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
Contact information
Dr Laura Magee
Scientific
Scientific
790 Bay Street., 7th Floor
Toronto
M5G 1N8
Canada
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CHIPS |
| Study objectives | 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(s) | Trial has been approved by the University of British Columbia Research Ethics Board. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2003 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 132 women (66/group) |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
790 Bay Street., 7th Floor
Toronto
M5G 1N8
Canada
M5G 1N8
Canada
Sponsor information
University of Toronto Maternal, Infant and Reproductive Health Research Unit (Canada)
University/education
University/education
790 Bay Street., 7th Floor
Toronto
M5G 1N8
Canada
| Website | http://www.utoronto.ca/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
