The CHIPS Trial (Control of Hypertension In Pregnancy Study)

November 15, 2016 updated by: University of British Columbia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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?

Treatment Allocation:

Eligible women will be randomised centrally to either 'less tight' control (aiming for dBP of 100mmHg) or 'tight' control (aiming for dBP of 85mmHg) of their hypertension.

Randomisation will be stratified by centre and type of hypertension (pre-existing or gestational).

  • In the 'less tight' control group, if dBP is ≥105mmHg, then antihypertensive medication must be started or increased in dose.
  • In the 'tight' control group, if dBP is ≤80mmHg, then antihypertensive medication must be decreased in dose or discontinued.
  • In both groups, centres will provide their usual care. Data will be collected on potential co-interventions (e.g., hospitalisation, bedrest).

Outcomes:

Primary: Pregnancy loss (miscarriage or ectopic pregnancy, pregnancy termination, stillbirth, or neonatal death) or high level neonatal care for >48 hours in the first 28 days of life or prior to primary hospital discharge, whichever is later.

Secondary: One/more serious maternal complication(s) until six weeks postpartum.

Follow-up:

Compliance (dBP and antihypertensive dose) will be assessed within 4 weeks of randomisation. Outcome data will be collected during the woman's (and baby's) hospital stay for birth (or loss). Women will be contacted 6 to 12 weeks after delivery (or loss) and, for preterm babies, when the baby is at 36 weeks corrected gestational age to enquire about satisfaction with care and any major maternal/neonatal morbidity following hospital discharge.

Study Type

Interventional

Enrollment (Actual)

