Can Safety Planning Improve Perinatal Outcomes Among Pregnant Women Exposed to Intimate Partner Violence?
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.
|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?|
- Intrauterine Growth Restriction. [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]
- Hemorrhage during the 2nd or 3rd trimester of pregnancy, preterm labour, preterm delivery, and chorioamnionitis. [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Behavioral: Safety planning
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831831
|Canada, British Columbia|
|Surrey Memorial Hospital|
|Surrey, British Columbia, Canada, V3V 1Z2|
|Principal Investigator:||Patti Janssen, Ph.D||University of British Columbia|