Pregnant Women From 20 Amenorrhea Weeks Clinical Trial
— BariaProGOfficial title:
Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | March 30, 2020 |
| Est. primary completion date | June 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |