Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT06986616
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fibroids and the Risk of Miscarriage: a Prospective Observational Study in an Early Pregnancy Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 436}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Uterine volume and value as a surrogate marker for fibroid mapping', 'timeFrame': 'From enrollment to end of data collection (from 24 weeks onwards).', 'description': 'Can uterine volume be used as a surrogate marker for fibroid mapping - and does this have an association with miscarriage'}], 'primaryOutcomes': [{'measure': 'Miscarriage prior to 24 weeks', 'timeFrame': 'From enrollment to the end of data collection (data would be collected from 24 weeks)', 'description': 'Miscarriage prior to 24 weeks - or delivery prior to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Risk of miscarriage based on fibroid characteristics', 'timeFrame': 'From enrollment until data colelction (from 24 weeks)', 'description': 'Risk of miscarriage based on volume, size and location of fibroids'}, {'measure': 'Risk of miscarriage according to trimester', 'timeFrame': 'From enrollment to end of data collection (from 24 weeks)', 'description': 'Risk of miscarriage according to trimester'}, {'measure': 'Presence of symptoms of pain or bleeding and association with fibroids and trimester', 'timeFrame': 'From enrollment to end of data collection (from 24 weeks)', 'description': 'Presence of symptoms of pain or bleeding and association with fibroids and trimester'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fibroid', 'miscarriage'], 'conditions': ['Fibroid', 'Miscarriage in First Trimester', 'Miscarriage in Second Trimester']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to whether fibroids increase the risk of miscarriage in women in our early pregnancy population.\n\nWe will be collecting lots of data detailing other factors, which may have an impact on overall health and on the risk of miscarriage (this includes age, weight, use of vitamins or progesterone supplements, postcode which is linked to national deprivation scoring status and employment status).\n\nBy collecting all this data, we hope to remove the effect of other factors and purely assess the effect that the fibroids have on the outcome in early pregnancy.\n\nWe will also be looking closely at whether the location, number or size of the fibroids can affect the pregnancy too and following up women at 24 weeks via phone. We will also look at other secondary outcomes such whether women with fibroids experience symptoms of pain or bleeding in the first or second trimester more so than their control counterparts. We will also look at the value of uterine volume as a surrogate marker of fibroid mapping.\n\nOnce all the data has been analysed, we will be able to assess whether fibroids lead to an increased risk of miscarriage. We hope that this information will be useful in counselling women affected by fibroids in the pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women attending the early pregnancy unit in our London hospital will be the target population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women presenting at less than 10 weeks gestation either by last menstrual period or by transvaginal scan findings with an early intrauterine or ongoing pregnancy on scan\n\nExclusion Criteria:\n\n* Women declining participation and follow up\n* Women wishing to pursue termination of pregnancy\n* Women who refuse transvaginal scan\n* Multiple pregnancy\n* Ectopic pregnancy\n* Pregnancy of unknown location\n* Embryonic demise\n* Under 16\n* Unable to understand - interpreting services will be used such as language line if required.'}, 'identificationModule': {'nctId': 'NCT06986616', 'acronym': 'FiRM', 'briefTitle': 'Fibroids and the Risk of Miscarriage: a Prospective Observational Study in an Early Pregnancy Population', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'Fibroids and the Risk of Miscarriage', 'orgStudyIdInfo': {'id': 'KCH19-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases - fibroids', 'description': 'Women with fibroids'}, {'label': 'Controls - no fibroids', 'description': 'Women without fibroids'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': "Early Pregnancy and Gynaecology Assessment Unit, King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data is available for reasonable requests including study protocol and anonymised data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}