Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 4:16 PM
Study NCT ID:
NCT04415359
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2020-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Evolution of Pregnancies in the First Trimester Following MAR Management During a COVD-19 Pandemic Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study of the evolution of pregnancies in the first trimester following MAR management during a COVD-19 pandemic period', 'timeFrame': '12th week of Amenorrhea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2', 'ARDS', 'ICU', 'Pregnant women', 'Pregnancy', 'Fetus', 'Middle East Respiratory Syndrome', 'MERS', 'Maternal respiratory impairment', 'Medical Assisted Procreation', 'MAR', 'Frozen embryos'], 'conditions': ['Covid-19']}, 'descriptionModule': {'briefSummary': 'Because of the physiological changes inherent in pregnancy, pregnant women with lower respiratory tract infections often have more worrisome outcomes compared to non-pregnant individuals, including a higher rate of hospital and intensive care unit admissions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient included in MAR protocol aged between 18 and 43 years of age who has already signed a consent to management', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient included in a Medically Assisted Procreation (MAR) protocol aged between 18 and 43 years of age\n* Patient who has already signed a consent to management\n\nExclusion Criteria:\n\n* Patient who expressed opposition to participating in the study'}, 'identificationModule': {'nctId': 'NCT04415359', 'acronym': 'AMPCOVID-19', 'briefTitle': 'Evaluation of the Evolution of Pregnancies in the First Trimester Following MAR Management During a COVD-19 Pandemic Period', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evaluation of the Evolution of Pregnancies in the First Trimester Following a Medically Assisted Procreation (MAR) Management During a COVD-19 Pandemic Period', 'orgStudyIdInfo': {'id': '7789'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': "Service Clinico biologique d'Assistance Médicale à La Procréation", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}