Control of Hypertension in Pregnancy Study: A Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Mean dBP at 28, 32 and 36 weeks gestation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 48 Years (Adult)
- Sex
- Female
- Accepts 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.
Outcomes
Primary Outcomes
Mean dBP at 28, 32 and 36 weeks gestation
Secondary Outcomes
- Clinician compliance with treatment protocols; women's satisfaction with care.