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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Pregnant Women From 20 Amenorrhea Weeks

Intervention / Treatment
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* Other: food diary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Urinary urea 24 hours and food diary | Other: food diary<br>* This food diary is to be completed by the patient in the 3rd trimester of pregnancy, on 3 consecutive days and if possible including a weekend day. Finally, the investigator also prescribes a biological analysis: a urinary urea from a 24h diuresis to be collected in the 3rd trimester in a dedicated collector and given that same day.<br>|
| Experimental: Group 2<br>Urinary urea 24 hours and food diary | Other: food diary<br>* This food diary is to be completed by the patient in the 3rd trimester of pregnancy, on 3 consecutive days and if possible including a weekend day. Finally, the investigator also prescribes a biological analysis: a urinary urea from a 24h diuresis to be collected in the 3rd trimester in a dedicated collector and given that same day.<br>|
| Experimental: Group 3<br>Urinary urea 24 hours and food diary | Other: food diary<br>* This food diary is to be completed by the patient in the 3rd trimester of pregnancy, on 3 consecutive days and if possible including a weekend day. Finally, the investigator also prescribes a biological analysis: a urinary urea from a 24h diuresis to be collected in the 3rd trimester in a dedicated collector and given that same day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein intake | 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. | an average of 33 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| link between protein consumption in the 3rd trimester and ultrasound data | For the 3 groups: results of all obstetrical ultrasound exams performed at 20 AS | an average of 33 weeks | 
| nutritional state (nutritional deficiencies) of pregnant women operated on a bariatric surgery using the biological results at T1, T2, T3. | 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 | an average of 7,20 and 33 weeks | 
| protein requirements of the pregnant woman according to the 3 groups | 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. | an average of 33 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Protein, Pregnancy, bariatric surgery