• BJOG · Jun 2007

    Randomized Controlled Trial Multicenter Study

    The Control of Hypertension In Pregnancy Study pilot trial.

    • L A Magee, P von Dadelszen, S Chan, A Gafni, A Gruslin, M Helewa, S Hewson, E Kavuma, S K Lee, A G Logan, D McKay, J-M Moutquin, A Ohlsson, E Rey, S Ross, J Singer, A R Willan, M E Hannah, and CHIPS Pilot Trial Collaborative Group.
    • Department of Medicine, University of British Columbia, Vancouver, Canada. LMagee@cw.bc.ca
    • BJOG. 2007 Jun 1;114(6):770, e13-20.

    ObjectiveTo determine whether 'less tight' (versus 'tight') control of nonsevere hypertension results in a difference in diastolic blood pressure (dBP) between groups.DesignRandomised controlled trial (ISRCTN#57277508).SettingSeventeen obstetric centres in Canada, Australia, New Zealand, and UK.PopulationInclusion: 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.MethodsRandomisation to less tight (target dBP, 100 mmHg) or tight (target dBP, 85 mmHg) blood pressure control.Main Outcome MeasuresPrimary: mean dBP at 28, 32 and 36 weeks. Secondary: clinician compliance and women's satisfaction. Other: serious perinatal and maternal complications.ResultsA 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%).ConclusionThe 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.

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