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

NCT03669731 | Unknown

• 2 other identifiers: CHU-4052017-A02350-53
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant Women From 20 Amenorrhea Weeks

Keywords

Obesity; Protein; Pregnancy; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• link between protein consumption in the 3rd trimester and ultrasound data

  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.

  an average of 7,20 and 33 weeks

• protein requirements of the pregnant woman according to the 3 groups

  an average of 33 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

Urinary urea 24 hours and food diary

Other: food diary

Group 2

EXPERIMENTAL

Urinary urea 24 hours and food diary

Other: food diary

Group 3

EXPERIMENTAL

Urinary urea 24 hours and food diary

Other: food diary

Interventions

food diary OTHER

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.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Diet Records

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Records; Organization and Administration; Health Services Administration

Study Officials

• Yves BOIRIE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

04 73 75 49 63; drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 13, 2018
• Study Start: October 10, 2018
• Primary Completion: June 30, 2019
• Study Completion: March 30, 2020
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

FR (1)