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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)
Scientific title
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
Secondary ID [1] 0 0
MCT-87522
Secondary ID [2] 0 0
H08-00882
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pregnancy Loss or NICU Admission for Greater Than 48 Hours
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Serious Maternal Complications Measured up to 6 Weeks Postpartum
Timepoint [1] 0 0
6 weeks

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)
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
987
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Women's and Children's Hospital - Adelaide
Recruitment hospital [4] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [5] 0 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [6] 0 0
St John of God Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Ipswich
Recruitment postcode(s) [5] 0 0
- Subiaco
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Connecticut
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United States of America
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Kentucky
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Massachusetts
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Minnesota
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New Jersey
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North Carolina
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Oregon
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United States of America
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South Carolina
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United States of America
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Wisconsin
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Argentina
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Corrientes
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Argentina
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Mendoza
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Brazil
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Goiania
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Brazil
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Niteroi
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Rio de Janerio
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Quebec
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Regina
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Chile
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Osorno
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Chile
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Puente Alto
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Colombia
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Cali
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Estonia
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Tartu
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Hungary
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Debrecen
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Israel
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Bnei Brak
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Israel
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Hadera
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Israel
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Nazareth
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Jordan
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Amman
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Netherlands
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's-Hertogenbosch
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Almere
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Amersfoort
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Amsterdam
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Enschede
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Groningen
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Haarlem
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Zwolle
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Auckland
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Christchurch
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Gdansk
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Lodz
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Poland
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Poznan
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United Kingdom
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Basildon
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United Kingdom
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Birmingham
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Blackburn
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Bradford
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Chesterfield
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Coventry
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Derby
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Halifax
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Lancashire
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Lancaster
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Leicester
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Liverpool
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London
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Manchester
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Newcastle upon Tyne
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United Kingdom
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Nottinghamshire
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Nottingham
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United Kingdom
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Ormskirk
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United Kingdom
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Plymouth
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Sheffield
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United Kingdom
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Slough
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United Kingdom
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Sunderland
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United Kingdom
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Swansea
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United Kingdom
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Warwickshire
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United Kingdom
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Wolverhampton
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United Kingdom
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York

Funding & Sponsors
Primary sponsor type
Other
Name
University of British Columbia
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sunnybrook Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01192412
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.
Public notes

Contacts
Principal investigator
Name 0 0
Laura A Magee, MD, FRCPC, MSc, FACP
Address 0 0
The University of British Columbia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01192412