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The CHIPS Trial (Control of Hypertension In Pregnancy Study)

This study has been completed.
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: November 15, 2016
Last verified: November 2016
Results First Received: August 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gestational Hypertension
Interventions: Procedure: Intervention is blood pressure management approach
Procedure: Intervention is blood pressure management approach.

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
'Less Tight' Control.

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.

'Tight' Control.

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.


Participant Flow:   Overall Study
    'Less Tight' Control.   'Tight' Control.
STARTED   497   490 
COMPLETED   493   488 
NOT COMPLETED   4   2 
Lost to Follow-up                2                1 
Withdrawal by Subject                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
'Less Tight' Control.

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.

'Tight' Control.

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 Total of all reporting groups

Baseline Measures
   'Less Tight' Control.   'Tight' Control.   Total 
Overall Participants Analyzed 
[Units: Participants]
 497   490   987 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.0  (5.7)   33.7  (5.8)   33.8  (5.8) 
Gender 
[Units: Participants]
Count of 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] 
[Units: 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] Available in 493 women in 'Less-tight' control, and 485 women in 'Tight' control
Cigarette smoking during this pregnancy 
[Units: Participants]
 35   28   63 
Nulliparous [1] 
[Units: Participants]
 161   168   329 
[1] Women who were never pregnant before (i.e., first pregnancy)
Weeks of gestation 
[Units: Weeks]
Mean (Standard Deviation)
 23.7  (6.3)   24.2  (6.3)   23.9  (6.3) 
Type of nonproteinuric hypertension 
[Units: 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 
[Units: Participants]
 82   59   141 
Antihypertensive medication at enrollment 
[Units: Participants]
 279   287   566 
Blood pressure within 1 wk before randomization 
[Units: mmHg]
Mean (Standard Deviation)
     
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 
[Units: Participants]
 185   194   379 
Gestational diabetes at enrollment 
[Units: Participants]
 32   31   63 


  Outcome Measures
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1.  Primary:   Pregnancy Loss or NICU Admission for Greater Than 48 Hours   [ Time Frame: 6 weeks ]

2.  Secondary:   Serious Maternal Complications Measured up to 6 Weeks Postpartum   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information
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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:  
Name/Title: Dr. Laura A. Magee
Organization: St. George's, University of London
phone: +442086729944 ext 52621
e-mail: LMagee@sgul.ac.uk


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01192412     History of Changes
Obsolete Identifiers: NCT01081171
Other Study ID Numbers: H08-00882
MCT-87522 ( Other Grant/Funding Number: CIHR )
07-3431 ( Other Identifier: UBC )
Study First Received: August 30, 2010
Results First Received: August 30, 2016
Last Updated: November 15, 2016
Health Authority: Canada: Health Canada