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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)

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ClinicalTrials.gov Identifier: NCT03669731
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Pregnant Women From 20 Amenorrhea Weeks Other: food diary Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Urinary urea 24 hours and food diary
Other: 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.

Experimental: Group 2
Urinary urea 24 hours and food diary
Other: 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.

Experimental: Group 3
Urinary urea 24 hours and food diary
Other: 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.




Primary Outcome Measures :
  1. Protein intake [ Time Frame: an average of 33 weeks ]
    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 :
  1. link between protein consumption in the 3rd trimester and ultrasound data [ Time Frame: an average of 33 weeks ]
    For the 3 groups: results of all obstetrical ultrasound exams performed at 20 AS

  2. nutritional state (nutritional deficiencies) of pregnant women operated on a bariatric surgery using the biological results at T1, T2, T3. [ Time Frame: an average of 7,20 and 33 weeks ]
    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

  3. protein requirements of the pregnant woman according to the 3 groups [ Time Frame: an average of 33 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669731


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Yves BOIRIE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Yves BOIRIE University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03669731    
Other Study ID Numbers: CHU-405
2017-A02350-53 ( Other Identifier: 2017-A02350-53 )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Obesity
Protein
Pregnancy
bariatric surgery
Additional relevant MeSH terms:
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Amenorrhea
Menstruation Disturbances
Pathologic Processes