The CHIPS Trial (Control of Hypertension In Pregnancy Study)
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ClinicalTrials.gov Identifier: NCT01192412 |
Recruitment Status :
Completed
First Posted : September 1, 2010
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
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Study Type | Interventional |
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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. |
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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 | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 497 participants | 490 participants | 987 participants | |
Female |
497 100.0%
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490 100.0%
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987 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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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
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Cigarette smoking during this pregnancy
Measure Type: Number Unit of measure: Participants |
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Number Analyzed | 497 participants | 490 participants | 987 participants | |
35 | 28 | 63 | ||
Nulliparous
[1] Measure Type: Number Unit of measure: Participants |
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Number Analyzed | 497 participants | 490 participants | 987 participants | |
161 | 168 | 329 | ||
[1]
Measure Description: Women who were never pregnant before (i.e., first pregnancy)
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Weeks of gestation
Mean (Standard Deviation) Unit of measure: Weeks |
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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 |
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Number Analyzed | 497 participants | 490 participants | 987 participants | |
82 | 59 | 141 | ||
Antihypertensive medication at enrollment
Measure Type: Number Unit of measure: Participants |
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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 |
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Number Analyzed | 497 participants | 490 participants | 987 participants | |
185 | 194 | 379 | ||
Gestational diabetes at enrollment
Measure Type: Number Unit of measure: Participants |
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Number Analyzed | 497 participants | 490 participants | 987 participants | |
32 | 31 | 63 |
Name/Title: | Dr. Laura A. Magee |
Organization: | St. George's, University of London |
Phone: | +442086729944 ext 52621 |
EMail: | LMagee@sgul.ac.uk |
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 |