Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly (TOPFA)
Primary Purpose
Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
supportive call
Sponsored by
About this trial
This is an interventional supportive care trial for Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly focused on measuring termination fetal anomaly, psychological sequelae pregnancy termination for anomalies, supportive follow-up pregnancy termination anomalies
Eligibility Criteria
Inclusion Criteria:
- women over 18 years of age undergoing termination of pregnancy for fetal anomaly at Mount Sinai Hospital, Toronto
- fluent in oral and written English
- able to understand the nature of the study
- can provide informed consent
- can be reached by telephone
Exclusion Criteria:
-women who are currently seeing a therapist or undergoing psychiatric care, and women who do not meet all of the inclusion criteria
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months.
Subjects in the control group will receive no intervention.
Outcomes
Primary Outcome Measures
At time of induction of labour and at 3, 6, and 12 months post-TOPFA: scores on the Beck Depression Inventory, the Impact of Events Scale, the Lang and Goulet Hardiness Scale,the Relationship Scales Questionnaire
Secondary Outcome Measures
Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA
Full Information
NCT ID
NCT00576212
First Posted
December 17, 2007
Last Updated
July 29, 2009
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00576212
Brief Title
Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly
Acronym
TOPFA
Official Title
The Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely, prior to enrollment of first participant.
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study focuses on women undergoing termination of pregnancy for fetal anomalies (TOPFA). Psychological consequences of such terminations may be even greater than those associated with spontaneous losses of pregnancy because of shame and guilt which can result in social isolation. Currently, there is little support for women after they have left hospital. In this study, 50 TOPFA women will be randomly assigned to an intervention group and 50 to a control group. By completing four questionnaires at the time of induction of labour, total sample will be assessed for depression, stress and "hardiness"; they will be reassessed at 3, 6, and 12 months. Total sample will be interviewed by phone at 6 and 12 months. We hope to determine whether a telephone-based intervention (a biweekly supportive call) can decrease the emotional distress experienced by women undergoing termination of pregnancy.
Detailed Description
We hypothesize that: 1)women in the intervention group will show lower rates of depression and stress and a significant increase in hardiness over time at 6 and 12 months post-termination compared with the control group; 2) women who score low on hardiness initially will experience more psychological distress at 6 and 12 months than subjects who score higher initially, irrespective of group; 3) women who have anxious/avoidant attachment styles will not show an improvement in psychological distress over time, irrespective of group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly
Keywords
termination fetal anomaly, psychological sequelae pregnancy termination for anomalies, supportive follow-up pregnancy termination anomalies
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months.
Arm Title
B
Arm Type
No Intervention
Arm Description
Subjects in the control group will receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
supportive call
Intervention Description
Each subject in the intervention group will receive a 10 minute (or longer) biweekly telephone call from a psychologist intended to provide non-judgemental support to TOPFA women with the aim of reducing depression, guilt, isolation, shame, marital discord, and other common psychological sequelae of termination for fetal anomalies.
Primary Outcome Measure Information:
Title
At time of induction of labour and at 3, 6, and 12 months post-TOPFA: scores on the Beck Depression Inventory, the Impact of Events Scale, the Lang and Goulet Hardiness Scale,the Relationship Scales Questionnaire
Time Frame
One year
Secondary Outcome Measure Information:
Title
Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women over 18 years of age undergoing termination of pregnancy for fetal anomaly at Mount Sinai Hospital, Toronto
fluent in oral and written English
able to understand the nature of the study
can provide informed consent
can be reached by telephone
Exclusion Criteria:
-women who are currently seeing a therapist or undergoing psychiatric care, and women who do not meet all of the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen Sloan, PhD MD FRCP
Organizational Affiliation
Mount Sinai Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly
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