Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-18 @ 9:43 PM
Study NCT ID:
NCT02686112
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2016-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy Outcome in Woman With Threatened Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000033', 'term': 'Abortion, Threatened'}], 'ancestors': [{'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': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-15', 'studyFirstSubmitDate': '2016-01-28', 'studyFirstSubmitQcDate': '2016-02-15', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal and neonatal outcome in pregnancies with 1st and 2nd trimester bleeding', 'timeFrame': '9 months', 'description': 'by using our data in the past 7 years we will examine retrospectively cases of patients from their first admission due to vaginal bleeding throgh their pregnancy and labor .\n\nthe mesearment will include : Intra uterine growth retardation , Antepartum hemorrhage, premature rupture of membrane, Intra uterine fetal death , Preterm delivery, Apgar less than 7, Congenital malformation, Mode of delivery - vaginal delivery vs. cesarean section'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Threatened Abortion']}, 'descriptionModule': {'briefSummary': 'The study aims to quantify the relations between first \\& second trimester bleeding and maternal \\& neonatal morbidity. Additionally, the study will help in assessing the risk for abortions in women with threatened abortions and the risk factors for threatened abortion.', 'detailedDescription': 'the study is following woman retrospectively through their pregnancy from the first trimester troughout delivery .\n\nwe will measure the relation between first and/or second trimester bleeding ( threatend abortion ) and pregnancy outcome ( as written below ) - maternal and neonatal .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women who attanded the Emergency department with vaginal bleeding and/or abdominal pain and were on their 20th week of pregnancy or less.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who attended the Emergency department with vaginal bleeding and/or abdominal pain and were on their 20th week of pregnancy or less.\n\nExclusion Criteria:\n\n* Women with any background that can explain vaginal bleeding or any other circumstance that can explain it.'}, 'identificationModule': {'nctId': 'NCT02686112', 'acronym': 'POTA', 'briefTitle': 'Pregnancy Outcome in Woman With Threatened Abortion', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'Pregnancy Outcome in Woman With Threatened Abortion', 'orgStudyIdInfo': {'id': 'BNZ-0043-14'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eyal Levy, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bnai Zion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Eyal.levy', 'investigatorAffiliation': 'Bnai Zion Medical Center'}}}}