CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial

This study has been completed.

Sponsor:

Collaborator:

Canadian Institutes of Health Research (CIHR)

Information provided by:

Sunnybrook Health Sciences Centre

ClinicalTrials.gov Identifier:

NCT00187395

First received: September 13, 2005

Last updated: March 9, 2009

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

March 9, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Mean dBP at 28, 32 and 36 weeks gestation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00187395 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinician compliance with treatment protocols; women's satisfaction with care.

Original Secondary Outcome Measures ^ICMJE

Clinician compliance with treatment protocols; women’s satisfaction with care.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial

Official Title ^ICMJE

Control of Hypertension in Pregnancy Study: A Pilot Trial

Brief Summary

Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to first determine whether clinicians will comply with the interventions of 'less tight' and 'tight' control of dBP, and whether the interventions will result in differences in mean dBP between groups. A pilot will also allow us to confirm the ability of centres to identify eligible women and the willingness of women to join CHIPS.

Detailed Description

To determine whether 'less tight' control of mild-moderate non-proteinuric maternal hypertension, aiming for a diastolic blood pressure (dBP) of 100mmHg, can decrease the risks of adverse perinatal outcome without increasing maternal risk compared with 'tight' control, aiming for a dBP of 85mmHg.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Transient Hypertension, Pregnancy

Intervention ^ICMJE

Procedure: Randomized to either a 'less tight' group or a 'tight' group

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

Enrollment ^ICMJE

132

Completion Date

December 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

dBP 90-109mmHg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks.

Exclusion Criteria:

dBP consistently < 85mmHg by home BP monitoring; severe systolic hypertension; proteinuria; contraindication to either arm of the trial or to prolongation of pregnancy; or known lethal/major fetal anomaly.

Gender

Female

Ages

18 Years to 48 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00187395

Other Study ID Numbers ^ICMJE

MCT- 59755, ISRCTN57277508

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sunnybrook Health Sciences Centre

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)

Investigators ^ICMJE

Principal Investigator:

Laura Magee, MD

Sunnybrook Health Sciences Centre

Information Provided By

Sunnybrook Health Sciences Centre

Verification Date

September 2005

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

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