Nutritional Deficiency in Pregnancy (Disorder)PREGNUTRIBARNCT03469635
Nutritional Status During Pregnancy After Bariatric Surgery
An observational study of Nutritional Deficiency in Pregnancy (Disorder) and Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Background: There is a lack of evidence on whether maternal nutritional deficiencies after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) affect fetal development. The investigators hypothesis is that SG could induce nutritional deficiencies during pregnancy, as RYGB does, because of food restriction. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Nutritional Deficiency in Pregnancy (Disorder), Bariatric Surgery
- What is being tested?
- Nutritional deficiencies in pregnant women after bariatric surgery
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2017
- Phase
- Observational
- 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 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women after bariatric surgery
Who may be able to join
- pregnant women age > 18, who have undergone sleeve gastrectomy or Roux-en-Y gastric bypass and performed at least one nutritional evaluation during the pregnancy
Who cannot join
- twin pregnancy
- pregnant women operated by another procedure
- women who refused that data of nutritional status or delivery were used for the research
About this study
Official title: Impact of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass on Fetal Growth and Relationship With the Nutritional Status of Pregnant Women
Background: There is a lack of evidence on whether maternal nutritional deficiencies after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) affect fetal development. The investigators hypothesis is that SG could induce nutritional deficiencies during pregnancy, as RYGB does, because of food restriction. These nutritional deficiencies may alter fetal growth. Methods: Women with singleton pregnancies who had at least one nutritional evaluation during pregnancy in our institution between 2006 and 2017 were included. The investigators evaluated nutritional deficiencies according to standard and pregnancy-specific norms. They have planned to study the relationships between these parameters and fetal growth. Objectives: To compare maternal nutritional parameters and neonatal outcomes after RYGB and SG and to assess the impact of nutritional alterations on fetal growth.
Read the detailed description
Design: this study is a retrospective observational study, based on a single-centre database established since 2004 at the Louis Mourier Hospital in patients who have undergone bariatric surgery. This study focuses on women who have had at least one nutritional assessment at Louis Mourier Hospital during their pregnancy between 2004 and 2017. Clinical and biological data from the database and the data from delivery collected for usual care will be used retrospectively for this study. Main objective: to compare fetal growth after SG and RYGB. Primary endpoint: measurement of birth weight.
Secondary objectives and endpoints: - to compare fetal growth after SG and RYGB adjusted for gestational age and sex (birth weight Z-score).
- to compare the number of small for gestational age after SG and RYGB (birth weight Z-score <10 th percentile)
- to compare after SG and RYGB nutritional parameters including the following evaluation criteria:
- Before pregnancy: weight and body mass index, weight loss between surgery and early pregnancy
- During pregnancy: weight gain, dietary intake, biological parameters measured in the second trimester of pregnancy, in blood (iron, ferritin, transferrin saturation, calcium, magnesium, albumin, pre-albumin, vitamins A , D, E, C, B1, B6, B9, B12, zinc, selenium, parathyroid hormone, homocysteine, hemoglobin, mean cell volume, hematocrit, blood glucose, triglycerides, cholesterol, insulin) and urine (calcium, urea, creatinine).
- to compare the number of nutritional deficiencies (number of deficiencies for each parameter listed above) after SG and RYGB with standard and pregnancy norms.
- to compare the type of deficiency after SG and RYGB (difference between the 2 types of surgery for each parameter)
- to study the relationship between nutritional parameters and fetal growth after bariatric surgery (correlations between concentrations of nutritional parameters, birth weight and birth weight Z-score)
- to study the relationship between nutritional parameters and fetal growth after each type of surgery (SG and RYGB).
Population studied: pregnant women after bariatric surgery including RYGB and SG. Practical implementation: for women who are referred to our institution during pregnancy, systematic vitamin supplementation is prescribed and then adjusted according to the nutritional dosages performed at least once a trimester. All women benefit from a systematic investigation, which includes a medical consultation, a dietary survey and fasting biological tests according to our routine post-operative evaluation. These data are prospectively collected in a database. They will be used for the study retrospectively. The birth data collected in the medical file at the end of the pregnancy will also be used for the study retrospectively. An oral agreement was obtained from all women for the collection of these data for research and a non opposition form was sended. A questionnaire was sent to women for whom there was missing data concerning their delivery.
- Being tested
- Nutritional deficiencies in pregnant women after bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional deficiencies in pregnant women after bariatric surgeryOther
compare maternal nutritional parameters and neonatal outcomes after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) and to assess the impact of nutritional alterations on fetal growth.
What is being measured
The primary outcome is the main question the study is designed to answer.
birth weight
Measured: at birth
Secondary outcomes (7)
birth weight Z-score
Measured: at birth
number of newborns with birth weight Z-score < 10 th percentile
Measured: at birth
pre pregnancy weight (kg)
Measured: beginning (1st week) and end of pregnancy (39 +/- 4 weeks)
weight gain during pregnancy (kg)
Measured: end of pregnancy (39 +/- 4 weeks)
caloric intake during pregnancy (Kcal/day)
Measured: second trimester of pregnancy (between 3 and 6 months of pregnancy)
protein intake during pregnancy (g/day)
Measured: second trimester of pregnancy (between 3 and 6 months of pregnancy)
number of nutritional deficiencies during pregnancy
nutritional parameters below the low normal value of usual norms
Measured: second trimester of pregnancy (between 3 and 6 months of pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study startJan 2006
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Deficiency in Pregnancy (Disorder)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muriel Coupaye, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469635
- Sponsor's protocol ID
- 2017-033
- Acronym
- PREGNUTRIBAR
- Status last verified
- Dec 2017
- First submitted
- 2 Jan 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass on Fetal Growth and Relationship With the Nutritional Status of Pregnant Women
- ClinicalTrials.gov ID
- NCT03469635
- Acronym / sponsor ID
- PREGNUTRIBAR / 2017-033
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Mar 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.
