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

BMC Pregnancy and Childbirth

Study Protocol

Bruno Dillemans¹  Luc Lemmens²  Matthias Lannoo³  Christophe Matthys⁴  Bart Van der Schueren⁴  Goele Jans⁵  Lieveke Ameye⁵  Johan Verhaeghe⁶  Roland Devlieger⁷  Yves van Nieuwenhove⁸  Pascale Grandjean⁹  Kristien Roelens^1,10  Anne Loccufier^1,11  Hilde Logghe^1,12  Marc Coppens^1,13  Ben De Becker^1,14  Jean-Pierre Saey^1,15  Sarah Bel^1,16 

[1] Department of Abdominal Surgery, St-Jan Hospital Bruges, Ruddershove 10, 8000, Bruges, Belgium;Department of Abdominal Surgery, St-Nikolaas Hospital, Moerlandstraat 1, 9100, St-Niklaas, Belgium;Department of Clinical and Experimental Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Abdominal Surgery, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Clinical and Experimental Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Endocrinology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Obstetrics and Gynecology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Obstetrics, Gynecology and Reproduction, St-Augustinus Hospital Wilrijk, Oosterveldlaan 24, 2610, Wilrijk, Belgium;Department of Obstetrics and Gynecology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Gastrointestinal Surgery, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium;Department of Obstetrics and Gynecology, CHR Mons Hainaut, 5 avenue Baudouin de Constantinople, 7000, Mons, Belgium;Department of Obstetrics and Gynecology, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium;Department of Obstetrics and Gynecology, St-Jan Hospital Bruges, Ruddershove 10, 8000, Bruges, Belgium;Department of Obstetrics and Gynecology, St-Lucas Hospital Bruges, St-Lucaslaan 29, 8310, Bruges, Belgium;Department of Obstetrics and Gynecology, ZNA Middelheim, Lindendreef 1, 2020, Antwerp, Belgium;Department of Obstetrics, Gynecology and Reproduction, St-Augustinus Hospital Wilrijk, Oosterveldlaan 24, 2610, Wilrijk, Belgium;Medicosurgical unit for metabolic diseases, CHR Mons Hainaut, 5 avenue Baudouin de Constantinople, 7000, Mons, Belgium;Scientific Institute of Public Health, Department of Public Health and Surveillance, Unit Surveys, Lifestyle and Chronic Diseases, Juliette Wytsmanstraat 14, 1050, Brussels, Belgium;

关键词: Obesity;    Bariatric surgery;    Reproduction;    Fertility;    Contraception;    Pregnancy;    Breast feeding;   

DOI  :  10.1186/s12884-016-0992-y

 received in 2015-08-25, accepted in 2016-07-19,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe 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/designAURORA 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.DiscussionAURORA is a multicenter prospective cohort study extensively monitoring women before undergoing bariatric surgery until a subsequent pregnancy and postpartum period.Trial registrationRetrospectively registered (July 2015 - NCT02515214)

【 授权许可】

CC BY   
© The Author(s). 2016