Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly (TOPFA)
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|ClinicalTrials.gov Identifier: NCT00576212|
Recruitment Status : Withdrawn (Study halted prematurely, prior to enrollment of first participant.)
First Posted : December 19, 2007
Last Update Posted : July 30, 2009
|Condition or disease||Intervention/treatment|
|Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly||Behavioral: supportive call|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||September 2007|
|Estimated Study Completion Date :||September 2009|
Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months.
Behavioral: supportive call
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.
No Intervention: B
Subjects in the control group will receive no intervention.
- 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 ]
- Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576212
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Eileen Sloan, PhD MD FRCP||Mount Sinai Hospital, Canada|