The CHIPS Trial (Control of Hypertension In Pregnancy Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Sunnybrook Research Institute
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01192412
First received: August 30, 2010
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Gestational Hypertension
Procedure: Intervention is blood pressure management approach
Procedure: Intervention is blood pressure management approach.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The CHIPS Trial (Control of Hypertension In Pregnancy Study)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Pregnancy loss or NICU admission for greater than 48 hours [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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 Measures:
  • Serious maternal complications measured up to 6 weeks postpartum [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

    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)


Estimated Enrollment: 1028
Study Start Date: April 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192412

  Hide Study Locations
Locations
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States
United States, Kentucky
Norton Hospital Downtown
Louisville, Kentucky, United States
Norton Suburban Hospital
Louisville, Kentucky, United States
United States, Massachusetts
Beth Israel Deaconess
Boston, Massachusetts, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
United States, Wisconsin
Meriter Hospital
Madison, Wisconsin, United States
Argentina
Hospital JR Vidal
Corrientes, Argentina
Hospital LC Lagomaggiore
Mendoza, Argentina
Hospital JM Cullen
Santa Fe, Argentina
Hospital Avellaneda
Tucuman, Argentina
Australia, New South Wales
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
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
Brazil
Hospital Materno Infantil
Goiania, Brazil
Hospital Universitario Antonio Pedro
Niteroi, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Brazil
Maternidade Escola da UFRJ
Rio de Janeiro, Brazil
Laranjeiras Clinica Perinatal
Rio de Janerio, Brazil
Clinica Perinatal Barra
Rio de Janerio, Brazil
Maternidade Escola de Vila Nova Cachoeirinha
Sao Paulo, Brazil
Canada, Alberta
Calgary Health Region - Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia, Canada
St Paul's Hospital
Vancouver, British Columbia, Canada
Children's & Women's Health Centre of BC
Vancouver, British Columbia, Canada
University of British Columbia, Department of Obstetrics & Gynaecology
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Manitoba
St Boniface General Hospital
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Women's Health Centre
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
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
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada
Hopital Sainte-Justine
Montreal, Quebec, Canada
CHUS Fleurimont
Sherbrooke, Quebec, Canada
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Canada
Regina General Hospital
Regina, Canada
Chile
Hospital Base Osorno
Osorno, Chile
Hospital Dr Sotero del Rio
Puente Alto, Chile
Colombia
Corporacion Conmfenalco Valle - Universidad Libre
Cali, Colombia
Clinica Versalles
Cali, Colombia
Clinica Materno Infantil Farallones
Cali, Colombia
Estonia
Tartu University Hospital-Women's Clinic
Tartu, Estonia
Hungary
University of Debrecen
Debrecen, Hungary
Israel
Ma'ayney Hayeshua Medical Center
Bnei Brak, Israel
Hillel Yaffe Medical Center
Hadera, Israel
Nazareth Hospital (EMMS)
Nazareth, Israel
Jordan
Islamic Hospital
Amman, Jordan
Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Flevo ziekenhuis
Almere, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
VU Medical Center
Amsterdam, Netherlands
Academic Medical Center
Amsterdam, Netherlands
OLVG
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
UMCU
Utrecht, Netherlands
Diakonessen Ziekenhuis
Utrecht, Netherlands
Maxima Medical Centre
Veldhoven, Netherlands
Isala Klinieken Zwolle
Zwolle, Netherlands
New Zealand
Waitemata Health-North Shore Hospital
Auckland, New Zealand
Christchurch Women's Hospital
Christchurch, New Zealand
Poland
Medical University of Gdansk
Gdansk, Poland
Polish Mothers Memorial Hospital
Lodz, Poland
University School of Medical Sciences
Poznan, Poland
United Kingdom
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
Queen Elizabeth Hospital
London, United Kingdom
Guy's & St Thomas' Hospital
London, United Kingdom
St Mary's Hospital
Manchester, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Queen's Medical Centre
Nottingham, United Kingdom
Nottingham City Hospital
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
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Sunnybrook Research Institute
Investigators
Principal Investigator: Laura A Magee, MD, FRCPC, MSc, FACP The University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01192412     History of Changes
Obsolete Identifiers: NCT01081171
Other Study ID Numbers: H08-00882, MCT-87522, 07-3431
Study First Received: August 30, 2010
Last Updated: October 21, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
hypertension
pregnancy
antihypertensive therapy
perinatal outcome
maternal outcome
Non-severe, non-proteinuric pre-existing or gestational hypertension in pregnancy

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014