Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00187395
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CHIPS
Study hypothesis
To determine whether less tight control of mild-moderate nonproteinuric maternal hypertension, aiming for a diastolic Blood Pressure (dBP) of 100 mmHg, can decrease the risks of adverse perinatal outcome without increasing maternal risk compared with tight control, aiming for a dBP of 85 mmHg.
This is the pilot study for the main randomised trial registered under ISRCTN71416914.
Ethics approval
Trial has been approved by the University of British Columbia Research Ethics Board.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mild-Moderate hypertension particularly of the short-term period of pregnancy.
Intervention
Women will be randomised to either a 'less tight' group aiming for a dialstolic Blood Pressure (dBP) of 100 mmHg of maternal hypertension or a 'tight' group aiming for a diastolic BP of 85 mmHg of maternal hypertension.
'Less tight' control: a target dBP of 100 mmHg
1. If dBP is 95 - 99 mmHg, consideration should be given to decreasing the dose or stopping antihypertensive therapy among women already on treatment, and therapy should not be started among women on no treatment.
2. If dBP is less than 95 mmHg, antihypertensive therapy should definitely be decreased
in dose or stopped among women already on treatment, and should not be started among women on no treatment.
3. If dBP is 101 - 105 mmHg, consideration should be given to starting antihypertensive therapy or increasing the dose of existing medication.
4. If dBP is greater than 105 mmHg, antihypertensive therapy should definitely be started or existing medication increased in dose.
'Tight' control: a target dBP of 85 mmHg
1. If dBP is 80 - 84 mmHg, consideration should be given to stopping or decreasing the dose of antihypertensive therapy among women already on treatment, and therapy should not be started among women already on treatment.
2. If dBP is less than 80 mmHg, antihypertensive therapy should definitely be decreased in dose or stopped among women already on treatment, and should not be started among women on no treatment.
3. If dBP is 86 - 90 mmHg, consideration should be given to starting or increasing the dose of existing antihypertensive medication.
4. If dBP is greater than 90 mmHg, antihypertensive therapy should definitely be started or existing medication increased in dose.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Mean dBP at 28, 32 and 36 weeks gestation
2. One/more serious perinatal complications or birth weight less than third centile
Secondary outcome measures
1. Clinician compliance with treatment protocols
2. Womens satisfaction with care
3. One/more serious maternal complications
Other outcomes:
1. Very severe hypertension
2. Pre-eclampsia
Overall trial start date
01/03/2003
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women 18 - 50 years old with mild to moderate non-proteinuric pre-existing or gestational hypertension that presents at 20-33+6 weeks gestation.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
132 women (66/group)
Participant exclusion criteria
1. dBP consistently less than 85 mmHg by home BP monitoring
2. Severe systolic hypertension
3. Proteinuria
4. Contraindication to either arm of the trial or to prolongation of pregnancy
5. Known lethal/major fetal anomaly
Recruitment start date
01/03/2003
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Canada
Trial participating centre
790 Bay Street., 7th Floor
Toronto
M5G 1N8
Canada
Sponsor information
Organisation
University of Toronto Maternal, Infant and Reproductive Health Research Unit (Canada)
Sponsor details
790 Bay Street.
7th Floor
Toronto
M5G 1N8
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59755)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results: http://www.ncbi.nlm.nih.gov/pubmed/17516972
Publication citations
-
Results
Magee LA, von Dadelszen P, Chan S, Gafni A, Gruslin A, Helewa M, Hewson S, Kavuma E, Lee SK, Logan AG, McKay D, Moutquin JM, Ohlsson A, Rey E, Ross S, Singer J, Willan AR, Hannah ME, , The Control of Hypertension In Pregnancy Study pilot trial., BJOG, 2007, 114, 6, 770, e13-20, doi: 10.1111/j.1471-0528.2007.01315.x.