The Control of Hypertension In Pregnancy Study pilot trial.
The Control of Hypertension In Pregnancy Study pilot trial.
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DOI：
10.1111/j.1471-0528.2007.01315.x
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发表时间：
2007-06-01
期刊：
影响因子：
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通讯作者：
Hannah, M E
中科院分区：
文献类型：
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作者：
Magee, L A;von Dadelszen, P;Hannah, M E
目的：以确定是否“不太紧”对非重度高血压的严格控制导致两组间舒张压的差异。设计：随机对照试验地点：加拿大、澳大利亚、新西兰和英国的17个产科中心。人群：纳入：孕妇，舒张压90-109 mmHg，既往/妊娠期高血压;活胎; 20-33（+6）周。排除：收缩压≥ 170 mmHg和蛋白尿、禁忌症或重大胎儿畸形。方法：随机分为不太严格（目标DBP，100 mmHg）或严格（目标DBP，85 mmHg）血压控制组。主要观察指标：28，32和36周时的平均DBP。次要因素：临床医生依从性和女性满意度。其他：结果：共有132名妇女被随机分为不太严格（n = 66; 7人没有研究访问）或严格控制（n= 66; 1人失访; 7人没有研究访问）。严格控制的平均DBP显著降低：-3.5 mmHg，95%可信区间（-6.4，-0.6）。两组的临床医生依从性均为79%。妇女对他们的照顾感到满意。不那么紧（与严格）控制相比，其他治疗的发生率和结局如下：随机化后产前抗高血压药物用途：46（69.7%）与58（89.2%），重度高血压38例（57.6%）与26（40.0%），蛋白尿：16（24.2%）与20（30.8%），严重孕产妇并发症：3例（4.6%）对比2早产：24人（36.4%）对比26（40.0%），出生体重：2675 +/- 858 vs 2501 +/- 855 g，新生儿重症监护室（NICU）入院：15（22.7%）对22（34.4%），严重围产期并发症：9（13.6%）对14（21.5%）。结论：CHIPS先导试验证实了一项大型确定性试验的可行性和重要性，以确定不太严格的控制对严重围产期和母体并发症的影响。
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.