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The CHIPS Trial (Control of Hypertension In Pregnancy Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01192412
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Sunnybrook Research Institute
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE August 30, 2010
First Posted Date  ICMJE September 1, 2010
Results First Submitted Date  ICMJE August 30, 2016
Results First Posted Date  ICMJE January 11, 2017
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE April 2009
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CHIPS Trial (Control of Hypertension In Pregnancy Study)
Official Title  ICMJE The CHIPS Trial (Control of Hypertension In Pregnancy Study)
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gestational Hypertension
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: 'Less tight' control.
    The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
    Intervention: Procedure: Intervention is blood pressure management approach
  • Active Comparator: 'Tight' control.
    The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
    Intervention: Procedure: Intervention is blood pressure management approach.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2015)
987
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2010)
1028
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Chile,   Colombia,   Estonia,   Hungary,   Israel,   Jordan,   Netherlands,   New Zealand,   Poland,   United Kingdom,   United States
Removed Location Countries Equatorial Guinea,   Qatar
 
Administrative Information
NCT Number  ICMJE NCT01192412
Other Study ID Numbers  ICMJE H08-00882
MCT-87522 ( Other Grant/Funding Number: CIHR )
07-3431 ( Other Identifier: UBC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of British Columbia
Original Responsible Party Dr. Laura Ann Magee, The University of British Columbia
Current Study Sponsor  ICMJE University of British Columbia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Sunnybrook Research Institute
Investigators  ICMJE
Principal Investigator: Laura A Magee, MD, FRCPC, MSc, FACP The University of British Columbia
PRS Account University of British Columbia
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP