The CHIPS Trial (Control of Hypertension In Pregnancy Study)
3 other identifiers
interventional
987
15 countries
111
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
January 11, 2017
CompletedJanuary 11, 2017
November 1, 2016
4.8 years
August 30, 2010
August 30, 2016
November 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy Loss or NICU Admission for Greater Than 48 Hours
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.
6 weeks
Secondary Outcomes (1)
Serious Maternal Complications Measured up to 6 Weeks Postpartum
6 weeks
Study Arms (2)
'Less tight' control.
ACTIVE COMPARATORThe diastolic blood pressure (dBP) treatment goal is 100 mmHg.
'Tight' control.
ACTIVE COMPARATORThe diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Interventions
'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.
Eligibility Criteria
You may qualify if:
- 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)
- dBP of 90 - 105 mmHg if NOT TAKING antihypertensive therapy, or dBP of 85 - 105 mmHg if TAKING antihypertensive therapy
- Live foetus (confirmed by Doptone assessment of foetal heart tones within one week before randomisation)
- Gestational age 14 - 33+6 weeks (as measured by last menstrual period or dating ultrasound)
You may not qualify if:
- Severe systolic hypertension (defined as a systolic blood pressure \[sBP\] greater than or equal to 160 mmHg at randomisation)
- 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+)
- Use of an angiotensin converting enzyme (ACE) inhibitor at greater than or equal to 14+0 weeks' gestation
- Contraindication to either arm of the trial or to pregnancy prolongation
- Known multiple gestation
- Known lethal or major foetal anomaly
- Plan to terminate pregnancy
- Prior participation in CHIPS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Canadian Institutes of Health Research (CIHR)collaborator
- Sunnybrook Research Institutecollaborator
Study Sites (111)
Yale-New Haven Hospital
New Haven, Connecticut, United States
Norton Hospital Downtown
Louisville, Kentucky, United States
Norton Suburban Hospital
Louisville, Kentucky, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cooper University Hospital
Camden, New Jersey, United States
University of North Carolina
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Meriter Hospital
Madison, Wisconsin, United States
Hospital JR Vidal
Corrientes, Argentina
Hospital LC Lagomaggiore
Mendoza, Argentina
Hospital Avellaneda
San Miguel de TucumĂ¡n, Argentina
Hospital JM Cullen
Santa Fe, Argentina
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Women's and Children's Hospital
Adelaide, Australia
Ipswich Hospital
Ipswich, Australia
King Edward Memorial Hospital
Subiaco, Australia
St John of God Hospital
Subiaco, Australia
Hospital Materno Infantil
GoiĂ¢nia, Brazil
Hospital Universitario Antonio Pedro
NiterĂ³i, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Brazil
Maternidade Escola da UFRJ
Rio de Janeiro, Brazil
Clinica Perinatal Barra
Rio de Janerio, Brazil
Laranjeiras Clinica Perinatal
Rio de Janerio, Brazil
Maternidade Escola de Vila Nova Cachoeirinha
SĂ£o Paulo, Brazil
Calgary Health Region - Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia, Canada
University of British Columbia, Department of Obstetrics & Gynaecology
Vancouver, British Columbia, V6H 3N1, Canada
Children's & Women's Health Centre of BC
Vancouver, British Columbia, Canada
St Paul's Hospital
Vancouver, British Columbia, Canada
St Boniface General Hospital
Winnipeg, Manitoba, Canada
Women's Health Centre
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Civic Division
Ottawa, Ontario, Canada
Ottawa Hospital General Division
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Hopital Sainte-Justine
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
CHUS Fleurimont
Sherbrooke, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Regina General Hospital
Regina, Canada
Hospital Base Osorno
Osorno, Chile
Hospital Dr Sotero del Rio
Puente Alto, Chile
Clinica Materno Infantil Farallones
Cali, Colombia
Clinica Versalles
Cali, Colombia
Corporacion Conmfenalco Valle - Universidad Libre
Cali, Colombia
Tartu University Hospital-Women's Clinic
Tartu, Estonia
University of Debrecen
Debrecen, Hungary
Ma'ayney Hayeshua Medical Center
Bnei Brak, Israel
Hillel Yaffe Medical Center
Hadera, Israel
Nazareth Hospital (EMMS)
Nazareth, Israel
Islamic Hospital
Amman, Jordan
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Flevo ziekenhuis
Almere Stad, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Academic Medical Center
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
VU Medical Center
Amsterdam, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
UMCG
Groningen, Netherlands
Kennemer Gasthuis Haarlem
Haarlem, Netherlands
Tergooiziekenhuizen
Hilversum, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
MUMC Maastricht
Maastricht, Netherlands
St Antonius Ziekenhuis
Nieuwegein, Netherlands
Ziekenhuis Bernhoven
Oss, Netherlands
Diakonessen Ziekenhuis
Utrecht, Netherlands
UMCU
Utrecht, Netherlands
Maxima Medical Centre
Veldhoven, Netherlands
Isala Klinieken Zwolle
Zwolle, Netherlands
Waitemata Health-North Shore Hospital
Auckland, New Zealand
Christchurch Women's Hospital
Christchurch, New Zealand
Medical University of Gdansk
Gdansk, Poland
Polish Mothers Memorial Hospital
Lodz, Poland
University School of Medical Sciences
Poznan, Poland
Basildon & Thurrock University Hospital
Basildon, United Kingdom
Birmingham Women's Hospital
Birmingham, United Kingdom
East Lancashire Hospitals NHS Trust
Blackburn, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Chesterfield Royal Hospital
Chesterfield, United Kingdom
University Hospital Coventry and Warwickshire
Coventry, United Kingdom
The Royal Derby Hospital
Derby, United Kingdom
Calderdale Royal Hospital
Halifax, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Lancashire, United Kingdom
Royal Lancaster Infirmary
Lancaster, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Liverpool Women's Hospital
Liverpool, United Kingdom
Guy's & St Thomas' Hospital
London, United Kingdom
Queen Elizabeth Hospital
London, United Kingdom
St Mary's Hospital
Manchester, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Queen's Medical Centre
Nottingham, United Kingdom
King's Mill Hospital
Nottinghamshire, United Kingdom
Southport & Ormskirk Hospital
Ormskirk, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Wexham Park Hospital
Slough, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Singleton Hospital
Swansea, United Kingdom
South Warwickshire NHS Trust
Warwickshire, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
York District Hospital
York, United Kingdom
Related Publications (6)
Metcalfe RK, Harrison M, Singer J, Lewisch M, Lee T, von Dadelszen P, Magee LA, Bansback N; CHIPS Study Group. Using a patient-centred composite endpoint in a secondary analysis of the Control of Hypertension in Pregnancy Study (CHIPS) Trial. Trials. 2023 Feb 7;24(1):99. doi: 10.1186/s13063-023-07118-1.
PMID: 36750953DERIVEDMagee 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.
PMID: 31927325DERIVEDVidler 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.
PMID: 27665372DERIVEDMagee 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.
PMID: 27620393DERIVEDAhmed 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.
PMID: 27550914DERIVEDMagee 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.
PMID: 25629739DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Women with preexisting or gestational hypertension included, and may have differing management. Primary/secondary outcomes included causes of pregnancy loss and interventions for neonatal care not expected to be associated with maternal BP control
Results Point of Contact
- Title
- Dr. Laura A. Magee
- Organization
- St. George's, University of London
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Magee, MD, FRCPC, MSc, FACP
The University of British Columbia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 1, 2010
Study Start
April 1, 2009
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
January 11, 2017
Results First Posted
January 11, 2017
Record last verified: 2016-11