Psychological Sequelae of Termination of Pregnancy for Fetal AnomalyTOPFANCT00576212
Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly
A study testing supportive call in people with Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly
- What is being tested?
- supportive call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -women who are currently seeing a therapist or undergoing psychiatric care, and women who do not meet all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- supportive call
- Keywords
- termination fetal anomaly, psychological sequelae pregnancy termination for anomalies, supportive follow-up pregnancy termination anomalies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supportive callBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months. Receives: Behavioral: supportive call |
| B | No intervention | Subjects in the control group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (1)
Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startSep 2007
- Study completionSep 2009 (estimated)
Why it stopped: Study halted prematurely, prior to enrollment of first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Sequelae of Termination of Pregnancy for Fetal AnomalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Eileen Sloan, PhD MD FRCP, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576212
- Sponsor's protocol ID
- 07-0157-E
- Acronym
- TOPFA
- Status last verified
- Jul 2009
- First submitted
- 17 Dec 2007
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00576212
- Acronym / sponsor ID
- TOPFA / 07-0157-E
- Keywords
- termination fetal anomaly, psychological sequelae pregnancy termination for anomalies, supportive follow-up pregnancy termination anomalies
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: supportive callSubjects in the intervention group will receive supportive telephone calls biweekly for 6 months. |
| B | No intervention | –Subjects in the control group will receive no intervention. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -women who are currently seeing a therapist or undergoing psychiatric care, and women who do not meet all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supportive callEach 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. | Behavioural | A |
Primary outcome
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
1 secondary outcome
Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen Sloan, PhD MD FRCP principal investigator
Mount Sinai Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supportive call in people with Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2009.