Status:
COMPLETED
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Sunnybrook Research Institute
Conditions:
Gestational Hypertension
Eligibility:
FEMALE
Phase:
NA
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 whethe...
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) ve...
Eligibility Criteria
Inclusion
- 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)
- dBP of 90 - 105 mmHg if NOT TAKING antihypertensive therapy, or dBP of 85 - 105 mmHg if TAKING antihypertensive therapy
- Live foetus (confirmed by Doptone assessment of foetal heart tones within one week before randomisation)
- Gestational age 14 - 33+6 weeks (as measured by last menstrual period or dating ultrasound)
Exclusion
- Severe systolic hypertension (defined as a systolic blood pressure \[sBP\] greater than or equal to 160 mmHg at randomisation)
- 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+)
- Use of an angiotensin converting enzyme (ACE) inhibitor at greater than or equal to 14+0 weeks' gestation
- Contraindication to either arm of the trial or to pregnancy prolongation
- Known multiple gestation
- Known lethal or major foetal anomaly
- Plan to terminate pregnancy
- Prior participation in CHIPS
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
987 Patients enrolled
Trial Details
Trial ID
NCT01192412
Start Date
April 1 2009
End Date
February 1 2014
Last Update
January 11 2017
Active Locations (111)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale-New Haven Hospital
New Haven, Connecticut, United States
2
Norton Hospital Downtown
Louisville, Kentucky, United States
3
Norton Suburban Hospital
Louisville, Kentucky, United States
4
Beth Israel Deaconess
Boston, Massachusetts, United States