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| [ ...Back to search results ] | [ Print-friendly version ] |
| The CHIPS trial: Control of Hypertension In Pregnancy Study |
| ISRCTN | ISRCTN71416914 |
| ClinicalTrials.gov identifier | |
| Public title | The CHIPS trial: Control of Hypertension In Pregnancy Study |
| Scientific title | |
| Acronym | CHIPS |
| Serial number at source | MCT-87522 |
| Study hypothesis |
As of 15/03/2010 this record has been updated to include a protocol amendment to the exclusion criteria, and the addition of the following countries to the countries of recruitment field: Colombia, Equatorial Guinea, Estonia, Poland, Qatar.
Primary research question: For pregnant women with non-severe, non-proteinuric maternal hypertension at 14 - 33 weeks, will 'less tight' control (target diastolic blood pressure [dBP] of 100 mmHg) versus 'tight' control (target dBP of 85 mmHg) increase (or decrease) the likelihood of pregnancy loss or Neonatal Intensive Care Unit (NICU) admission for greater than 48 hours? Secondary research question: Will 'less tight' versus 'tight' control increase (or decrease) the likelihood of serious maternal complications? Other research questions: Will 'less tight' versus 'tight' control: 1. Increase (or decrease) the likelihood of serious perinatal complications? 2. Increase (or decrease) the likelihood of severe hypertension and pre-eclampsia? 3. Increase (or decrease) the likelihood of maternal satisfaction with care? 4. Result in significant changes in dBP or health care costs? This is the resulting randomised trial from the pilot study registered under ISRCTN57277508. |
| Lay summary | |
| Ethics approval | Ethics approval received from the University of British Columbia Clinical Research Ethics Board (UBC CREB) on the 14th July 2008. |
| Study design | Unblinded, randomised parallel assignment trial |
| Countries of recruitment | Argentina, Australia, Brazil, Canada, Chile, Colombia, Equatorial Guinea, Estonia, France, Israel, Jordan, Malaysia, Netherlands, New Zealand, Poland, Qatar, South Africa, United Kingdom, United States of America |
| Disease/condition/study domain | Non-proteinuric pre-existing or gestational hypertension in pregnancy |
| Participants - inclusion criteria |
1. Pre-existing or gestational hypertension (pre-existing hypertension is dBP greater than or equal to 90 mmHg before pregnancy or 20 weeks' gestation; gestational hypertension is dBP greater than or equal to 90 mmHg that develops after 20 weeks)
2. dBP of 90 - 105 mmHg if NOT TAKING antihypertensive therapy, or dBP of 85 - 105 mmHg if TAKING antihypertensive therapy 3. Live foetus (confirmed by Doptone assessment of foetal heart tones within one week before randomisation) 4. Gestational age 14 - 33+6 weeks (as measured by last menstrual period or dating ultrasound) |
| Participants - exclusion criteria |
Amendments as of 15/03/2010:
Please note that as of the above date, this record has been updated to include a protocol amendment (approved 17/03/2009) to point 3 of the exclusion criteria below. This should now read as follows: 3. Use of an angiotensin converting enzyme (ACE) inhibitor at greater than or equal to 14+0 weeks' gestation Initial exclusion criteria at time of registration: 1. Severe systolic hypertension (defined as a systolic blood pressure [sBP] greater than or equal to 160 mmHg at randomisation) 2. Proteinuria (defined as greater than or equal to 0.3 g/d by 24 hour urine collection, or if a 24 hour urine collection is not available, by a urinary protein:creatinine ratio of greater than or equal to 30 mg/mmol or urinary dipstick of greater than or equal to 2+) 3. Use of an angiotensin converting enzyme (ACE) inhibitor at any time in the pregnancy 4. Contraindication to either arm of the trial or to pregnancy prolongation 5. Known multiple gestation 6. Known lethal or major foetal anomaly 7. Plan to terminate pregnancy 8. Prior participation in CHIPS |
| Anticipated start date | 01/04/2009 |
| Anticipated end date | 31/10/2013 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at: http://www.utoronto.ca/cmicr/chips/ |
| Target number of participants | 1028 |
| Interventions |
Experimental group:
'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is greater than or equal to 105 mmHg, then antihypertensive medication must be started or increased in dose. The intervention will be applied until delivery. Control group: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is less than or equal to 80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. The intervention will be applied until delivery. |
| Primary outcome measure(s) | Pregnancy loss or NICU admission for greater than 48 hours, as recorded in the maternal and infant medical records immediately following the birth (or pregnancy loss), and then again after the mothers' and infants' discharge home. Supplemental information, about potential post-discharge maternal or neonatal morbidities in the 6 weeks following birth for the mother, or 28 days of life for the baby, will be obtained by contacting women at 6 weeks postpartum and/or from medical records. |
| Secondary outcome measure(s) |
Serious maternal complications measured up to 6 weeks postpartum. Death or one or more life-threatening maternal complications:
1. Adverse neurological complications (stroke, eclampsia, and/or blindness), and/or 2. End-organ failure (uncontrolled hypertension, inotropic support, pulmonary oedema, respiratory failure, myocardial ischaemia/infarction, renal failure, coagulopathy, and/or transfusion) |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87522) |
| Trial website | http://www.utoronto.ca/cmicr/chips/ |
| Publications | |
| Contact name | Dr Laura Ann Magee |
| Address |
BC Women's Hospital and Health Centre
4500 Oak Street, Room D213 |
| City/town | Vancouver |
| Zip/Postcode | V6H 3N1 |
| Country | Canada |
| Tel | +1 604 875 2424 ext. 6012 |
| Fax | +1 604 875 2961 |
| chips@cw.bc.ca | |
| Sponsor | University of British Columbia (Canada) |
| Address |
c/o Dean Kuusela
102-6190 Agronomy Road |
| City/town | Vancouver |
| Zip/Postcode | V6T 1Z4 |
| Country | Canada |
| Sponsor website: | http://www.ubc.ca/ |
| Date applied | 31/07/2008 |
| Last edited | 15/03/2010 |
| Date ISRCTN assigned | 31/07/2008 |
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