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

Sleeve Gastrectomy Clinical Trial

Official title: Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin

Status Recruiting

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Pregnancy Complications
• Sleeve Gastrectomy

• NCT number: NCT05977790
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Séverine Ledoux, MD
• Phone: 01 47 60 62 50
• Email: severine.ledoux@aphp.fr
• Status: Recruiting
• Start date: July 10, 2023
• Completion date: July 2025