Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-27 @ 8:16 AM
Study NCT ID:
NCT05957666
Status:
UNKNOWN
Last Update Posted:
2023-07-24
First Post:
2023-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'patients will either recieve oral or vaginal misoprostol by envelope method ina dose of 50microgram.Total of 176 envelopes are placed in a concealed box.Neither the doctor nor the patient knows.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Total 176 patient included in this study.Patients will be randomised by envelop method to recieve either oral or vaginal misoprostol in a dose of 50microgram.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-15', 'studyFirstSubmitDate': '2023-07-15', 'studyFirstSubmitQcDate': '2023-07-15', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vaginal birth', 'timeFrame': 'vaginal birth within 24 hours of admission', 'description': 'vaginal birth within 24 hours of admission with 2 doses of misoprostol given 6 hours apart'}], 'secondaryOutcomes': [{'measure': 'cesaerean section', 'timeFrame': 'within 24 hours', 'description': 'cesaerean section if patient doesnt go in labour despite 2 doses or fetal distress occurs'}, {'measure': 'induction to delivery interval', 'timeFrame': 'within 24 hours', 'description': 'measured from 1st dose till delivery of patient'}, {'measure': 'fetal distress', 'timeFrame': 'within 24 hours', 'description': 'fetal distress measured by non reactive CTG or meconium stained amniotic fluid'}, {'measure': 'uterine hyperstimulation', 'timeFrame': 'more than 10 cotractions in every 10 minutes', 'description': 'more than 5 contractions in every 10 minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['induction of labour', 'misoprostol'], 'conditions': ['Induction of Labour With Misoprostol']}, 'descriptionModule': {'briefSummary': 'A randomised control trial to compare oral and vaginal misoprostol for induction of labour in term patients.The objective is to determine whether use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of lessthan or equal to 6 who require induction of labpour at term compared to oral misoprostol regimen.', 'detailedDescription': 'The objective of study is to determine whether the use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of less than or equal to 6 who require induction of labour at term compared to oral misoprostol regimen.It is a randomised control trial conducted in department of obs and gynae unit 1 from june 2023.\n\nTotal 176 patients are included in this study and they will be randomised by envelope method to recieve either oral or vaginal misoprostol in a dose of 50microgram.In both groupds dose will be repeated after 6 hours if required.Maximum 2 doses will be given.patients will be monitored for uterine contractions and fetal hearts.Vaginal examination will be done at 4hours and 8 hours following misoprostol dose or earlier if patient complains of leaking and labour pains.Membranes will be ruptured once cervical dilatation is greater than 3cm.in absence of adequate uterine contractions oxytocin infusion will be started.Fetal hearts will be monitored every 30 minutes from time of induction.Progress of labour will be assessed through partogram.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCephalic presentation Prelabour rupture of membranes Singleton pregnancies reaching 41 weeks G1 to G4 Bishop score of less than or equal to 6 Medical disorders(GDM,PIH) -\n\nExclusion Criteria:\n\nPrevious uterine scar Antepartum hemorrhage Cephalopelvic disproportion Multiple gestation Multiparity Oligohydramnios/polyhydramnios IUGR Severe systemic illness like pre eclampsia,eclampsia,cardiac,hepatic,renal disease PPROM\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05957666', 'briefTitle': 'Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Services Institute of Medical Sciences, Pakistan'}, 'officialTitle': 'Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term', 'orgStudyIdInfo': {'id': 'IRB/2023/1129/SIMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oral misoprostol', 'description': 'oral misoprostol will be given in a dose of 50microgram and repeated after 6 hours if required.Maximum 2 doses will be given', 'interventionNames': ['Drug: Misoprostol Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vaginal misoprostol', 'description': 'vaginal misoprostol will be given in a dose of 50 microgram and repeated after 6 hours if required.Maximum 2 doses will be given', 'interventionNames': ['Drug: vaginal misoprostol']}], 'interventions': [{'name': 'Misoprostol Oral Tablet', 'type': 'DRUG', 'otherNames': ['cytotec'], 'description': 'oral misoprostol 50 microgram repeated after 6 hours if required', 'armGroupLabels': ['oral misoprostol']}, {'name': 'vaginal misoprostol', 'type': 'DRUG', 'otherNames': ['cytotec'], 'description': 'vaginal misoprostol 50 microgram repeated after 6 hours if required', 'armGroupLabels': ['vaginal misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Tayyiba Wasim, FCPS', 'role': 'CONTACT', 'email': 'tayyibawasim@yahoo.com', 'phone': '03008400197', 'phoneExt': '92'}, {'name': 'Kalsoom Waheed, FCPS', 'role': 'CONTACT', 'email': 'zainabmohsin09@gmail.com', 'phone': '03214262687', 'phoneExt': '92'}], 'facility': 'Services Institute Of Medical Sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Tayyiba Wasim, FCPS', 'role': 'CONTACT', 'email': 'tayyibawasim@yahoo.com', 'phone': '03008400197', 'phoneExt': '92'}, {'name': 'Kalsoom Waheed, FCPS', 'role': 'CONTACT', 'email': 'zainabmohsin09@gmail.com', 'phone': '03214262687', 'phoneExt': '92'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Services Institute of Medical Sciences, Pakistan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Obstetrics and Gynaecology', 'investigatorFullName': 'Tayyiba Wasim', 'investigatorAffiliation': 'Services Institute of Medical Sciences, Pakistan'}}}}