Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-02-26 @ 4:13 PM
Study NCT ID:
NCT03175406
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2017-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting the Outcomes of Labor Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2017-05-28', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the occurrence of active labor', 'timeFrame': 'within one day of labor induction', 'description': 'successful labor induction(IOL)'}], 'secondaryOutcomes': [{'measure': 'The interval from onset of induction to active labor', 'timeFrame': '24 hours', 'description': 'duration of induction'}, {'measure': 'Successful vaginal delivery', 'timeFrame': '48 hours'}, {'measure': 'The need for cesarean delivery (CS)', 'timeFrame': '24 hours', 'description': 'indication of CS (fetal distress ,failed induction,...)'}, {'measure': 'maternal and fetal complication associated with IOL', 'timeFrame': 'during induction ,labor, and 24 hours postpartum', 'description': 'tachy systole, postpartum hemorrhage, fetal distress'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Induction of Labor Affected Fetus / Newborn']}, 'descriptionModule': {'briefSummary': 'Pre induction assessment using bishop scoring system and Manipal cervical scoring system performed on 105 pregnant females', 'detailedDescription': 'preinduction cervical assessment using The Burnett modification of Bishop score with\n\n1. Cervical dilatation in centimeters will be given a score of zero if dilatation less than 1cm, a score of 1 if 1-2 cm dilated, a score of 2 if more than 2 cm dilataion.\n2. Length of the cervix will be given a score of zero if more than 2 cm, a score of 1 if 1-2 cm, a score of 2 if less than 1 cm.\n3. Station of fetal head will be given a score of zero if -2 or higher , a score of 1 if -1, a score of 2 if zero or lower.\n4. Consistency of the cervix will be given a score of zero if firm, a score of 1 if soft and a score of 2 if soft and stretchable.\n5. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated.\n\nand also preinduction cervical assessment using transvaginal ultrasound and Manipal system where:\n\n1. Length of the cervix will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm.\n2. Length of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.\n3. width of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.\n4. cervical position and shape will be given a score of zero if curved, a score of 2 if straight\n5. Distance of presenting part to external os will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '105 females with singleton term pregnancy undergoing induction of labor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Singleton gestation at 37 completed weeks or greater .\n2. Cephalic presentation.\n3. Longitudinal lie.\n4. Living fetus.\n5. Intact membrane\n\nExclusion Criteria:\n\n1. Previous cesarean delivery or rupture uterus.\n2. Antepartum hemorrhage including (abruptio placenta, placenta previa or vasa previa).\n3. Abnormal fetal lie or presentation.\n4. Pervious uterine surgery as myomectomy.\n5. Category II, III non stress test.\n6. Pelvic structural deformity.\n7. Intrautrine growth retardation or macrosomia (estimated fetal weight ˃ than 4kg).\n8. Patients who received any pre induction ripening.\n9. Active genital herpes.\n10. Invasive cervical carcinoma'}, 'identificationModule': {'nctId': 'NCT03175406', 'briefTitle': 'Predicting the Outcomes of Labor Induction', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparing the Accuracy of Manipal Cervical Scoring System and Modified Bishop Score in Predicting Successful Induction of Labor', 'orgStudyIdInfo': {'id': 'ASU maternity hospital'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Manipal cervical scoring system', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['The Burnett modification of Bishop score']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gasser M El-Bishry, MD,FRCOG', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor'}, {'name': 'Ihab F Allam, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of obstetrics and gynecology', 'investigatorFullName': 'Radwa Rasheedy Ali', 'investigatorAffiliation': 'Ain Shams University'}}}}