Non-proteinuric pre-existing or gestational hypertension in pregnancy Pregnancy and Childbirth Gestational [pregnancy-induced] hypertension with significant proteinuria
Conditions
Interventions
Experimental group:
'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is greater than or equal to 105 mmHg, then antihypertensive medication must be started or increased in
Sponsors
University of British Columbia (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy loss or NICU admission for greater than 48 hours, as recorded in the maternal and infant medical records immediately following the birth (or pregnancy loss), and then again after the mothers' and infants' discharge home. Supplemental information, about potential post-discharge maternal or neonatal morbidities in the 6 weeks following birth for the mother, or 28 days of life for the baby, will be obtained by contacting women at 6 weeks postpartum and/or from medical records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious maternal complications measured up to 6 weeks postpartum. Death or one or more life-threatening maternal complications: 1. Adverse neurological complications (stroke, eclampsia, and/or blindness), and/or 2. End-organ failure (uncontrolled hypertension, inotropic support, pulmonary oedema, respiratory failure, myocardial ischaemia/infarction, renal failure, coagulopathy, and/or transfusion) | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Estonia, Hungary, Israel, Jordan, Netherlands, New Zealand, Poland, United Kingdom, United States of America
Outcome results
None listed