xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977790</url>
    </required_header>
    <id_info>
      <org_study_id>APHP220714</org_study_id>
      <nct_id>NCT05977790</nct_id>
    </id_info>
    <brief_title>Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin</brief_title>
    <acronym>FG-SLEEVE</acronym>
    <official_title>Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to determine, in pregnant women who have undergone sleeve gastrectomy&#xD;
        (SG), whether ghrelin changes could be involved in in utero growth restriction (IUGR) and&#xD;
        whether therefore a correlation between maternal ghrelin levels and birth weight is observed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bariatric surgery (BS) has developed rapidly in recent years and the candidates are&#xD;
        predominantly women of childbearing age. A negative impact on fetal growth (FG), has been&#xD;
        described after BS whose mechanisms are not elucidated. The sleeve gastrectomy (SG), the most&#xD;
        commonly practiced BS technique, is supposed to induce fewer nutritional deficiencies than&#xD;
        gastric bypass. This is why it seems to be the technique of choice for young women, although&#xD;
        the lack of hindsight does not allow recommendations to be made.&#xD;
  &#xD;
        However, latest work showed that birth weight (BW) was affected as much after SG as after&#xD;
        RYGB (Roux-en-Y Gastric Bypass), with 50% of BW Z-score &lt;0 and 19% of small newborns for&#xD;
        gestational age. In addition, only weight gain during pregnancy and maternal protein status&#xD;
        were related to BW, but these parameters explained only 16% and 8% of the variance of the BW&#xD;
        Z-score, respectively, suggesting that other factors are therefore involved.&#xD;
  &#xD;
        Sleeve gastrectomy induces the loss of the majority of gastric cells secreting ghrelin, an&#xD;
        orexigenic hormone involved in the regulation of appetite but also in the pituitary secretion&#xD;
        of growth hormone, which could influence fetal growth, as shown in a model of pregnant rats.&#xD;
        However, no studies have evaluated the link between maternal ghrelin and pregnancy outcome in&#xD;
        women undergoing bariatric surgery.&#xD;
  &#xD;
        The study population will include pregnant women who have undergone bariatric surgery such as&#xD;
        sleeve gastrectomy (which is currently the most frequently performed technique) before&#xD;
        pregnancy, coming to consult between the 3rd and 6th month of pregnancy (2nd trimester) for a&#xD;
        nutritional check-up in a day hospital.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy</measure>
      <time_frame>18 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nutritional factors that may influence birth weight after sleeve gastrectomy</measure>
      <time_frame>18 months</time_frame>
      <description>These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Obstetric factors that may influence birth weight after sleeve gastrectomy</measure>
      <time_frame>18 months</time_frame>
      <description>These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.&#xD;
  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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutritional factors that may interact with the effect of ghrelin</measure>
      <time_frame>18 months</time_frame>
      <description>These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Obstetric factors that may interact with the effect of ghrelin</measure>
      <time_frame>18 months</time_frame>
      <description>These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.&#xD;
  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</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>In Utero Growth Retardation</condition>
    <condition>Sleeve Gastrectomy</condition>
    <condition>Bariatric Surgery Status Complicating Pregnancy</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include pregnant women who have undergone bariatric surgery such&#xD;
          as sleeve gastrectomy before pregnancy, coming to consult between the 3rd and 6th month of&#xD;
          pregnancy (2nd trimester) for a nutritional check-up in a day hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Woman previously operated of sleeve gastrectomy&#xD;
  &#xD;
            -  Pregnant from 3 to 6 months&#xD;
  &#xD;
            -  Having a mono-fetal pregnancy&#xD;
  &#xD;
            -  Coming to consult in day hospital for a nutritional assessment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Twin pregnancy&#xD;
  &#xD;
            -  Identified cause of IUGR apart from those related to sleeve gastrectomy&#xD;
  &#xD;
            -  Woman who has undergone another bariatric surgery technique&#xD;
  &#xD;
            -  Lack of individual information and collection of the consent form&#xD;
  &#xD;
            -  Problems of understanding&#xD;
  &#xD;
            -  Lack of affiliation to a social security scheme or state medical aid&#xD;
  &#xD;
            -  Patient benefiting from a legal protection measure (with guardians or curators)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Séverine Ledoux, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Séverine Ledoux, MD</last_name>
      <phone>01 47 60 62 50</phone>
      <email>severine.ledoux@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maude Le Gall</last_name>
      <email>maude.le-gall@inserm.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hopital Louis Mourier</name>
        <address>
          <city>Colombes</city>
          <zip>92025</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Séverine Ledoux, MD</last_name>
        <phone>01 47 60 62 50</phone>
        <email>severine.ledoux@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>sleeve gastrectomy</keyword>
    <keyword>ghrelin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fetal Growth Retardation</mesh_term>
      <mesh_term>Pregnancy Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977790
  org study id: APHP220714
  nct id: NCT05977790
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy
  time frame: 18 months
  description: 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.
  measure: Nutritional factors that may influence birth weight after sleeve gastrectomy
  time frame: 18 months
  description: 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.
  measure: Obstetric factors that may influence birth weight after sleeve gastrectomy
  time frame: 18 months
  description: 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
  measure: Nutritional factors that may interact with the effect of ghrelin
  time frame: 18 months
  description: 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.
  measure: Obstetric factors that may interact with the effect of ghrelin
  time frame: 18 months
  description: 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
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Séverine Ledoux, MD
  role: Principal Investigator
  affiliation: Assistance Publique - Hôpitaux de Paris
  last name: Séverine Ledoux, MD
  phone: 01 47 60 62 50
  email: severine.ledoux@aphp.fr
  last name: Maude Le Gall
  email: maude.le-gall@inserm.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Fetal Growth Retardation
  mesh term: Pregnancy Complications
  sharing ipd: No