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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01192412
Registration number
NCT01192412
Ethics application status
Date submitted
30/08/2010
Date registered
1/09/2010
Date last updated
11/01/2017
Titles & IDs
Public title
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
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Scientific title
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
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Secondary ID [1]
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MCT-87522
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Secondary ID [2]
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H08-00882
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gestational Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Intervention is blood pressure management approach
Treatment: Surgery - Intervention is blood pressure management approach.
Active comparator: 'Less tight' control. - The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Active comparator: 'Tight' control. - The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Treatment: Surgery: Intervention is blood pressure management approach
1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is \>105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP \<100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery.
Treatment: Surgery: Intervention is blood pressure management approach.
'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is \<80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is \>85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pregnancy Loss or NICU Admission for Greater Than 48 Hours
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Assessment method [1]
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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.
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Timepoint [1]
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6 weeks
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Secondary outcome [1]
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Serious Maternal Complications Measured up to 6 Weeks Postpartum
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Assessment method [1]
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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)
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Timepoint [1]
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6 weeks
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Eligibility
Key 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)
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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 greater than or equal to 14+0 weeks' gestation
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2014
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Sample size
Target
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Accrual to date
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Final
987
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Recruitment in Australia
Recruitment state(s)
NSW
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Campbelltown Hospital - Campbelltown
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Liverpool Hospital - Liverpool
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Women's and Children's Hospital - Adelaide
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Ipswich Hospital - Ipswich
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King Edward Memorial Hospital - Subiaco
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St John of God Hospital - Subiaco
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- Campbelltown
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- Liverpool
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- Adelaide
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- Ipswich
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Recruitment postcode(s) [5]
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- Subiaco
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Recruitment outside Australia
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United States of America
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Connecticut
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of British Columbia
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Address
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Government body
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Canadian Institutes of Health Research (CIHR)
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Other
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Sunnybrook Research Institute
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Ethics approval
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Summary
Brief summary
The investigators do not know which approach to treatment of non-severe high blood pressure in pregnancy is better for women and babies. In the CHIPS Trial, the investigators seek to determine whether 'less tight' control (aiming for a diastolic blood pressure \[dBP\] of 100 mmHg), compared with 'tight' control (aiming for a diastolic blood pressure \[dBP\] of 85 mmHg) can decrease the risks of adverse baby outcomes without increasing the risk of problems for the mother.
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Trial website
https://clinicaltrials.gov/study/NCT01192412
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Trial related presentations / publications
Magee LA, Singer J, Lee T, McManus RJ, Lay-Flurrie S, Rey E, Chappell LC, Myers J, Logan AG, von Dadelszen P. Are blood pressure level and variability related to pregnancy outcome? Analysis of control of hypertension in pregnancy study data. Pregnancy Hypertens. 2020 Jan;19:87-93. doi: 10.1016/j.preghy.2019.12.002. Epub 2020 Jan 9. Vidler M, Magee LA, von Dadelszen P, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez J, Singer J, Gafni A, Gruslin A, Helewa M, Hutton E, Lee SK, Lee T, Logan AG, Ganzevoort W, Welch R, Thornton JG, Moutquin JM; CHIPS Study Group. Women's views and postpartum follow-up in the CHIPS Trial (Control of Hypertension in Pregnancy Study). Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:105-113. doi: 10.1016/j.ejogrb.2016.07.509. Epub 2016 Sep 10. Magee LA, von Dadelszen P, Singer J, Lee T, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez J, Gafni A, Helewa M, Hutton E, Koren G, Lee SK, Logan AG, Ganzevoort W, Welch R, Thornton JG, Moutquin JM; CHIPS Study Group*. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study): Is Severe Hypertension Just an Elevated Blood Pressure? Hypertension. 2016 Nov;68(5):1153-1159. doi: 10.1161/HYPERTENSIONAHA.116.07862. Epub 2016 Sep 12. Ahmed RJ, Gafni A, Hutton EK, Hu ZJ, Pullenayegum E, von Dadelszen P, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez JJ, Ganzevoort W, Helewa M, Lee SK, Lee T, Logan AG, Moutquin JM, Singer J, Thornton JG, Welch R, Magee LA. The Cost Implications of Less Tight Versus Tight Control of Hypertension in Pregnancy (CHIPS Trial). Hypertension. 2016 Oct;68(4):1049-55. doi: 10.1161/HYPERTENSIONAHA.116.07466. Epub 2016 Aug 22. Magee LA, von Dadelszen P, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez J, Singer J, Gafni A, Gruslin A, Helewa M, Hutton E, Lee SK, Lee T, Logan AG, Ganzevoort W, Welch R, Thornton JG, Moutquin JM. Less-tight versus tight control of hypertension in pregnancy. N Engl J Med. 2015 Jan 29;372(5):407-17. doi: 10.1056/NEJMoa1404595.
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Public notes
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Contacts
Principal investigator
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Laura A Magee, MD, FRCPC, MSc, FACP
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Address
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The University of British Columbia
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01192412
Download to PDF