The CHIPS trial: Control of Hypertension In Pregnancy Study

niversity of British Columbia (Canada)0 个研究点目标入组 1,028 人开始时间: 2008年7月31日最近更新: 2018年5月28日

试验速览

•1. Pre-existing or gestational hypertension (pre-existing hypertension is dBP greater than or equal to 90 mmHg before pregnancy or 20 weeks' gestation; gestational hypertension is dBP greater than or equal to 90 mmHg that develops after 20 weeks)
•2. dBP of 90 - 105 mmHg if NOT TAKING antihypertensive therapy, or dBP of 85 - 105 mmHg if TAKING antihypertensive therapy
•3. Live foetus (confirmed by Doptone assessment of foetal heart tones within one week before randomisation)
•4. Gestational age 14 - 33+6 weeks (as measured by last menstrual period or dating ultrasound)

•Amendments as of 15/03/2010:
•Please note that as of the above date, this record has been updated to include a protocol amendment (approved 17/03/2009) to point 3 of the exclusion criteria below. This should now read as follows:
•3. Use of an angiotensin converting enzyme (ACE) inhibitor at greater than or equal to 14+0 weeks' gestation
•Initial exclusion criteria at time of registration:
•1. Severe systolic hypertension (defined as a systolic blood pressure [sBP] greater than or equal to 160 mmHg at randomisation)
•2. Proteinuria (defined as greater than or equal to 0.3 g/d by 24 hour urine collection, or if a 24 hour urine collection is not available, by a urinary protein:creatinine ratio of greater than or equal to 30 mg/mmol or urinary dipstick of greater than or equal to 2+)
•3. Use of an angiotensin converting enzyme (ACE) inhibitor at any time in the pregnancy
•4. Contraindication to either arm of the trial or to pregnancy prolongation
•5. Known multiple gestation
•6. Known lethal or major foetal anomaly
•7. Plan to terminate pregnancy
•8. Prior participation in CHIPS

发起方

niversity of British Columbia (Canada)