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

NCT ID: NCT03669731

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2020-03-30

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)

Conditions

Pregnant Women From 20 Amenorrhea Weeks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Group 1

Urinary urea 24 hours and food diary

Group Type: EXPERIMENTAL

food diary

Intervention Type: 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 2

Urinary urea 24 hours and food diary

Group Type: EXPERIMENTAL

food diary

Intervention Type: 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 3

Urinary urea 24 hours and food diary

Group Type: EXPERIMENTAL

food diary

Intervention Type: 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.

Interventions

food diary

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves BOIRIE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

drci@chu-clermontferrand.fr

04 73 75 49 63

Facility Contacts

Lise LACLAUTRE

Role: primary

drci@chu-clermontferrand.fr

04 73 75 49 63

Other Identifiers

2017-A02350-53

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-405

Identifier Type: -

Identifier Source: org_study_id