School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia.
The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.
Pregnancy Hypertens. 2020 Oct;22:1-6. doi: 10.1016/j.preghy.2020.07.001. Epub 2020 Jul 9.
Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
BP will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.
患有妊娠高血压疾病（HDP）的女性在以后的生活中发生母体心血管疾病的风险增加一倍。本研究（BP）的主要目的是比较 3 种不同管理策略的结果，包括产后 12 个月内的生活方式改变（LBC），在先前妊娠中患有 HDP 的女性中。次要目的包括评估对其他心血管代谢参数的影响。
在澳大利亚大都市医院进行的三臂多中心随机试验（注册：ACTRN12618002004246），目标样本量为 480 名参与者。将参与者随机分为三组：1）优化的常规护理：产后 6 个月提供信息包和家庭医生随访；2）简短干预：按照组 1 提供信息包，以及在妇产科医生和营养师的专门诊所进行评估和简短的 LBC 咨询，产后 6 个月；3）扩展干预：按照组 2 进行，同时在产后 6 至 12 个月期间参加基于电话的 6 个月 LBC 计划。所有女性在 12 个月时进行结局评估。
主要结局：（a）血压变化或（b）体重变化和/或腰围变化。
产妇健康相关生活质量、LBC 计划的参与和保留率、生化标志物、血管功能测试、婴儿体重轨迹、增量成本效益比。该研究具有检测组间收缩压差异 4mmHg 或体重减轻 4kg/腰围变化 2cm 的能力。
BP 将提供有关产后 LBC 干预和结构化临床随访在改善 HDP 后心血管健康标志物方面的可行性和有效性的证据。
