CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial

Sunnybrook Health Sciences Centre132 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Transient Hypertension, Pregnancy

Interventions

Randomized to either a 'less tight' group or a 'tight' groupPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

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.

Locations (1)

Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Mean dBP at 28, 32 and 36 weeks gestation

Secondary Outcomes

Clinician compliance with treatment protocols; women's satisfaction with care.

Data from ClinicalTrials.gov

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