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Can Safety Planning Improve Perinatal Outcomes Among Pregnant Women Exposed to Intimate Partner Violence?

NCT00831831 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-07-12

No results posted yet for this study

Summary

OBJECTIVE: To investigate if, among women exposed to physical violence during pregnancy, does a targeted intervention consisting of safety planning and referral to community advocacy services decrease rates of adverse perinatal outcomes including antepartum hemorrhage or infection, low birthweight, and perinatal death.

DESIGN: A randomized controlled trial. SETTING: Surrey Memorial Hospital and BC Women's Hospital in British Columbia, Canada PARTICIPANTS: Pregnant women experiencing intimate partner violence MAIN OUTCOME MEASURES: We are interested in perinatal outcomes such as birth weight and preterm labour.

DATA ANALYSIS: Outcomes for women in each arm of the trial will be compared in an intention to treat analysis. Changes in risk for adverse outcomes associated with the study intervention will be estimated by the odds ratios calculated by the logistic regression model.

Conditions

  • Perinatal Outcomes

Interventions

BEHAVIORAL

Safety planning

See detailed description

Sponsors & Collaborators

  • Canadian Foundation for Women's Health

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Patti Janssen, Ph.D · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-01-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

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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 NCT00831831 on ClinicalTrials.gov