In Utero Growth RetardationFG-SLEEVENCT05977790
Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin
An observational study of In Utero Growth Retardation and Sleeve Gastrectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to determine, in pregnant women who have undergone sleeve gastrectomy (SG), whether ghrelin changes could be involved in in utero growth restriction (IUGR) and whether therefore a correlation between maternal ghrelin levels and birth weight is observed. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- In Utero Growth Retardation, Sleeve Gastrectomy, Bariatric Surgery Status Complicating Pregnancy
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2023to Jul 2025
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include pregnant women who have undergone bariatric surgery such as sleeve gastrectomy before pregnancy, coming to consult between the 3rd and 6th month of pregnancy (2nd trimester) for a nutritional check-up in a day hospital.
Who may be able to join
- Woman previously operated of sleeve gastrectomy
- Pregnant from 3 to 6 months
- Having a mono-fetal pregnancy
- Coming to consult in day hospital for a nutritional assessment
Who cannot join
- Twin pregnancy
- Identified cause of IUGR apart from those related to sleeve gastrectomy
- Woman who has undergone another bariatric surgery technique
- Lack of individual information and collection of the consent form
- Problems of understanding
- Lack of affiliation to a social security scheme or state medical aid
- Patient benefiting from a legal protection measure (with guardians or curators)
Trial locations and contacts
1 site in 1 country.
Maude Le Gall contact
France1 site, 1 recruiting
- Recruiting
Hopital Louis Mourier
Colombes, 92025
Séverine Ledoux, MD, 01 47 60 62 50, severine.ledoux@aphp.fr
About this study
The aim of the study is to determine, in pregnant women who have undergone sleeve gastrectomy (SG), whether ghrelin changes could be involved in in utero growth restriction (IUGR) and whether therefore a correlation between maternal ghrelin levels and birth weight is observed.
Read the detailed description
Bariatric surgery (BS) has developed rapidly in recent years and the candidates are predominantly women of childbearing age. A negative impact on fetal growth (FG), has been described after BS whose mechanisms are not elucidated. The sleeve gastrectomy (SG), the most commonly practiced BS technique, is supposed to induce fewer nutritional deficiencies than gastric bypass. This is why it seems to be the technique of choice for young women, although the lack of hindsight does not allow recommendations to be made.
However, latest work showed that birth weight (BW) was affected as much after SG as after RYGB (Roux-en-Y Gastric Bypass), with 50% of BW Z-score <0 and 19% of small newborns for gestational age. In addition, only weight gain during pregnancy and maternal protein status were related to BW, but these parameters explained only 16% and 8% of the variance of the BW Z-score, respectively, suggesting that other factors are therefore involved.
Sleeve gastrectomy induces the loss of the majority of gastric cells secreting ghrelin, an orexigenic hormone involved in the regulation of appetite but also in the pituitary secretion of growth hormone, which could influence fetal growth, as shown in a model of pregnant rats. However, no studies have evaluated the link between maternal ghrelin and pregnancy outcome in women undergoing bariatric surgery.
The study population will include pregnant women who have undergone bariatric surgery such as sleeve gastrectomy (which is currently the most frequently performed technique) before pregnancy, coming to consult between the 3rd and 6th month of pregnancy (2nd trimester) for a nutritional check-up in a day hospital.
- Conditions
- In Utero Growth Retardation, Sleeve Gastrectomy, Bariatric Surgery Status Complicating Pregnancy
- Keywords
- sleeve gastrectomy, ghrelin
- Medical subject headings
- Fetal Growth Retardation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy
Fasting blood ghrelin level measured in plasma by radioimmunoassay technique in the second trimester of pregnancy. The dosages will be carried out deferred after freezing at -80 ° C in a laboratory, in order to be able to dose all the samples at the same time and limit the variability of the results.
Measured: 18 months
Secondary outcomes (4)
Nutritional factors that may influence birth weight after sleeve gastrectomy
These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.
Parameters collected : parity, tobacco, alcohol, current treatment, vitamin supplementation, weight and BMI before sleeve, weight loss after sleeve, weight gain during the visit, caloric intake during the visit, number and type of nutritional deficiencies, total weight gain during pregnancy.
Measured: 18 months
Obstetric factors that may influence birth weight after sleeve gastrectomy
These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.
Parameters collected : term at time of analysis, time since sleeve, term of pregnancy at birth, sex of child, PN Z-score, complications of pregnancy or birth
Measured: 18 months
Nutritional factors that may interact with the effect of ghrelin
These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.
