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

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Status Complicating Pregnancy; Sleeve Gastrectomy; In Utero Growth Retardation

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Séverine Ledoux, MD; Phone Number: 01 47 60 62 50; Email: severine.ledoux@aphp.fr
• Study Contact Backup: Name: Maude Le Gall; Email: maude.le-gall@inserm.fr

Study Locations

• France
  • Colombes, France, 92025
    • Recruiting
    • Hopital Louis Mourier
    • Contact: Séverine Ledoux, MD; Phone Number: 01 47 60 62 50; Email: severine.ledoux@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	18 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Séverine Ledoux, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: ghrelin; sleeve gastrectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Growth Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Growth Retardation; Pregnancy Complications
• Other Study ID Numbers: APHP220714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No