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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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.


Condition Intervention
Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly
 Behavioral: supportive call

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

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 [ Time Frame: One year ]

Secondary Outcome Measures:
  • Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA [ Time Frame: One year ]

Estimated Enrollment: 100
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Arms Assigned Interventions
Experimental: A
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576212

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Eileen Sloan, PhD MD FRCP Mount Sinai Hospital, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00576212     History of Changes
Other Study ID Numbers: 07-0157-E
Study First Received: December 17, 2007
Last Updated: July 29, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
termination fetal anomaly
psychological sequelae pregnancy termination for anomalies
supportive follow-up pregnancy termination anomalies

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 18, 2013