Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-29 @ 11:48 PM
Study NCT ID:
NCT05559957
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2022-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016104', 'term': 'Oligohydramnios'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 636}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delivery mode', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Either vaginal delivery or cesarean section'}, {'measure': 'Composite neonatal outcomes', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Risk of low Apgar score, transient tachypnea of newborn, ICU admission, etc'}], 'secondaryOutcomes': [{'measure': 'Induction of labor rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Comparing incidence of labor induction between both groups and between gestational age groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oligohydramnios, Delivered']}, 'referencesModule': {'references': [{'pmid': '14961882', 'type': 'BACKGROUND', 'citation': 'Zhang J, Troendle J, Meikle S, Klebanoff MA, Rayburn WF. Isolated oligohydramnios is not associated with adverse perinatal outcomes. BJOG. 2004 Mar;111(3):220-5. doi: 10.1111/j.1471-0528.2004.00060.x.'}]}, 'descriptionModule': {'briefSummary': 'Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome.', 'detailedDescription': 'Retrospective study conducted in Armed Forces Hospitals of Southern Region, comparing cases with oligohydramnios (amniotic fluid level index \\<5) to normal amniotic fluid cases (amniotic fluid level index ≥ 8). Primary outcomes are the mode of delivery and adverse perinatal outcomes (including mortality, NICU admission, low Apgar score and sepsis)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women between 32 and 41 weeks with otherwise normal pregnancy. Isolated oligohydramnios group are diagnosed with amniotic fluid index less than 5.', 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Third trimester pregnancy\n2. Isolated oligohydramnios\n\nExclusion Criteria:\n\n1. Multiple pregnancy\n2. less than 32 weeks\n3. medical disorders like DM HPN\n4. Fetal jeopardy'}, 'identificationModule': {'nctId': 'NCT05559957', 'briefTitle': 'Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Isolated Oligohydramnios is Associated With Less Favorable Delivery and Composite Neonatal Outcomes', 'orgStudyIdInfo': {'id': 'AFHSRMREC/2020/OB/GYNAE/429'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isolated oligohydramnios group', 'description': 'Cases with oligohydramnios (amniotic fluid index less than 5) without an overt underlying reason in the third trimester', 'interventionNames': ['Behavioral: observation of delivery and neonatal outcomes']}, {'label': 'Normal amniotic fluid group', 'description': 'Normal pregnancy cases with normal amniotic fluid index', 'interventionNames': ['Behavioral: observation of delivery and neonatal outcomes']}], 'interventions': [{'name': 'observation of delivery and neonatal outcomes', 'type': 'BEHAVIORAL', 'description': 'MONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS', 'armGroupLabels': ['Isolated oligohydramnios group', 'Normal amniotic fluid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62411', 'city': 'Khamis Mushait', 'country': 'Saudi Arabia', 'facility': 'Armed Forces Hospitals Southern Region', 'geoPoint': {'lat': 18.3, 'lon': 42.73333}}], 'overallOfficials': [{'name': 'Hytham Atia Atia, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armed Forces Hospitals Southern Region KSA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hytham Atia', 'investigatorAffiliation': 'Zagazig University'}}}}