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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 (BariaProG)

Primary Purpose

Pregnant Women From 20 Amenorrhea Weeks

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
food diary
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pregnant Women From 20 Amenorrhea Weeks focused on measuring Obesity, Protein, Pregnancy, bariatric surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Urinary urea 24 hours and food diary

Urinary urea 24 hours and food diary

Urinary urea 24 hours and food diary

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
August 30, 2018
Last Updated
February 1, 2019
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03669731
Brief Title
Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery
Acronym
BariaProG
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women From 20 Amenorrhea Weeks
Keywords
Obesity, Protein, Pregnancy, bariatric surgery

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Urinary urea 24 hours and food diary
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Urinary urea 24 hours and food diary
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Urinary urea 24 hours and food diary
Intervention Type
Other
Intervention Name(s)
food diary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Protein intake
Description
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.
Time Frame
an average of 33 weeks
Secondary Outcome Measure Information:
Title
link between protein consumption in the 3rd trimester and ultrasound data
Description
For the 3 groups: results of all obstetrical ultrasound exams performed at 20 AS
Time Frame
an average of 33 weeks
Title
nutritional state (nutritional deficiencies) of pregnant women operated on a bariatric surgery using the biological results at T1, T2, T3.
Description
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
Time Frame
an average of 7,20 and 33 weeks
Title
protein requirements of the pregnant woman according to the 3 groups
Description
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.
Time Frame
an average of 33 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves BOIRIE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Yves BOIRIE

12. IPD Sharing Statement

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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

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