Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00831831 |
| Other study ID # |
H07-02007 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 3
|
| First received |
January 27, 2009 |
| Last updated |
July 11, 2012 |
| Start date |
April 2008 |
| Est. completion date |
December 2011 |
Study information
| Verified date |
July 2012 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Health Canada |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Protocol RESEARCH PLAN
Title: Massage Therapy and Labour Outcomes: a Randomized Controlled Trial
1. Goal and Objectives The overall purpose of this project is to evaluate whether or not,
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.
Specific Aims Our specific aim is to randomly assign women who identify as having been
exposed to intimate partner violence to receive either usual care or a targeted safety
planning intervention in order to study effect of safety planning on perinatal outcomes.
Research Questions
We will compare 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:
1. antepartum hemorrhage
2. antepartum infection
3. low birthweight
4. perinatal death
Hypotheses We hypothesize that, among women who disclose exposure to intimate partner
violence during pregnancy, those receive a targeted intervention of safety planning and
referral will experience a reduction in incidence of low birthweight babies compared to
those who receive standard care consisting of a resource card and the offer of referral to a
social worker.
2.0 Design This is a randomized controlled trial. After providing informed, written consent,
each participant will be randomly assigned to a) usual care or b) a targeted intervention
program. Randomization will take place by pulling a consecutively numbered card from a box,
within which a concealed allocation is written.
Study sample Our study sample will include pregnant women how indicate concern about
intimate partner violence to their antenatal care providers at Surrey Memorial Hospital and
BC Women's Hospital.
Study Setting The study will take place at Surrey Memorial Hospital an BC Women's Hospital
in Vancouver, in British Columbia, Canada.
Recruitment During our proposed study, women who indicate to their antenatal provider that
they are concerned about violence will be asked if they would like to receive some
information about a study related to women's safety during pregnancy. If women are
agreeable, the caregiver will provide them with a recruitment brochure. Women will sign
their name on this brochure if they are interested and indicate how they would like to be
contacted. A study research assistant will contact potential participants in a way that they
have indicated is safe, and explain the study in detail.
Randomization Randomization will take place immediately after obtaining written consent. A
statistical software package (SPSS - Statistical Program for the Social Sciences) will be
utilized to randomly assign sequential numbers to one of the two treatment arms. Cards will
be numbered sequentially and labelled with the treatment allocation. These cards will be
placed in opaque envelopes in a box which will be kept in a locked cupboard to which the
recruitment nurse holds the key. Envelopes will be opened in sequential order for each study
participant after written informed consent has been obtained. A log book will be maintained
by the research assistant detailing the patients approached, their decision to participate
or not, randomization number, and allocation.
Protocol Usual care will consist of a resource card providing information about a variety of
community agencies that support women, including women experiencing violence. and the
opportunity to meet with a hospital social worker for referral to relevant community
agencies.
The intervention program be provided by community health nurses and will consist of:
i) ensuring that the woman has telephone numbers for community agencies serving women who
experience violence, in particular, agencies that serve women of their cultural background
with language-specific services; ii) knowledge of how to contact a women's shelter, and if
desired, assistance in contacting the shelter and negotiating admission; iii) offer of
referral to a hospital social worker with translation services available if necessary; iv)
information on Canadian law with respect to violence perpetrated by an intimate partner; v)
information on how to access outreach support to apply for welfare and/or skills assessment
and retraining; vi) information on how to access outreach support to access emergency funds
from a provincial employment and assistance program vii) safety planning, including a)
identification of a method of escape from the home (a "rescue" driver, call to a shelter,
taxi, extra set of car keys for family car); b) an "escape bundle" kept outside the home
including important documents, money, etc.; c) identification of an escape route out of the
house (unlatched window, for example); and d) recruitment of a friend or neighbour who can
come over in the event that a code word is used over the phone.
Women will be asked to complete two measures of violence exposure at the time of enrollment
and on a monthly basis thereafter.
Study Outcomes Our study outcomes include pregnancy complications and newborn outcomes.
Pregnancy complications will include hemorrhage during the 2nd or 3rd trimester of
pregnancy, intrauterine growth restriction, preterm labour (prior to 37 weeks), preterm
delivery, and chorioamnionitis (infection of the placenta and membranes). Our primary
newborn outcome is low birthweight (less than 2500g). Low birthweight will be further
subdivided into preterm birth and/or birthweight within the 10th percentile for gestational
age and sex by provincial standards. We will also document perinatal death.