Background: There is a lack of evidence on whether maternal nutritional deficiencies after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) affect fetal development. The investigators hypothesis is that SG could induce nutritional deficiencies during pregnancy, as RYGB does, because of food restriction. These nutritional deficiencies may alter fetal growth. Methods: Women with singleton pregnancies who had at least one nutritional evaluation during pregnancy in our institution between 2006 and 2017 were included. The investigators evaluated nutritional deficiencies according to standard and pregnancy-specific norms. They have planned to study the relationships between these parameters and fetal growth. Objectives: To compare maternal nutritional parameters and neonatal outcomes after RYGB and SG and to assess the impact of nutritional alterations on fetal growth.
Detailed description
Design: this study is a retrospective observational study, based on a single-centre database established since 2004 at the Louis Mourier Hospital in patients who have undergone bariatric surgery. This study focuses on women who have had at least one nutritional assessment at Louis Mourier Hospital during their pregnancy between 2004 and 2017. Clinical and biological data from the database and the data from delivery collected for usual care will be used retrospectively for this study. Main objective: to compare fetal growth after SG and RYGB. Primary endpoint: measurement of birth weight.
Secondary objectives and endpoints: - to compare fetal growth after SG and RYGB adjusted for gestational age and sex (birth weight Z-score).
- to compare the number of small for gestational age after SG and RYGB (birth weight Z-score <10 th percentile)
- to compare after SG and RYGB nutritional parameters including the following evaluation criteria:
- Before pregnancy: weight and body mass index, weight loss between surgery and early pregnancy
- During pregnancy: weight gain, dietary intake, biological parameters measured in the second trimester of pregnancy, in blood (iron, ferritin, transferrin saturation, calcium, magnesium, albumin, pre-albumin, vitamins A , D, E, C, B1, B6, B9, B12, zinc, selenium, parathyroid hormone, homocysteine, hemoglobin, mean cell volume, hematocrit, blood glucose, triglycerides, cholesterol, insulin) and urine (calcium, urea, creatinine).
- to compare the number of nutritional deficiencies (number of deficiencies for each parameter listed above) after SG and RYGB with standard and pregnancy norms.
- to compare the type of deficiency after SG and RYGB (difference between the 2 types of surgery for each parameter)
- to study the relationship between nutritional parameters and fetal growth after bariatric surgery (correlations between concentrations of nutritional parameters, birth weight and birth weight Z-score)
- to study the relationship between nutritional parameters and fetal growth after each type of surgery (SG and RYGB).
Population studied: pregnant women after bariatric surgery including RYGB and SG. Practical implementation: for women who are referred to our institution during pregnancy, systematic vitamin supplementation is prescribed and then adjusted according to the nutritional dosages performed at least once a trimester. All women benefit from a systematic investigation, which includes a medical consultation, a dietary survey and fasting biological tests according to our routine post-operative evaluation. These data are prospectively collected in a database. They will be used for the study retrospectively. The birth data collected in the medical file at the end of the pregnancy will also be used for the study retrospectively. An oral agreement was obtained from all women for the collection of these data for research and a non opposition form was sended. A questionnaire was sent to women for whom there was missing data concerning their delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women after bariatric surgery
Key inclusion criteria (1 listed)
- pregnant women age > 18, who have undergone sleeve gastrectomy or Roux-en-Y gastric bypass and performed at least one nutritional evaluation during the pregnancy
Key exclusion criteria (3 listed)
- twin pregnancy
- pregnant women operated by another procedure
- women who refused that data of nutritional status or delivery were used for the research
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 |
|---|---|---|
| Nutritional deficiencies in pregnant women after bariatric surgerycompare maternal nutritional parameters and neonatal outcomes after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) and to assess the impact of nutritional alterations on fetal growth. | Other | – |
Primary outcome
birth weight
Time frame: at birth
7 secondary outcomes
birth weight Z-score
Time frame: at birth
number of newborns with birth weight Z-score < 10 th percentile
Time frame: at birth
pre pregnancy weight (kg)
Time frame: beginning (1st week) and end of pregnancy (39 +/- 4 weeks)
weight gain during pregnancy (kg)
Time frame: end of pregnancy (39 +/- 4 weeks)
caloric intake during pregnancy (Kcal/day)
Time frame: second trimester of pregnancy (between 3 and 6 months of pregnancy)
protein intake during pregnancy (g/day)
Time frame: second trimester of pregnancy (between 3 and 6 months of pregnancy)
number of nutritional deficiencies during pregnancy
Time frame: second trimester of pregnancy (between 3 and 6 months of pregnancy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
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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.
Muriel Coupaye, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Deficiency in Pregnancy (Disorder) and Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
birth weight (time frame: at birth). 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 19 Mar 2018.