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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Pregnant Women From 20 Amenorrhea Weeks

Treatments: Other: food diary

Study type: Interventional

Funder types: Other

Identifiers

NCT03669731

2017-A02350-53 (Other Identifier)

CHU-405

Details and patient eligibility

About

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.

Full 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)

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Group 1

Experimental group

Description:

Urinary urea 24 hours and food diary

Treatment:

Other: food diary

Group 2

Experimental group

Description:

Urinary urea 24 hours and food diary

Treatment:

Other: food diary

Group 3

Experimental group

Description:

Urinary urea 24 hours and food diary

Treatment:

Other: food diary