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

NCT00831831 | Withdrawn Phase 3

• 1 other identifier: H07-02007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

perinatal; intimate partner violence; randomized controlled trial; preterm; hemorrhage; safety

Outcome Measures

Primary Outcomes (1)

• Intrauterine Growth Restriction.

  During pregnancy

Secondary Outcomes (1)

• Hemorrhage during the 2nd or 3rd trimester of pregnancy, preterm labour, preterm delivery, and chorioamnionitis.

  During pregnancy

Interventions

Safety planning BEHAVIORAL

See detailed description

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Foundation for Women's Health: collaborator

Study Sites (1)

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

Location

MeSH Terms

Conditions

Premature Birth; Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patti Janssen, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 29, 2009
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2011
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

CA (1)