Transient Hypertension, Pregnancy
Conditions
Keywords
hypertension, blood pressure, pregnancy
Brief summary
Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to first determine whether clinicians will comply with the interventions of 'less tight' and 'tight' control of dBP, and whether the interventions will result in differences in mean dBP between groups. A pilot will also allow us to confirm the ability of centres to identify eligible women and the willingness of women to join CHIPS.
Detailed description
To determine whether 'less tight' control of mild-moderate non-proteinuric maternal hypertension, aiming for a diastolic blood pressure (dBP) of 100mmHg, can decrease the risks of adverse perinatal outcome without increasing maternal risk compared with 'tight' control, aiming for a dBP of 85mmHg.
Interventions
PROCEDURERandomized to either a 'less tight' group or a 'tight' group
Sponsors
Canadian Institutes of Health Research (CIHR)
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
* dBP 90-109mmHg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks.
Exclusion criteria
* dBP consistently \< 85mmHg by home BP monitoring; severe systolic hypertension; proteinuria; contraindication to either arm of the trial or to prolongation of pregnancy; or known lethal/major fetal anomaly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean dBP at 28, 32 and 36 weeks gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinician compliance with treatment protocols; women's satisfaction with care. | — |
Countries
Canada
Outcome results
None listed