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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2016

Open Access 01-12-2016 | Study protocol

AURORA: bariatric surgery registration in women of reproductive age - a multicenter prospective cohort study

Authors: Goele Jans, Christophe Matthys, Sarah Bel, Lieveke Ameye, Matthias Lannoo, Bart Van der Schueren, Bruno Dillemans, Luc Lemmens, Jean-Pierre Saey, Yves van Nieuwenhove, Pascale Grandjean, Ben De Becker, Hilde Logghe, Marc Coppens, Kristien Roelens, Anne Loccufier, Johan Verhaeghe, Roland Devlieger

Published in: BMC Pregnancy and Childbirth | Issue 1/2016

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Abstract

Background

The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures, in particular in women of reproductive age. The weight loss induced by the surgery is believed to reverse the negative impact of overweight and obesity on female reproduction, however, research is limited to in particular retrospective cohort studies and a growing number of small case-series and case-(control) studies.

Methods/design

AURORA is a multicenter prospective cohort study. The main objective is to collect long-term data on reproductive outcomes before and after bariatric surgery and in a subsequent pregnancy. Women aged 18–45 years are invited to participate at 4 possible inclusion moments: 1) before surgery, 2) after surgery, 3) before 15 weeks of pregnancy and 4) in the immediate postpartum period (day 3–4). Depending on the time of inclusion, data are collected before surgery (T1), 3 weeks and 3, 6, 12 or x months after surgery (T2-T5) and during the first, second and third trimester of pregnancy (T6-T8), at delivery (T9) and 6 weeks and 6 months after delivery (T10-T11). Online questionnaires are send on the different measuring moments. Data are collected on contraception, menstrual cycle, sexuality, intention of becoming pregnant, diet, physical activity, lifestyle, psycho-social characteristics and dietary supplement intake. Fasting blood samples determine levels of vitamin A, D, E, K, B-1, B-12 and folate, albumin, total protein, coagulation parameters, magnesium, calcium, zinc and glucose. Participants are weighted every measuring moment. Fetal ultrasounds and pregnancy course and complications are reported every trimester of pregnancy. Breastfeeding is recorded and breast milk composition in the postpartum period is studied.

Discussion

AURORA is a multicenter prospective cohort study extensively monitoring women before undergoing bariatric surgery until a subsequent pregnancy and postpartum period.

Trial registration

Retrospectively registered (July 2015 - NCT02515214)
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Metadata
Title
AURORA: bariatric surgery registration in women of reproductive age - a multicenter prospective cohort study
Authors
Goele Jans
Christophe Matthys
Sarah Bel
Lieveke Ameye
Matthias Lannoo
Bart Van der Schueren
Bruno Dillemans
Luc Lemmens
Jean-Pierre Saey
Yves van Nieuwenhove
Pascale Grandjean
Ben De Becker
Hilde Logghe
Marc Coppens
Kristien Roelens
Anne Loccufier
Johan Verhaeghe
Roland Devlieger
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2016
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-016-0992-y

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