Skip to main content
OpenTrials
Completed

NCT Number: NCT00187395

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Transient Hypertension, Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre

Toronto, Ontario, M5G 1N8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

Primary outcomes

  1. Mean dBP at 28, 32 and 36 weeks gestation

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Control of Hypertension in Pregnancy Study: A Pilot Trial

Important dates

Study start
2003
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.