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

This study has been withdrawn prior to enrollment.
(The team wasn't able to work effectively with the social worker at the site)
Sponsor:
Collaborator:
Canadian Foundation for Women's Health
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00831831
First received: January 27, 2009
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Perinatal Outcomes
Behavioral: Safety planning
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Can Safety Planning Improve Perinatal Outcomes Among Pregnant Women Exposed to Intimate Partner Violence?

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Intrauterine Growth Restriction. [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemorrhage during the 2nd or 3rd trimester of pregnancy, preterm labour, preterm delivery, and chorioamnionitis. [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Safety planning
    See detailed description
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant
  • Women
  • Experiencing intimate partner violence
  • Able to speak English or Punjabi.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831831

Locations
Canada, British Columbia
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V 1Z2
Sponsors and Collaborators
University of British Columbia
Canadian Foundation for Women's Health
Investigators
Principal Investigator: Patti Janssen, Ph.D University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00831831     History of Changes
Other Study ID Numbers: H07-02007
Study First Received: January 27, 2009
Last Updated: July 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
perinatal
intimate partner violence
randomized controlled trial
preterm
hemorrhage
safety

ClinicalTrials.gov processed this record on July 22, 2014