Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy
时间窗: 18 months
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.
次要结局
- Nutritional factors that may influence birth weight after sleeve gastrectomy(18 months)
- Obstetric factors that may influence birth weight after sleeve gastrectomy(18 months)
- Nutritional factors that may interact with the effect of ghrelin(18 months)
- Obstetric factors that may interact with the effect of ghrelin(18 months)