CHIPS (Control of Hypertension in Pregnancy Study): a pilot trial

ISRCTN ISRCTN57277508
DOI https://doi.org/10.1186/ISRCTN57277508
ClinicalTrials.gov number NCT00187395
Secondary identifying numbers N/A
Submission date
05/11/2003
Registration date
28/11/2003
Last edited
19/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Laura Magee
Scientific

790 Bay Street., 7th Floor
Toronto
M5G 1N8
Canada

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymCHIPS
Study objectivesTo 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(s)Trial has been approved by the University of British Columbia Research Ethics Board.
Health condition(s) or problem(s) studiedMild-Moderate hypertension particularly of the short-term period of pregnancy.
InterventionWomen 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 typeOther
Primary outcome measure1. Mean dBP at 28, 32 and 36 weeks gestation
2. One/more serious perinatal complications or birth weight less than third centile
Secondary outcome measures1. Clinician compliance with treatment protocols
2. Women’s satisfaction with care
3. One/more serious maternal complications

Other outcomes:
1. Very severe hypertension
2. Pre-eclampsia
Overall study start date01/03/2003
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants132 women (66/group)
Key inclusion criteriaWomen 18 - 50 years old with mild to moderate non-proteinuric pre-existing or gestational hypertension that presents at 20-33+6 weeks gestation.
Key exclusion criteria1. 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
Date of first enrolment01/03/2003
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Canada

Study participating centre

790 Bay Street., 7th Floor
Toronto
M5G 1N8
Canada

Sponsor information

University of Toronto Maternal, Infant and Reproductive Health Research Unit (Canada)
University/education

790 Bay Street., 7th Floor
Toronto
M5G 1N8
Canada

Website http://www.utoronto.ca/
ROR logo "ROR" https://ror.org/03dbr7087

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59755)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 01/06/2007 Yes No