Bariatric Surgery Clinical Trial
— PREGNUTRIBAROfficial title:
Impact of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass on Fetal Growth and Relationship With the Nutritional Status of Pregnant Women
Verified date | December 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | December 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - twin pregnancy - pregnant women operated by another procedure - women who refused that data of nutritional status or delivery were used for the research |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | birth weight | at birth | ||
Secondary | birth weight Z-score | at birth | ||
Secondary | number of newborns with birth weight Z-score < 10 th percentile | at birth | ||
Secondary | pre pregnancy weight (kg) | beginning (1st week) and end of pregnancy (39 +/- 4 weeks) | ||
Secondary | weight gain during pregnancy (kg) | end of pregnancy (39 +/- 4 weeks) | ||
Secondary | caloric intake during pregnancy (Kcal/day) | second trimester of pregnancy (between 3 and 6 months of pregnancy) | ||
Secondary | protein intake during pregnancy (g/day) | second trimester of pregnancy (between 3 and 6 months of pregnancy) | ||
Secondary | number of nutritional deficiencies during pregnancy | nutritional parameters below the low normal value of usual norms | second trimester of pregnancy (between 3 and 6 months of pregnancy) |
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