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Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly (TOPFA)

This study has been withdrawn prior to enrollment.
(Study halted prematurely, prior to enrollment of first participant.)
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00576212
First received: December 17, 2007
Last updated: July 29, 2009
Last verified: July 2009

December 17, 2007
July 29, 2009
September 2007
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00576212 on ClinicalTrials.gov Archive Site
Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA [ Time Frame: One year ]
Same as current
Not Provided
Not Provided
 
Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly
The Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly
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.
  • Experimental: A
    Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months.
    Intervention: Behavioral: supportive call
  • No Intervention: B
    Subjects in the control group will receive no intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
September 2009
Not Provided

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

Female
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00576212
07-0157-E
No
Not Provided
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Eileen Sloan, PhD MD FRCP Mount Sinai Hospital, Toronto
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP