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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gestational Hypertension
Interventions Procedure: Intervention is blood pressure management approach
Procedure: Intervention is blood pressure management approach.
Enrollment 987
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 'Less Tight' Control. 'Tight' Control.
Hide Arm/Group Description

The diastolic blood pressure (dBP) treatment goal is 100 mmHg.

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.

The diastolic blood pressure (dBP) treatment goal is 85 mmHg.

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.
Period Title: Overall Study
Started 497 490
Completed 493 488
Not Completed 4 2
Reason Not Completed
Lost to Follow-up             2             1
Withdrawal by Subject             2             1
Arm/Group Title 'Less Tight' Control. 'Tight' Control. Total
Hide Arm/Group Description

The diastolic blood pressure (dBP) treatment goal is 100 mmHg.

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.

The diastolic blood pressure (dBP) treatment goal is 85 mmHg.

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.

 Total of all reporting groups
Overall Number of Baseline Participants 497 490 987
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 497 participants 490 participants 987 participants
34.0  (5.7) 33.7  (5.8) 33.8  (5.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 497 participants 490 participants 987 participants
Female
497
 100.0%
490
 100.0%
987
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Body-mass index   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 497 participants 490 participants 987 participants
<18.5 kg/m^2 1 2 3
18.5-24.9 kg/m^2 116 112 228
25.0-29.9 kg/m^2 131 135 266
≥30.0 kg/m^2 245 236 481
[1]
Measure Description: Available in 493 women in 'Less-tight' control, and 485 women in 'Tight' control
Cigarette smoking during this pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 497 participants 490 participants 987 participants
35 28 63
Nulliparous   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 497 participants 490 participants 987 participants
161 168 329
[1]
Measure Description: Women who were never pregnant before (i.e., first pregnancy)
Weeks of gestation  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 497 participants 490 participants 987 participants
23.7  (6.3) 24.2  (6.3) 23.9  (6.3)
Type of nonproteinuric hypertension  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 497 participants 490 participants 987 participants
Preexisting hypertension 371 365 736
Gestational hypertension 126 125 251
Prior blood pressure ≥160 mm Hg systolic or ≥110 mm Hg diastolic during this pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 497 participants 490 participants 987 participants
82 59 141
Antihypertensive medication at enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 497 participants 490 participants 987 participants
279 287 566
Blood pressure within 1 wk before randomization  
Mean (Standard Deviation)
Unit of measure:  mmHg
 Number Analyzed 497 participants 490 participants 987 participants
Systolic 140.4  (9.7) 139.7  (9.8) 140.1  (9.8)
Diastolic 92.6  (4.8) 92.2  (5.2) 92.4  (5.0)
Currently monitoring blood pressure at home  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 497 participants 490 participants 987 participants
185 194 379
Gestational diabetes at enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 497 participants 490 participants 987 participants
32 31 63
1.Primary Outcome
Title Pregnancy Loss or NICU Admission for Greater Than 48 Hours
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 'Less Tight' Control. 'Tight' Control.
Hide Arm/Group Description:

The diastolic blood pressure (dBP) treatment goal is 100 mmHg.

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.

The diastolic blood pressure (dBP) treatment goal is 85 mmHg.

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.
Overall Number of Participants Analyzed 493 488
Measure Type: Number
Unit of Measure: participants
155 150
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 'Less Tight' Control., 'Tight' Control.
Comments We estimated that with a sample size of 514 per group, the study would have 80% power, at a two-tailed alpha level of 0.05, assuming primary outcome rates of 33% in the tight-control group and 25% in the less-tight-control group, a 10% rate of crossover, a 1% loss to follow-up, and two interim analyses, as calculated with the chi-square test with the use of East software (Cytel) and the Lan–DeMets spending function with O’Brien–Fleming–type boundaries for early stopping.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.77 to 1.35
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Serious Maternal Complications Measured up to 6 Weeks Postpartum
Hide Description

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)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 'Less Tight' Control. 'Tight' Control.
Hide Arm/Group Description:

The diastolic blood pressure (dBP) treatment goal is 100 mmHg.

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.

The diastolic blood pressure (dBP) treatment goal is 85 mmHg.

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.
Overall Number of Participants Analyzed 493 488
Measure Type: Number
Unit of Measure: participants
18 10
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 'Less Tight' Control., 'Tight' Control.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.74
Confidence Interval (2-Sided) 95%
0.79 to 3.84
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 'Less Tight' Control. 'Tight' Control.
Hide Arm/Group Description

The diastolic blood pressure (dBP) treatment goal is 100 mmHg.

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.

The diastolic blood pressure (dBP) treatment goal is 85 mmHg.

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.
All-Cause Mortality
'Less Tight' Control. 'Tight' Control.
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
'Less Tight' Control. 'Tight' Control.
Affected / at Risk (%) Affected / at Risk (%)
Total   155/493 (31.44%)   150/488 (30.74%) 
Blood and lymphatic system disorders     
Transfusion  16/493 (3.25%)  8/488 (1.64%) 
Cardiac disorders     
Uncontrolled hypertension  0/493 (0.00%)  0/488 (0.00%) 
Nervous system disorders     
Transient ischemic attack or stroke  0/493 (0.00%)  1/488 (0.20%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy loss  15/493 (3.04%)  15/488 (3.07%) 
Miscarriage  0/493 (0.00%)  1/488 (0.20%) 
Ectopic pregnancy  0/493 (0.00%)  0/488 (0.00%) 
Elective termination  1/493 (0.20%)  1/488 (0.20%) 
Perinatal death  14/493 (2.84%)  11/488 (2.25%) 
Stillbirth  12/493 (2.43%)  7/488 (1.43%) 
Neonatal death  2/493 (0.41%)  4/488 (0.82%) 
High-level neonatal care for >48hr  141/480 (29.38%)  139/479 (29.02%) 
Birthweight <10th percentile  79/491 (16.09%)  96/488 (19.67%) 
Birthweight <3rd percentile  23/491 (4.68%)  26/488 (5.33%) 
Renal and urinary disorders     
Renal failure  0/493 (0.00%)  1/488 (0.20%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema  2/493 (0.41%)  1/488 (0.20%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
'Less Tight' Control. 'Tight' Control.
Affected / at Risk (%) Affected / at Risk (%)
Total   241/493 (48.88%)   223/488 (45.70%) 
Cardiac disorders     
Severe hypertension  200/493 (40.57%)  134/488 (27.46%) 
Pregnancy, puerperium and perinatal conditions     
Placental abruption  11/493 (2.23%)  11/488 (2.25%) 
Preeclampsia  241/493 (48.88%)  223/488 (45.70%) 
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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Laura A. Magee
Organization: St. George's, University of London
Phone: +442086729944 ext 52621
EMail: LMagee@sgul.ac.uk
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01192412    
Obsolete Identifiers: NCT01081171
Other Study ID Numbers: H08-00882
MCT-87522 ( Other Grant/Funding Number: CIHR )
07-3431 ( Other Identifier: UBC )
First Submitted: August 30, 2010
First Posted: September 1, 2010
Results First Submitted: August 30, 2016
Results First Posted: January 11, 2017
Last Update Posted: January 11, 2017