跳至主要内容
临床试验/NCT03669731
NCT03669731Unknown不适用

Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年10月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Protein intake

研究概览

简要总结

Adequate equipment for lifelong health is essential to ensure healthy health for fetal development. In France, pregnant women with normal weight have increased protein intake to 0.78-0.95g / kg / day (ANC 2001). And more recently, AFSSA from 2007 proposed a recommended nutritional intake of 0.82-1g / kg / d. An increased requirements in the second and third trimester of 0.25 g / kg / day and 0.46 g / kg / day, respectively, compared with non-pregnancy values. However, the prevalence of the incompatibility remains unknown.

In addition, maternal protein intake is inadequate or excessively associated with both intra-uterine growth retardation and small gestational age weights. Neonatal hypotrophy is also associated with a risk of chronic diseases in adulthood, including cardiovascular disease, type 2 diabetes, insulin resistance, high blood pressure and coronary heart disease.

In obese women or patients undergoing surgery for bariatric surgery, there is currently no recommendation on the recommended protein intake. Or, maternal obesity plays a role in the metabolic development of children and bariatric surgery is associated with a major risk of maternal micronutrient deficiencies and intra-uterine growth retardation.

Prevalence of obesity in France is currently estimated at 17%. Moreover, bariatric surgery is also fast-growing in France with a number of interventions having tripled since 2006.

Thus, a better understanding of maternal food needs and applications throughout pregnancy is needed to improve dietary guidelines and promote fetal, neonatal and long-term health.

详细描述

The main objective is to evaluate the protein intake of the pregnant woman in the 3rd trimester of pregnancy in 3 populations:

  • Women with BMI ≥ 18.5 and <30 kg / m² (group 1)
  • Obese women (BMI ≥ 30 kg / m²) (group 2)
  • Women operated on a bariatric surgery (group 3)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • - Pregnant women from 20 amenorrhea weeks.
  • Women aged at least 18 years old.
  • Women with BMI ≥ 18.5 and <30 kg / m² = Group 1
  • Obese women (BMI ≥ 30 kg / m²) = Group 2
  • Women operated on a bariatric surgery (by-pass, sleeve-gastrectomy, gastric band) = Group 3

排除标准

  • - Women with BMI <18.5 kg / m²
  • Troubles of eating behavior
  • Women with gestational diabetes
  • Medical history of type 1 or type 2 diabetes
  • Multiple pregnancy

结局指标

主要结局

Protein intake

时间窗: an average of 33 weeks

In the 3rd trimester = Weight adjusted protein intake (g / kg / day) ± total protein intake (g / d) and protein proportion of total caloric intake (%) using a 3-day diary.

次要结局

  • nutritional state (nutritional deficiencies) of pregnant women operated on a bariatric surgery using the biological results at T1, T2, T3.(an average of 7,20 and 33 weeks)
  • link between protein consumption in the 3rd trimester and ultrasound data(an average of 33 weeks)
  • protein requirements of the pregnant woman according to the 3 groups(an average of 33 weeks)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验