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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)

S

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Withdrawn

Conditions

Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly

Treatments

Behavioral: supportive call

Study type

Interventional

Funder types

Other

Identifiers

NCT00576212
07-0157-E

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

A
Experimental group
Description:
Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months.
Treatment:
Behavioral: supportive call
B
No Intervention group
Description:
Subjects in the control group will receive no intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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