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Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin (FG-SLEEVE)

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ClinicalTrials.gov Identifier: NCT05977790
Recruitment Status : Recruiting
First Posted : August 4, 2023
Last Update Posted : August 4, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief 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.

Condition or disease
In Utero Growth Retardation Sleeve Gastrectomy Bariatric Surgery Status Complicating Pregnancy

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
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin
Actual Study Start Date : July 10, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : July 2025
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Nutritional factors that may influence birth weight after sleeve gastrectomy [ Time Frame: 18 months ]

    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.


  2. Obstetric factors that may influence birth weight after sleeve gastrectomy [ Time Frame: 18 months ]

    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


  3. Nutritional factors that may interact with the effect of ghrelin [ Time Frame: 18 months ]

    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.


  4. Obstetric factors that may interact with the effect of ghrelin [ Time Frame: 18 months ]

    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



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977790


Contacts
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Contact: Séverine Ledoux, MD 01 47 60 62 50 severine.ledoux@aphp.fr
Contact: Maude Le Gall maude.le-gall@inserm.fr

Locations
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France
Hopital Louis Mourier Recruiting
Colombes, France, 92025
Contact: Séverine Ledoux, MD    01 47 60 62 50    severine.ledoux@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Séverine Ledoux, MD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05977790    
Other Study ID Numbers: APHP220714
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: August 4, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
sleeve gastrectomy
ghrelin
Additional relevant MeSH terms:
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Fetal Growth Retardation
Pregnancy Complications
Fetal Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Growth Disorders
Pathologic Processes