Price Sarah, Nankervis Alison, Permezel Michael, Prendergast Luke, Sumithran Priya, Proietto Joseph
Department of Medicine, University of Melbourne, Heidelberg Repatriation Hospital, Waterdale Rd., Heidelberg, VIC, 3081, Australia.
Diabetes Service, University of Melbourne, Royal Women's Hospital, Flemington Rd., Parkville, VIC, 3050, Australia.
Trials. 2018 Apr 24;19(1):248. doi: 10.1186/s13063-018-2615-6.
Current guidelines for the management of obesity in women planning pregnancy suggest lifestyle modification before conception. However, there is little evidence that lifestyle modification alters pregnancy outcomes. Bariatric surgery results in significant weight loss. This appears to reduce the risk of adverse pregnancy outcomes for the mother but may increase the risk of adverse outcomes for the infant. In order to reduce the risks of obesity-related adverse pregnancy outcomes for both mother and offspring, alternative approaches to the management of obesity in women planning pregnancy are needed.
METHODS/DESIGN: This study, a two-arm, parallel group, randomized control trial, will be conducted at the Metabolic Disorders Centre, University of Melbourne. This trial will recruit 164 women aged 18-38 years with a body mass index of 30-55 kg/m who plan to conceive in the next 6-12 months. Women will be randomized to one of two 12-week interventions (Group A and Group B). Group A will aim for modest weight loss (MWL; ≤ 3% body weight) using a hypocaloric diet. Group B will aim for substantial weight loss (SWL; 10-15% body weight) using a modified very low energy diet (VLED) program. All participants will be asked to comply with National Health and Medical Research Council (NHMRC) guidelines for exercise and will be provided with standard pre-pregnancy advice according to Royal Australian and New Zealand College of Obstetrics and Gynaecology guidelines. All participants will then be observed for the subsequent 12 months. If pregnancy occurs within the 12-month follow-up period, data on weight and metabolic status of the mother, and pregnancy outcomes of mother and offspring will be recorded. The primary outcome is maternal fasting plasma glucose at 26-28 weeks' gestation, given that this is known to correlate with pregnancy outcomes. Time to conception, live birth rate, gestational weight gain, and a composite of adverse pregnancy outcomes for mother and baby will comprise the secondary outcomes.
There is increasing emphasis on obese women losing weight before conception. To date, no randomized controlled trial has demonstrated an effective means of weight loss that results in improved pregnancy outcomes for both mother and baby. This study intends to determine if substantial pre-conception weight loss, achieved using a VLED, improves pregnancy outcomes for mother and baby when compared with standard care. This research will potentially change clinical care of an obese woman planning pregnancy.
ANZCTR, 12,614,001,160,628 . Registered on 5 November 2014.
当前针对计划怀孕的肥胖女性的管理指南建议在受孕前进行生活方式调整。然而，几乎没有证据表明生活方式调整能改变妊娠结局。减肥手术可显著减轻体重。这似乎能降低母亲不良妊娠结局的风险，但可能会增加婴儿出现不良结局的风险。为了降低肥胖相关的母亲和后代不良妊娠结局的风险，需要采用其他方法来管理计划怀孕的肥胖女性。
方法/设计：本研究是一项双臂、平行组随机对照试验，将在墨尔本大学代谢紊乱中心进行。该试验将招募164名年龄在18至38岁、体重指数为30至55kg/m²且计划在未来6至12个月内受孕的女性。女性将被随机分配到两种为期12周的干预措施之一（A组和B组）。A组将采用低热量饮食，目标是适度减重（MWL；体重减轻≤3%）。B组将采用改良的极低热量饮食（VLED）计划，目标是大幅减重（SWL；体重减轻10 - 15%）。所有参与者都将被要求遵守澳大利亚国家卫生与医学研究委员会（NHMRC）的运动指南，并将根据澳大利亚和新西兰皇家妇产科医师学院的指南提供标准的孕前建议。然后对所有参与者进行为期12个月的观察。如果在12个月的随访期内怀孕，将记录母亲的体重和代谢状况数据，以及母亲和后代的妊娠结局。主要结局是妊娠26至28周时母亲的空腹血糖，因为已知这与妊娠结局相关。受孕时间、活产率、孕期体重增加以及母亲和婴儿不良妊娠结局的综合情况将作为次要结局。
越来越强调肥胖女性在受孕前减重。迄今为止，尚无随机对照试验证明有能改善母亲和婴儿妊娠结局的有效减重方法。本研究旨在确定与标准护理相比，采用VLED实现受孕前大幅减重是否能改善母亲和婴儿的妊娠结局。这项研究可能会改变计划怀孕的肥胖女性的临床护理方式。
澳大利亚新西兰临床试验注册中心，12,614,001,160,628。于2014年11月5日注册。
