Pregnant Women From 20 Amenorrhea WeeksBariaProGNCT03669731
Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery
A study testing food diary in people with Pregnant Women From 20 Amenorrhea Weeks, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women From 20 Amenorrhea Weeks
- What is being tested?
- food diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Yves BOIRIE
About this study
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.
Read more
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.
Read the 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
- Being tested
- food diary
- Keywords
- Obesity, Protein, Pregnancy, bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food diaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Urinary urea 24 hours and food diary Receives: Other: food diary |
| Group 2 | Experimental | Urinary urea 24 hours and food diary Receives: Other: food diary |
| Group 3 | Experimental | Urinary urea 24 hours and food diary Receives: Other: food diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: an average of 33 weeks
Secondary outcomes (3)
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
Measured: 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.
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
Measured: an average of 7,20 and 33 weeks
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.
Measured: an average of 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Oct 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women From 20 Amenorrhea WeeksStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves BOIRIE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669731
- Sponsor's protocol ID
- CHU-405
- Other IDs
- 2017-A02350-53
- Acronym
- BariaProG
- Status last verified
- Feb 2019
- First submitted
- 30 Aug 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03669731
- Acronym / sponsor ID
- BariaProG / CHU-405
- Conditions
- Pregnant Women From 20 Amenorrhea Weeks
- Keywords
- Obesity, Protein, Pregnancy, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: food diaryUrinary urea 24 hours and food diary |
| Group 2 | Experimental | Other: food diaryUrinary urea 24 hours and food diary |
| Group 3 | Experimental | Other: food diaryUrinary urea 24 hours and food diary |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food diaryThis 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. | Other | Group 1, Group 2, Group 3 |
Primary outcome
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.
3 secondary outcomes
link between protein consumption in the 3rd trimester and ultrasound data
Time frame: 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.
Time frame: an average of 7,20 and 33 weeks
protein requirements of the pregnant woman according to the 3 groups
Time frame: an average of 33 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves BOIRIE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food diary in people with Pregnant Women From 20 Amenorrhea Weeks, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein intake (time frame: an average of 33 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.