CHIPS (Control of Hypertension in Pregnancy Study): A Pil... | NCT00187395

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

NCT00187395

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Mar 12, 2009Estimated

Enrollment

132

Phase

Not Applicable

Conditions

Transient Hypertension, Pregnancy

Interventions

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

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ISRCTN57277508

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2009

Last Update Posted Date

Mar 12, 2009Estimated

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132

Name	Type	Description	Arm Group Labels	Other Names
Randomized to either a 'less tight' group or a 'tight' group	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean dBP at 28, 32 and 36 weeks gestation

Secondary Outcomes

Measure	Description	Time Frame
Clinician compliance with treatment protocols; women's satisfaction with care.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Magee, MD	Sunnybrook Health Sciences Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre		Toronto	Ontario	M5G 1N8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D006973	Hypertension

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided