Impact of Bariatric surgery on EmbrYONic, fetal and placental Development (BEYOND): protocol for a prospective cohort study embedded in the Rotterdam periconceptional cohort.

ABSTRACT

INTRODUCTION: The worldwide obesity epidemic has resulted in a rise of bariatric surgery in women of reproductive age, which can lead to 'iatrogenic undernutrition'. Long-lasting undernutrition can affect maternal health, pregnancy outcomes and offspring. We hypothesise that embryonic and placental growth are impaired in pregnancies after bariatric surgery due to the changed nutritional and microbiome dynamics. Therefore, our aim is to conduct the Bariatrics and EmbrYONic Development (BEYOND) study to investigate parameters of maternal nutritional and health status after bariatric surgery, both periconceptionally and during pregnancy, particularly concentrating on embryonic and fetal growth trajectories as well as placental development. METHODS AND ANALYSIS: We designed a single-centre prospective, observational cohort, which investigates the iatrogenic nutritional and health status of women after bariatric surgery, periconceptionally and during pregnancy. The BEYOND study is embedded in the Rotterdam Periconceptional Cohort, a tertiary hospital-based birth cohort study. Eligible participants are women planning pregnancy or <12+0 weeks pregnant, ≥18 and ≤45 years of age, who have undergone bariatric surgery (cases) or without prior bariatric surgery (controls) and their male partners. Medical charts will be reviewed and questionnaires regarding general health, lifestyle and food intake will be collected. Moreover, we will perform serial three-dimensional ultrasounds to assess embryonic growth and placental development and two-dimensional ultrasounds for fetal growth assessment. The microbiome, including the virome, and blood samples will be sampled during the preconception period and in each trimester. Multivariable linear mixed model analyses will be used to assess the associations between bariatric surgery and pregnancy outcomes. ETHICS AND DISSEMINATION This proposal was approved by the Medical Ethics Committee from the Erasmus MC, Rotterdam, The Netherlands. Study results will be submitted for publication in high-impact journals, presented at scientific conferences, implemented into guidelines and communicated through the Erasmus MC and collaborating partners. TRIAL REGISTRATION NUMBER NL8217 (www.trialregister.nl).