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

Transient Hypertension, Pregnancy Clinical Trial

Official title:

Control of Hypertension in Pregnancy Study: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187395
• Other study ID #: MCT- 59755
• Secondary ID: ISRCTN57277508
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 9, 2009
• Start date: April 2003
• Est. completion date: December 2005

Study information

• Verified date: September 2005
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Transient Hypertension, Pregnancy

Intervention

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

Locations

Country	Name	City	State
Canada	Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean dBP at 28, 32 and 36 weeks gestation
Secondary	Clinician compliance with treatment protocols; women's satisfaction with care.

External Links

•   CHIPS Pilot Trial website