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

Not Applicable
Conditions
Pregnant Women From 20 Amenorrhea Weeks
Interventions
Other: food diary
Registration Number
NCT03669731
Lead Sponsor
University Hospital, Clermont-Ferrand
Brief Summary

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.

Detailed Description

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)

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
120
Inclusion Criteria
    • 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
Exclusion Criteria
    • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 1food diaryUrinary urea 24 hours and food diary
Group 2food diaryUrinary urea 24 hours and food diary
Group 3food diaryUrinary urea 24 hours and food diary
Primary Outcome Measures
NameTimeMethod
Protein intakean 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.

Secondary Outcome Measures
NameTimeMethod
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

Retrospective collection of the results of the biological assessment prescribed in the three trimesters (including vitamins, trace elements) for the group of women operated on bariatric surgery

link between protein consumption in the 3rd trimester and ultrasound dataan average of 33 weeks

For the 3 groups: results of all obstetrical ultrasound exams performed at 20 AS

protein requirements of the pregnant woman according to the 3 groupsan average of 33 weeks

The protein requirement of the patients is determined from a statistical analysis called straight line of linear regression between nitrogen balance and protein intake (g / kg / day body weight) for the population. It corresponds, according to this line, to the value for which the nitrogen balance is zero.

Trial Locations

Locations (1)

Chu Clermont-Ferrand

🇫🇷

Clermont-Ferrand, France

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