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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transient Hypertension, Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No