MedTrace Logo

The CHIPS Trial (Control of Hypertension In Pregnancy Study)

NCT01192412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 987

Last updated 2017-01-11

Study results available
· View outcomes & findings →

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 whether 'less tight' control (aiming for a diastolic blood pressure \[dBP\] of 100 mmHg), compared with 'tight' control (aiming for a diastolic blood pressure \[dBP\] of 85 mmHg) can decrease the risks of adverse baby outcomes without increasing the risk of problems for the mother.

Conditions

  • Gestational Hypertension

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Sunnybrook Research Institute

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Laura A Magee, MD, FRCPC, MSc, FACP · The University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Estonia
  • Hungary
  • Israel
  • Jordan
  • Netherlands
  • New Zealand
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01192412 on ClinicalTrials.gov