Condition category
Pregnancy and Childbirth
Date applied
05/11/2003
Date assigned
28/11/2003
Last edited
19/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.utoronto.ca/miru/chips/res_summ.htm

Contact information

Type

Scientific

Primary contact

Dr Laura Magee

ORCID ID

Contact details

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

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 measures

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. Women’s 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

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

http://www.utoronto.ca/

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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/pubmed/17516972

Publication citations

  1. 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.

Additional files

Editorial Notes