Clinical trial NCT03669731: Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery
Official title: Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Women From 20 Amenorrhea Weeks
Keywords: Obesity
Protein
Pregnancy
bariatric surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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)

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

Primary outcomes:
measure: Protein intake
timeFrame: an average of 33 weeks
Secondary outcomes:
measure: link between protein consumption in the 3rd trimester and ultrasound data
timeFrame: an average of 33 weeks
measure: nutritional state (nutritional deficiencies) of pregnant women operated on a bariatric surgery using the biological results at T1, T2, T3.
timeFrame: an average of 7,20 and 33 weeks
measure: protein requirements of the pregnant woman according to the 3 groups
timeFrame: an average of 33 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Yves BOIRIE
role: PRINCIPAL_INVESTIGATOR
References: