妊娠高血压控制研究试点试验

The Control of Hypertension In Pregnancy Study pilot trial.

作者信息

Magee L A, von Dadelszen P, Chan S, Gafni A, Gruslin A, Helewa M, Hewson S, Kavuma E, Lee S K, Logan A G, McKay D, Moutquin J-M, Ohlsson A, Rey E, Ross S, Singer J, Willan A R, Hannah M E

机构信息

Department of Medicine, University of British Columbia, Vancouver, Canada.

出版信息

BJOG. 2007 Jun;114(6):770, e13-20. doi: 10.1111/j.1471-0528.2007.01315.x.

DOI:10.1111/j.1471-0528.2007.01315.x

PMID:17516972

Abstract

OBJECTIVE

To determine whether 'less tight' (versus 'tight') control of nonsevere hypertension results in a difference in diastolic blood pressure (dBP) between groups.

DESIGN

Randomised controlled trial (ISRCTN#57277508).

SETTING

Seventeen obstetric centres in Canada, Australia, New Zealand, and UK.

POPULATION

Inclusion: pregnant women, dBP 90-109 mmHg, pre-existing/gestational hypertension; live fetus(es); and 20-33(+6) weeks. Exclusion: systolic blood pressure > or = 170 mmHg and proteinuria, contraindication, or major fetal anomaly.

METHODS

Randomisation to less tight (target dBP, 100 mmHg) or tight (target dBP, 85 mmHg) blood pressure control.

MAIN OUTCOME MEASURES

Primary: mean dBP at 28, 32 and 36 weeks. Secondary: clinician compliance and women's satisfaction. Other: serious perinatal and maternal complications.

RESULTS

A total of 132 women were randomised to less tight (n = 66; seven had no study visit) or tight control (n= 66; one was lost to follow up; seven had no study visit). Mean dBP was significantly lower with tight control: -3.5 mmHg, 95% credible interval (-6.4, -0.6). Clinician compliance was 79% in both groups. Women were satisfied with their care. With less tight (versus tight) control, the rates of other treatments and outcomes were the following: post-randomisation antenatal antihypertensive medication use: 46 (69.7%) versus 58 (89.2%), severe hypertension: 38 (57.6%) versus 26 (40.0%), proteinuria: 16 (24.2%) versus 20 (30.8%), serious maternal complications: 3 (4.6%) versus 2 (3.1%), preterm birth: 24 (36.4%) versus 26 (40.0%), birthweight: 2675 +/- 858 versus 2501 +/- 855 g, neonatal intensive care unit (NICU) admission: 15 (22.7%) versus 22 (34.4%), and serious perinatal complications: 9 (13.6%) versus 14 (21.5%).

CONCLUSION

The CHIPS pilot trial confirms the feasibility and importance of a large definitive trial to determine the effects of less tight control on serious perinatal and maternal complications.

摘要

目的

确定非重度高血压“较宽松”（相对于“严格”）控制是否会导致两组间舒张压（dBP）出现差异。

设计

随机对照试验（国际标准随机对照试验编号：ISRCTN#57277508）。

地点

加拿大、澳大利亚、新西兰和英国的17个产科中心。

研究对象

纳入标准：孕妇，舒张压90 - 109 mmHg，孕前/妊娠期高血压；存活胎儿；孕周20 - 33（+6）周。排除标准：收缩压≥170 mmHg且有蛋白尿、禁忌证或严重胎儿畸形。

方法

随机分为较宽松（目标舒张压100 mmHg）或严格（目标舒张压85 mmHg）血压控制组。

主要观察指标

主要指标：孕28、32和36周时的平均舒张压。次要指标：临床医生依从性和女性满意度。其他指标：严重围产期和母体并发症。

结果

共有132名女性被随机分组，较宽松控制组（n = 66；7人未进行研究访视）和严格控制组（n = 66；1人失访；7人未进行研究访视）。严格控制组的平均舒张压显著更低：-3.5 mmHg，95%可信区间（-6.4，-0.6）。两组临床医生的依从性均为79%。女性对其治疗护理感到满意。较宽松（相对于严格）控制组的其他治疗及结局发生率如下：随机分组后产前使用抗高血压药物：46（69.7%）对58（89.2%），重度高血压：38（57.6%）对(26)（40.0%），蛋白尿：16（24.2%）对20（30.8%），严重母体并发症：3（4.6%）对2（3.1%），早产：24（36.4%）对26（40.0%），出生体重：2675±858对2501±855 g，新生儿重症监护病房（NICU）入院率：15（22.7%）对22（34.4%），严重围产期并发症：9（13.6%）对14（21.5%）。