Parameters collected : parity, tobacco, alcohol, current treatment, vitamin supplementation, weight and BMI before sleeve, weight loss after sleeve, weight gain during the visit, caloric intake during the visit, number and type of nutritional deficiencies, total weight gain during pregnancy.
Measured: 18 months
Obstetric factors that may interact with the effect of ghrelin
These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.
Parameters collected : term at time of analysis, time since sleeve, term of pregnancy at birth, sex of child, PN Z-score, complications of pregnancy or birth
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start10 Jul 2023
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Utero Growth RetardationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Séverine Ledoux, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977790
- Sponsor's protocol ID
- APHP220714
- Acronym
- FG-SLEEVE
- Status last verified
- Aug 2023
- First submitted
- 19 Jun 2023
- Last updated
- 4 Aug 2023
- 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 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin
- ClinicalTrials.gov ID
- NCT05977790
- Acronym / sponsor ID
- FG-SLEEVE / APHP220714
- Conditions
- In Utero Growth Retardation, Sleeve Gastrectomy, Bariatric Surgery Status Complicating Pregnancy
- Keywords
- sleeve gastrectomy, ghrelin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Aug 2023 (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.
The aim of the study is to determine, in pregnant women who have undergone sleeve gastrectomy (SG), whether ghrelin changes could be involved in in utero growth restriction (IUGR) and whether therefore a correlation between maternal ghrelin levels and birth weight is observed.
Detailed description
Bariatric surgery (BS) has developed rapidly in recent years and the candidates are predominantly women of childbearing age. A negative impact on fetal growth (FG), has been described after BS whose mechanisms are not elucidated. The sleeve gastrectomy (SG), the most commonly practiced BS technique, is supposed to induce fewer nutritional deficiencies than gastric bypass. This is why it seems to be the technique of choice for young women, although the lack of hindsight does not allow recommendations to be made.
However, latest work showed that birth weight (BW) was affected as much after SG as after RYGB (Roux-en-Y Gastric Bypass), with 50% of BW Z-score <0 and 19% of small newborns for gestational age. In addition, only weight gain during pregnancy and maternal protein status were related to BW, but these parameters explained only 16% and 8% of the variance of the BW Z-score, respectively, suggesting that other factors are therefore involved.
Sleeve gastrectomy induces the loss of the majority of gastric cells secreting ghrelin, an orexigenic hormone involved in the regulation of appetite but also in the pituitary secretion of growth hormone, which could influence fetal growth, as shown in a model of pregnant rats. However, no studies have evaluated the link between maternal ghrelin and pregnancy outcome in women undergoing bariatric surgery.
The study population will include pregnant women who have undergone bariatric surgery such as sleeve gastrectomy (which is currently the most frequently performed technique) before pregnancy, coming to consult between the 3rd and 6th month of pregnancy (2nd trimester) for a nutritional check-up in a day hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pregnant women who have undergone bariatric surgery such as sleeve gastrectomy before pregnancy, coming to consult between the 3rd and 6th month of pregnancy (2nd trimester) for a nutritional check-up in a day hospital.
Key inclusion criteria (4 listed)
- Woman previously operated of sleeve gastrectomy
- Pregnant from 3 to 6 months
- Having a mono-fetal pregnancy
- Coming to consult in day hospital for a nutritional assessment
Key exclusion criteria (7 listed)
- Twin pregnancy
- Identified cause of IUGR apart from those related to sleeve gastrectomy
- Woman who has undergone another bariatric surgery technique
- Lack of individual information and collection of the consent form
- Problems of understanding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy
Time frame: 18 months
Fasting blood ghrelin level measured in plasma by radioimmunoassay technique in the second trimester of pregnancy. The dosages will be carried out deferred after freezing at -80 ° C in a laboratory, in order to be able to dose all the samples at the same time and limit the variability of the results.
4 secondary outcomes
Nutritional factors that may influence birth weight after sleeve gastrectomy
Time frame: 18 months
Obstetric factors that may influence birth weight after sleeve gastrectomy
Time frame: 18 months
Nutritional factors that may interact with the effect of ghrelin
Time frame: 18 months
Obstetric factors that may interact with the effect of ghrelin
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- 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.
Maude Le Gall contact
Séverine Ledoux, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Utero Growth Retardation and Sleeve Gastrectomy, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 7 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 4 Aug 2023. 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 Séverine Ledoux, MD (01 47 60 62 50, severine.ledoux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy (time frame: 18 months). 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 4 Aug 2023.