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

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, 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

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 ).

Keywords: Bariatric surgery; Breast feeding; Contraception; Fertility; Obesity; Pregnancy; Reproduction.

Figures

Fig. 1
Fig. 1
Different sites. = pregnant and non-pregnant subjects. = non-pregnant subjects. = pregnant subjects
Fig. 2
Fig. 2
Scheme of measuring moments. = online data collection. = fasting blood sample. = bariatric surgery. = pregnancy. = birth. = measuring moment. = breast milk samples. T1 (before surgery), T2 (3 weeks after surgery), T3 (3 months after surgery, T4 (6 months after surgery), T5 (12 or X months after surgery), T6 (1st trimester of pregnancy), T7 (2nd trimester of pregnancy), T8 (3rd trimester of pregnancy), T9 (birth), T10 (6 weeks postpartum), T11 (6 months postpartum)

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