Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04910958
Status:
COMPLETED
Last Update Posted:
2022-12-06
First Post:
2021-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 411}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2021-06-01', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of early missed abortions', 'timeFrame': 'Two years', 'description': 'Number of early missed abortions in the first trimester in COVID19 time compared to years prior'}, {'measure': 'Number of termination of pregnancies', 'timeFrame': 'Two years', 'description': 'Number of termination of pregnancies in the first trimester in COVID19 time compared to years prior'}], 'secondaryOutcomes': [{'measure': 'Time between discovery and attendance', 'timeFrame': '1 year', 'description': 'Time between discovery and attendance in missed abortions during COVID19 time compared to years prior'}, {'measure': 'Comparison of reasons for termination', 'timeFrame': '1 year', 'description': 'Comparison of reasons for termination of pregnancy during COVID19 time compared to years prior'}, {'measure': 'Comparison of Age/Religion/Demographic variables', 'timeFrame': '1 year', 'description': 'Comparison of Age/Religion/Demographic variables of termination of pregnancy during COVID19 time compared to years prior'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Termination of Pregnancy', 'Covid19', 'Pregnancy Loss']}, 'descriptionModule': {'briefSummary': 'To see the impact the COVID-19 pandemic has had on early spontaneous abortions and early termination of pregnancy in the first trimester', 'detailedDescription': 'To date, the research has focused on the complications of SARS-CoV-2 in pregnant women. There is no research in the literature that has compared the rates and behavior of miscarriage during the time of the COVID-19 pandemic to before the time of the pandemic. As described in the literature, there is an established connection between COVID-19 and stress, anxiety, and depression. There is also an established connection between stress, anxiety, and depression and rates of miscarriage. The investigators hereby wish to analyze the effect of the COVID-19 pandemic on miscarriages.\n\nIn this study, The investigators will analyze the number of early missed abortions and number of termination of pregnancies in the first trimester before and during the COVID-19 pandemic. The investigators will also analyze the time interval between diagnosis of missed abortion and attendance to E.R in missed abortions during the COVID-19 pandemic. In addition, The investigators will be comparing the reasons for termination of pregnancy during this time, as well as analyzing age, religion, and demographic variables during the COVID-19 pandemic compared to years prior.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women attending for early missed abortion or termination of pregnancy receiving treatment between March 11th - November 30th during the years 2017-2020 Gestational age until 12 weeks 6 days (1st trimester only)', 'genderDescription': 'Females only', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women attending for early missed abortion or termination of pregnancy receiving treatment between March 11th - November 30th during the years 2017-2020 Gestational age until 12 weeks 6 days (1st trimester only)\n\nExclusion Criteria:\n\n* Incomplete and complete abortions\n* Gestational age \\>13 weeks'}, 'identificationModule': {'nctId': 'NCT04910958', 'briefTitle': 'Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy', 'orgStudyIdInfo': {'id': '0199-20-HYMC'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Omer Mor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'omer.moore@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}