MiscarriageNCT02989220
Feasibility Study of a Coping Intervention for Recurrent Miscarriage
A study testing Positive Reappraisal Coping Intervention in people with Miscarriage, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Some women experience the pain of miscarriage on numerous occasions. Studies show that these women experience feelings of anxiety and distress during the early stages of a new pregnancy as they worry another miscarriage will occur. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Miscarriage
- What is being tested?
- Positive Reappraisal Coping Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2014to 31 May 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with three or more miscarriages
- Women aged >18 years
- Willing and able to give written consent
Who cannot join
- Women will be excluded from this study if they do not speak English well enough to understand and complete study materials. This criterion is in place because the study materials (including PRCI) are not currently available in translation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility and Acceptability Study and a Qualitative Process Evaluation of a Coping Intervention for Women With Recurrent Miscarriage
Some women experience the pain of miscarriage on numerous occasions. Studies show that these women experience feelings of anxiety and distress during the early stages of a new pregnancy as they worry another miscarriage will occur. This study will investigate whether a coping strategy, developed for a similar group of women, would be acceptable and useful to women suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A secondary aim of the study is to develop a deeper understanding of the experiences and feelings of women in the early stages of a new pregnancy, following multiple miscarriages.
- Conditions
- Miscarriage
- Being tested
- Positive Reappraisal Coping Intervention
- Keywords
- Miscarriage
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Reappraisal Coping InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Will receive the PRCI in addition to the current recommended care pathway Receives: Other: Positive Reappraisal Coping Intervention |
| Control Group | No intervention | Will follow the current recommended care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable
How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?
Measured: Through Study Completion - Average of 1 year
Number of patients recruited into the study using current inclusion/exclusion criteria
Is it possible to achieve acceptable recruitment and retention rates within each centre, taking into account defined inclusion/exclusion criteria?
Measured: Through Study Completion - Average of 1 year
Number of completed questionnaires
Are the proposed study questionnaires and data collection methods appropriate?
Measured: Through Study Completion - Average of 1 year
Data collected from questionnaires
Is there a preliminary indication of an effect of the PRCI?
Measured: Through Study Completion - Average of 1 year
Secondary outcomes (3)
Data Collected from questionnaires
Qualitative analysis of questionnaires to explore in-depth women's subjective experience of the study intervention and research methods (including study outcome measures).
Measured: Through Study Completion - Average of 1 year
Data Collected from questionnaires
Qualitative analysis of questionnaires to provide information to refine the study intervention (if required).
Measured: Through Study Completion - Average of 1 year
Data Collected from questionnaires
Qualitative analysis of questionnaires to strengthen further in-depth understanding of the initial experience of pregnancy following repeated miscarriages.
Measured: Through Study Completion - Average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start17 Jan 2014
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989220
- Sponsor's protocol ID
- RHM O&G0207
- Status last verified
- Sep 2018
- First submitted
- 14 Oct 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Acceptability Study and a Qualitative Process Evaluation of a Coping Intervention for Women With Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT02989220
- Acronym / sponsor ID
- RHM O&G0207
- Conditions
- Miscarriage
- Keywords
- Miscarriage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 17 Jan 2014 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 12 Dec 2016 (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.
Some women experience the pain of miscarriage on numerous occasions. Studies show that these women experience feelings of anxiety and distress during the early stages of a new pregnancy as they worry another miscarriage will occur. This study will investigate whether a coping strategy, developed for a similar group of women, would be acceptable and useful to women suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A secondary aim of the study is to develop a deeper understanding of the experiences and feelings of women in the early stages of a new pregnancy, following multiple miscarriages.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Positive Reappraisal Coping InterventionWill receive the PRCI in addition to the current recommended care pathway |
| Control Group | No intervention | –Will follow the current recommended care pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with three or more miscarriages
- Women aged >18 years
- Willing and able to give written consent
Key exclusion criteria (1 listed)
- Women will be excluded from this study if they do not speak English well enough to understand and complete study materials. This criterion is in place because the study materials (including PRCI) are not currently available in translation.
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 |
|---|---|---|
| Positive Reappraisal Coping Intervention | Other | Intervention group |
Primary outcome
Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable
Time frame: Through Study Completion - Average of 1 year
How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?
Number of patients recruited into the study using current inclusion/exclusion criteria
Time frame: Through Study Completion - Average of 1 year
Is it possible to achieve acceptable recruitment and retention rates within each centre, taking into account defined inclusion/exclusion criteria?
Number of completed questionnaires
Time frame: Through Study Completion - Average of 1 year
Are the proposed study questionnaires and data collection methods appropriate?
Data collected from questionnaires
Time frame: Through Study Completion - Average of 1 year
Is there a preliminary indication of an effect of the PRCI?
3 secondary outcomes
Data Collected from questionnaires
Time frame: Through Study Completion - Average of 1 year
Data Collected from questionnaires
Time frame: Through Study Completion - Average of 1 year
Data Collected from questionnaires
Time frame: Through Study Completion - Average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Reappraisal Coping Intervention in people with Miscarriage, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 7 Sep 2018. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable (time frame: Through Study Completion - Average of 1 year). The study lists 4 primary outcomes in all. 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 7 Sep 2018.