Nutritional Status During Pregnancy After Bariatric Surgery
Condition: Nutritional Deficiency in Pregnancy (Disorder); Bariatric Surgery
MeSH terms: Malnutrition
Study type: Observational

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. 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:

             1. Before pregnancy: weight and body mass index, weight loss between surgery and early
                pregnancy

             2. 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.
    

Intervention name(s): Nutritional deficiencies in pregnant women after bariatric surgery
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women after bariatric surgery