- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00576212
Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly (TOPFA)
July 29, 2009 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eileen Sloan, PhD MD FRCP, Mount Sinai Hospital, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Study Completion (Anticipated)
September 1, 2009
Study Registration Dates
First Submitted
December 17, 2007
First Submitted That Met QC Criteria
December 17, 2007
First Posted (Estimate)
December 19, 2007
Study Record Updates
Last Update Posted (Estimate)
July 30, 2009
Last Update Submitted That Met QC Criteria
July 29, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-0157-E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly
-
China Medical University HospitalUnknownTermination of Pregnancy
-
Centre Hospitalier Universitaire DijonRecruitingMedical Termination of Pregnancy | Voluntary Termination of PregnancyFrance
-
Sohag UniversityNot yet recruiting
-
Hospices Civils de LyonCompletedMedical Termination of PregnancyFrance
-
Gynuity Health ProjectsCompletedTermination of PregnancyUnited States
-
Gynuity Health ProjectsCompletedTermination of PregnancyUnited States, Moldova, Republic of, Nepal
-
University Hospital, MontpellierCompletedTermination of PregnancyFrance
-
Oshri BarellUnknownInduced Abortion and Complications of Termination of PregnancyIsrael
-
Assistance Publique - Hôpitaux de ParisINSERM U1153CompletedTermination of Pregnancy (TOP)France
-
University Hospital, BrestUnknownMedical Termination of PregnancyFrance
Clinical Trials on supportive call
-
PfizerCompletedMetastatic/Advanced Renal Cell CarcinomaFrance
-
University of Massachusetts, WorcesterNational Cancer Institute (NCI); Reliant Medical Group; Fallon Community Health...Completed
-
NYU Langone HealthCompleted
-
Vienna Institute for Research in Ocular SurgeryRecruiting
-
Baoshan Prefecture Center for Disease Control and...Prince of Songkla UniversityUnknownMedication AdherenceChina
-
Swansea UniversityAbertawe Bro Morgannwg University Health BoardRecruitingPelvic Floor DysfunctionsUnited Kingdom
-
Montefiore Medical CenterCompletedPatient ComplianceUnited States
-
University of PittsburghUniversity of Pittsburgh Medical CenterCompletedPelvic Organ Prolapse | Patient PreparednessUnited States
-
University of CopenhagenRecruitingWisdom TeethDenmark
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingMild Traumatic Brain InjuryFrance