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产后高血压的自我管理:SNAP-HT 试验。

Self-Management of Postnatal Hypertension: The SNAP-HT Trial.

机构信息

From the Nuffield Department of Primary Care Health Sciences (A.E.C., K.L.T., S.M., J.M., R.J.M.)

From the Nuffield Department of Primary Care Health Sciences (A.E.C., K.L.T., S.M., J.M., R.J.M.).

出版信息

Hypertension. 2018 Aug;72(2):425-432. doi: 10.1161/HYPERTENSIONAHA.118.10911. Epub 2018 Jul 2.

Abstract

UNLABELLED

Hypertension affects 1 in 10 pregnancies, often persisting postpartum, when antihypertensive requirements may vary substantially. This unmasked, randomized controlled trial evaluated the feasibility and effects on blood pressure (BP) of self-management of postpartum hypertension. Women with gestational hypertension or preeclampsia, requiring postnatal antihypertensive treatment, were randomized to self-management or usual care. Self-management entailed daily home BP monitoring and automated medication reduction via telemonitoring. Women attended 5 follow-up visits during 6 months. The primary outcome was feasibility: specifically recruitment, retention, and compliance with follow-up rates. Secondary outcomes included BP control and safety, analyzed on an intention-to-treat basis. Forty-nine percent (91/186) of those women approached were randomized (45 intervention, 46 control), and 90% (82/91) finished follow-up. The groups had similar baseline characteristics. After randomization, BP was lower in the intervention group, most markedly at 6 weeks: intervention group mean (SD), systolic 121.6 (8.7)/diastolic 80.5 (6.6) mm Hg; control group, systolic 126.6 (11.0)/diastolic 86.0 (9.7) mm Hg; adjusted differences (95% confidence interval), systolic -5.2 (-9.3 to -1.2)/diastolic -5.8 (-9.1 to -2.5) mm Hg. Diastolic BP remained significantly lower in those self-managing to 6 months: adjusted difference -4.5 (-8.1 to -0.8) mm Hg. This is the first randomized evaluation of BP self-management postpartum and indicates it would be feasible to trial this intervention in larger studies. Self-management resulted in better diastolic BP control to 6 months, even beyond medication cessation.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT02333240.

摘要

未标注

高血压影响十分之一的妊娠,通常在产后持续存在,此时降压需求可能会有很大变化。这项未设盲、随机对照试验评估了产后高血压自我管理的可行性及其对血压(BP)的影响。患有妊娠高血压或先兆子痫、需要产后降压治疗的女性被随机分为自我管理或常规护理组。自我管理包括每天在家中监测血压和通过远程监测自动减少药物剂量。女性在 6 个月内接受 5 次随访。主要结局是可行性:具体来说是招募、保留和随访率的依从性。次要结局包括血压控制和安全性,均基于意向治疗进行分析。91/186 名符合条件的女性被随机分组(45 名干预组,46 名对照组),其中 90%(82/91)完成了随访。两组的基线特征相似。随机分组后,干预组的血压较低,在 6 周时最为明显:干预组平均(标准差)收缩压为 121.6(8.7)/舒张压为 80.5(6.6)mmHg;对照组为 126.6(11.0)/舒张压 86.0(9.7)mmHg;调整后的差异(95%置信区间)为收缩压-5.2(-9.3 至-1.2)/舒张压-5.8(-9.1 至-2.5)mmHg。到 6 个月时,自我管理组的舒张压仍显著较低,调整后的差异为-4.5(-8.1 至-0.8)mmHg。这是首次对产后血压自我管理进行随机评估,表明在更大规模的研究中对该干预措施进行试验是可行的。自我管理可实现到 6 个月时更好的舒张压控制,甚至在停药后也是如此。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT02333240。

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