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Clinical Trials/NCT03669731
NCT03669731
Unknown
Not Applicable

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-Ferrand1 site in 1 country120 target enrollmentOctober 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnant Women From 20 Amenorrhea Weeks
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
120
Locations
1
Primary Endpoint
Protein intake
Last Updated
7 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
October 10, 2018
End Date
March 30, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Protein intake

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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