Clinical trial NCT05977790: Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin
Official title: Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: In Utero Growth Retardation
Sleeve Gastrectomy
Bariatric Surgery Status Complicating Pregnancy
Keywords: sleeve gastrectomy
ghrelin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy
timeFrame: 18 months
Secondary outcomes:
measure: Nutritional factors that may influence birth weight after sleeve gastrectomy
timeFrame: 18 months
measure: Obstetric factors that may influence birth weight after sleeve gastrectomy
timeFrame: 18 months
measure: Nutritional factors that may interact with the effect of ghrelin
timeFrame: 18 months
measure: Obstetric factors that may interact with the effect of ghrelin
timeFrame: 18 months
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hopital Louis Mourier
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Séverine Ledoux, MD
role: PRINCIPAL_INVESTIGATOR
References: