤ BMI < 25 kg/m2, 18 ≤ age ≤ 40 years, singleton pregnancy. Exclusion criteria were: 25 ≤ BMI <30 kg/m2, age < 18 or > 40 years, multiple pregnancy, first consultation after 18 WG, pregestational diabetes, obesity due to genetic disorder or secondary to intracranial tumor or radiotherapy, bariatric surgery, chronic diseases other than the obesity, inability to converse in French language. The matching criteria for controls were: age ± 5 years, primigravida or multigravida, duration of gestation ± 4 weeks.
The main objective of this project was to assess the independent effect of maternal obesity:
- on the weight and adipose tissue of newborn
- on the function of adipose tissue (production of leptin and adiponectin)
- on fetal growth factors (C-peptide, IGF-1)
- on carbohydrate metabolism of the newborn. Two maternities were involved in the study: Pitié Salpêtrière and Armand Trousseau, in Paris, France. This research was conducted over a 3 years period. The duration of participation of each woman corresponded to the duration of pregnancy care and duration of care for the newborn immediately after birth, usually the length of stay in the maternity.
The only differences compared to the usual care included:
- Additional oral glucose tolerance test at 32 weeks of gestation;
- Determination of fasting blood glucose during late pregnancy
- Maternal blood samples on arrival at the delivery room
- Drawing blood from the umbilical cord after section;
- Skinfold measurement of the newborn within 72 hours of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese group | Experimental | Procedure: Obstetric management |
| Normal Weight group | Active comparator | Procedure: Obstetric management |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- - BMI ≥30 kg / m² or between 18.50 and 24.99 kg / m².
- - Pregnant woman coming to the centre before 18 weeks of gestation.
- - Age ≥ 18 and ≤ 40 years
- - Single Pregnancy
- - No constitutional or progressive disease other than obesity: inflammatory disease, epilepsy, pathology psychiatric, tumor...
Key exclusion criteria (9 listed)
- - Pregnant woman coming to the center after 18 weeks of gestation, BMI <18.5 kg / m² or between 25 and 29.99 Kg / m².
- - Age <18 or> 40 years
- - Multiple pregnancy
- - Presence of a constitutional disease or progressive disease other than obesity.
- - Patients who underwent obesity surgery type "bypass" or gastroplasty
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 |
|---|---|---|
| Obstetric managementScreening for gestational diabetes at 32 weeks of gestation, determination of fasting glucose during late pregnancy ; blood samples on arrival at the delivery room ; drawing blood from the umbilical cord after section; skinfold measurement of the newborn within 72 hours of life. | Procedure or surgery | Normal Weight group, Obese group |
Primary outcome
ponderal index measured by a balance
Time frame: at birth
skinfold's measure measured by a special clamp
Time frame: at birth
birthweight
Time frame: at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Obstetric management in people with Obesity, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ponderal index measured by a balance (time frame: at birth). 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 6 Apr 2016.