987

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Corrientes, Argentina
        • Hospital JR Vidal
      • Mendoza, Argentina
        • Hospital LC Lagomaggiore
      • Santa Fe, Argentina
        • Hospital JM Cullen
      • Tucuman, Argentina
        • Hospital Avellaneda
  • Australia
      • Adelaide, Australia
        • Women's and Children's Hospital
      • Ipswich, Australia
        • Ipswich Hospital
      • Subiaco, Australia
        • King Edward Memorial Hospital
      • Subiaco, Australia
        • St John of God Hospital
    • New South Wales
      • Campbelltown, New South Wales, Australia
        • Campbelltown Hospital
      • Liverpool, New South Wales, Australia
        • Liverpool Hospital
  • Brazil
      • Goiania, Brazil
        • Hospital Materno Infantil
      • Niteroi, Brazil
        • Hospital Universitario Antonio Pedro
      • Porto Alegre, Brazil
        • Hospital Sao Lucas - PUCRS
      • Rio de Janeiro, Brazil
        • Maternidade Escola da UFRJ
      • Rio de Janerio, Brazil
        • Clinica Perinatal Barra
      • Rio de Janerio, Brazil
        • Laranjeiras Clinica Perinatal
      • Sao Paulo, Brazil
        • Maternidade Escola de Vila Nova Cachoeirinha
  • Canada
      • Regina, Canada
        • Regina General Hospital
    • Alberta
      • Calgary, Alberta, Canada
        • Calgary Health Region - Foothills Hospital
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital
    • British Columbia
      • Surrey, British Columbia, Canada
        • Jim Pattison Outpatient Care and Surgery Centre
      • Vancouver, British Columbia, Canada
        • St Paul's Hospital
      • Vancouver, British Columbia, Canada, V6H 3N1
        • University of British Columbia, Department of Obstetrics & Gynaecology
      • Vancouver, British Columbia, Canada
        • Children's & Women's Health Centre of BC
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • St Boniface General Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Women's Health Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • IWK Health Centre
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Ottawa Hospital Civic Division
      • Ottawa, Ontario, Canada
        • Ottawa Hospital General Division
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada
        • St Michael's Hospital
      • Toronto, Ontario, Canada
        • Toronto East General Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada
        • Hopital Sainte-Justine
      • Sherbrooke, Quebec, Canada
        • CHUS Fleurimont
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Royal University Hospital
  • Chile
      • Osorno, Chile
        • Hospital Base Osorno
      • Puente Alto, Chile
        • Hospital Dr Sotero del Rio
  • Colombia
      • Cali, Colombia
        • Clinica Materno Infantil Farallones
      • Cali, Colombia
        • Clinica Versalles
      • Cali, Colombia
        • Corporacion Conmfenalco Valle - Universidad Libre
  • Estonia
      • Tartu, Estonia
        • Tartu University Hospital-Women's Clinic
  • Hungary
      • Debrecen, Hungary
        • University of Debrecen
  • Israel
      • Bnei Brak, Israel
        • Ma'ayney Hayeshua Medical Center
      • Hadera, Israel
        • Hillel Yaffe Medical Center
      • Nazareth, Israel
        • Nazareth hospital (EMMS)
  • Jordan
      • Amman, Jordan
        • Islamic Hospital
  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Jeroen Bosch Hospital
      • Almere, Netherlands
        • Flevo ziekenhuis
      • Amersfoort, Netherlands
        • Meander Medisch Centrum
      • Amsterdam, Netherlands
        • OLVG
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Amsterdam, Netherlands
        • VU Medical Center
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Groningen, Netherlands
        • UMCG
      • Haarlem, Netherlands
        • Kennemer Gasthuis Haarlem
      • Hilversum, Netherlands
        • Tergooiziekenhuizen
      • Hoofddorp, Netherlands
        • Spaarne Ziekenhuis
      • Maastricht, Netherlands
        • MUMC Maastricht
      • Nieuwegein, Netherlands
        • St Antonius Ziekenhuis
      • Oss, Netherlands
        • Ziekenhuis Bernhoven
      • Utrecht, Netherlands
        • UMCU
      • Utrecht, Netherlands
        • Diakonessen Ziekenhuis
      • Veldhoven, Netherlands
        • Maxima Medical Centre
      • Zwolle, Netherlands
        • Isala Klinieken Zwolle
  • New Zealand
      • Auckland, New Zealand
        • Waitemata Health-North Shore Hospital
      • Christchurch, New Zealand
        • Christchurch Women's Hospital
  • Poland
      • Gdansk, Poland
        • Medical University of Gdansk
      • Lodz, Poland
        • Polish Mothers Memorial Hospital
      • Poznan, Poland
        • University School of Medical Sciences
  • United Kingdom
      • Basildon, United Kingdom
        • Basildon & Thurrock University Hospital
      • Birmingham, United Kingdom
        • Birmingham Women's Hospital
      • Blackburn, United Kingdom
        • East Lancashire Hospitals NHS Trust
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Chesterfield, United Kingdom
        • Chesterfield Royal Hospital
      • Coventry, United Kingdom
        • University Hospital Coventry and Warwickshire
      • Derby, United Kingdom
        • The Royal Derby Hospital
      • Halifax, United Kingdom
        • Calderdale Royal Hospital
      • Lancashire, United Kingdom
        • Lancashire Teaching Hospitals NHS Foundation Trust
      • Lancaster, United Kingdom
        • Royal Lancaster Infirmary
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • Liverpool, United Kingdom
        • Liverpool Women's Hospital
      • London, United Kingdom
        • Queen Elizabeth Hospital
      • London, United Kingdom
        • Guy's & St Thomas' Hospital
      • Manchester, United Kingdom
        • St Mary's Hospital
      • Newcastle upon Tyne, United Kingdom
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom
        • Nottingham City Hospital
      • Nottingham, United Kingdom
        • Queen's Medical Centre
      • Nottinghamshire, United Kingdom
        • King's Mill Hospital
      • Ormskirk, United Kingdom
        • Southport & Ormskirk Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust
      • Slough, United Kingdom
        • Wexham Park Hospital
      • Sunderland, United Kingdom
        • City Hospitals Sunderland NHS Foundation Trust
      • Swansea, United Kingdom
        • Singleton Hospital
      • Warwickshire, United Kingdom
        • South Warwickshire NHS Trust
      • Wolverhampton, United Kingdom
        • New Cross Hospital
      • York, United Kingdom
        • York District Hospital
  • United States
    • Connecticut
      • New Haven, Connecticut, United States
        • Yale-New Haven Hospital
    • Kentucky
      • Louisville, Kentucky, United States
        • Norton Hospital Downtown
      • Louisville, Kentucky, United States
        • Norton Suburban Hospital
    • Massachusetts
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess
    • Minnesota
      • Minneapolis, Minnesota, United States
        • University of Minnesota
    • New Jersey
      • Camden, New Jersey, United States
        • Cooper University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina
      • Greenville, North Carolina, United States
        • East Carolina University
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
    • Wisconsin
      • Madison, Wisconsin, United States
        • Meriter Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 'Less tight' control.
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Procedure: 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.
ACTIVE_COMPARATOR: 'Tight' control.
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Loss or NICU Admission for Greater Than 48 Hours
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Maternal Complications Measured up to 6 Weeks Postpartum
Time Frame: 6 weeks

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)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)
Sunnybrook Research Institute

Investigators

  • Principal Investigator: Laura A Magee, MD, FRCPC, MSc, FACP, The University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (ESTIMATE)

September 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2017

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H08-00882
  • MCT-87522 (OTHER_GRANT: CIHR)
  • 07-3431 (OTHER: UBC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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