Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977790
Status:
RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-06-19
Brief Title:
Determinant of Fetal Growth Retardation After Sleeve Gastrectomy Involvement of Ghrelin
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Determinant of Fetal Growth Retardation After Sleeve Gastrectomy Involvement of Ghrelin
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FG-SLEEVE
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None