Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02989220
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2016-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of a Coping Intervention for Recurrent Miscarriage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable', 'timeFrame': 'Through Study Completion - Average of 1 year', 'description': 'How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?'}, {'measure': 'Number of patients recruited into the study using current inclusion/exclusion criteria', 'timeFrame': 'Through Study Completion - Average of 1 year', 'description': 'Is it possible to achieve acceptable recruitment and retention rates within each centre, taking into account defined inclusion/exclusion criteria?'}, {'measure': 'Number of completed questionnaires', 'timeFrame': 'Through Study Completion - Average of 1 year', 'description': 'Are the proposed study questionnaires and data collection methods appropriate?'}, {'measure': 'Data collected from questionnaires', 'timeFrame': 'Through Study Completion - Average of 1 year', 'description': 'Is there a preliminary indication of an effect of the PRCI?'}], 'secondaryOutcomes': [{'measure': 'Data Collected from questionnaires', 'timeFrame': 'Through Study Completion - Average of 1 year', 'description': "Qualitative analysis of questionnaires to explore in-depth women's subjective experience of the study intervention and research methods (including study outcome measures)."}, {'measure': 'Data Collected from questionnaires', 'timeFrame': 'Through Study Completion - Average of 1 year', 'description': 'Qualitative analysis of questionnaires to provide information to refine the study intervention (if required).'}, {'measure': 'Data Collected from questionnaires', 'timeFrame': 'Through Study Completion - Average of 1 year', 'description': 'Qualitative analysis of questionnaires to strengthen further in-depth understanding of the initial experience of pregnancy following repeated miscarriages.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Miscarriage'], 'conditions': ['Miscarriage']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with three or more miscarriages\n* Women aged \\>18 years\n* Willing and able to give written consent\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT02989220', 'briefTitle': 'Feasibility Study of a Coping Intervention for Recurrent Miscarriage', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': 'A Feasibility and Acceptability Study and a Qualitative Process Evaluation of a Coping Intervention for Women With Recurrent Miscarriage', 'orgStudyIdInfo': {'id': 'RHM O&G0207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Will receive the PRCI in addition to the current recommended care pathway', 'interventionNames': ['Other: Positive Reappraisal Coping Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Will follow the current recommended care pathway'}], 'interventions': [{'name': 'Positive Reappraisal Coping Intervention', 'type': 'OTHER', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO16 8YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Princess Anne Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}