Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT03682718
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2018-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-16', 'studyFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neonatal Apgar score', 'timeFrame': '1 min after delivery', 'description': 'Neonatal Apgar score'}, {'measure': 'Neonatal Apgar score', 'timeFrame': '5 min after delivery', 'description': 'Neonatal Apgar score'}, {'measure': 'Neonatal birth weight', 'timeFrame': '10 min after delivery', 'description': 'Neonatal birth weight'}, {'measure': 'neonatal ICU admission', 'timeFrame': '2 hours after delivery', 'description': 'Number of neonates in need for ICU admission'}], 'primaryOutcomes': [{'measure': 'induction delivery time', 'timeFrame': '48 hours', 'description': 'time elapsed from start of induction till delivery of the baby'}], 'secondaryOutcomes': [{'measure': 'misoprstol dose', 'timeFrame': '24 hours', 'description': 'total misoprstol needed in each group'}, {'measure': 'induction active stage time', 'timeFrame': '24 hours', 'description': 'time elapsed from induction of labor till reaching 6 cm cervical dialtation'}, {'measure': 'Mode of delivery', 'timeFrame': '48 hours', 'description': 'mode od delivery either vaginal or Caesarian Section'}, {'measure': 'Maternal Pyrexia', 'timeFrame': '48 hours', 'description': 'fever (Temp \\> 37.8 ) any time during labor'}, {'measure': 'hypersystole', 'timeFrame': '48 hours', 'description': 'one uterine contraction with duration of more than 90 sec.'}, {'measure': 'Tachysystole', 'timeFrame': '48 hours', 'description': 'Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['misoprostol , intracervical Foley catheter , induction of labor , term pregnancy.'], 'conditions': ['Induction of Labor Affected Fetus / Newborn']}, 'referencesModule': {'references': [{'pmid': '36996264', 'type': 'DERIVED', 'citation': 'de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.', 'detailedDescription': 'Cervical status is a good predictor of the likelihood of vaginal delivery when labor is induced. Any induction method is likely to be effective in a woman with a favorable cervix, whereas no method is highly successful when performed in a woman with a cervix that is unfavorable.\n\nThe use of a balloon catheter as induction method was first described in 1862 by Trainer. The goal of the catheter was to ripen the cervix through direct mechanical dilatation of the cervical canal and indirectly by increasing endogenous prostaglandin secretion.\n\nAlternatively, Prostaglandins are one of the key players in cervical ripening by a number of different mechanisms.\n\nThe aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSingleton pregnancy Gestational age ≥ 37 weeks (calculated from reliable menstrual dates and/or late first trimester or early second trimester ultrasound) Modified Bishop Score ≥ 5 Valid indication for induction of labor Intact fetal membranes Normal fetal non-stress test cervical dilation less than or equal to 2cm vertex presentation\n\nExclusion Criteria:\n\nAny contraindication for vaginal delivery (e.g. placenta Previa, accrete ) Any contraindication for induction of labor (e.g. fetal malpersentation, prior uterine surgery) Active labor Antepartum hemorrhage Eclampsia Patients with hemolysis, elevated liver enzymes and low platelets Suspected chorioamnitis Intrauterine growth retardation Multiple gestation Non-reassuring fetal heart rate Continuous contractions more than 3 times in 10 minutes at onset of induction of labor Intrauterine fetal demise Any contraindication for use of misoprostol (e.g. bronchial asthma, drug allergy, History of glaucoma) Any contraindication for use of Foley catheter (already ripped cervix) Rupture of membranes Not consenting'}, 'identificationModule': {'nctId': 'NCT03682718', 'briefTitle': 'Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Vaginal Misoprostol With Intracervical Foley Catheter Versus Vaginal Misoprostol Alone in Induction of Labor at Term Pregnancy', 'orgStudyIdInfo': {'id': 'ase36278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vaginal misoprostol and intracervical Foley catheter', 'description': 'participants will receive misoprostol by the same dose and method. Transcervical Foley catheter (size 16F, with 30ml balloon capacity) will be passed. The catheter will deflated, removed and cervix re-assessed if no spontaneous expulsion occurred at 12 hours post- insertion. A new catheter will be passed for another 12 hours, if the Bishop score is less than 8 this will be considered as failure of induction.', 'interventionNames': ['Device: Transcervical Foley catheter', 'Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vaginal misoprostol', 'description': 'Misoprostol group; participants will receive 50 μg intravaginal in the posterior vaginal fornix, 25 μg will be given every 4 hours for another two doses, if a satisfactory Bishop score of 8 not reached, patient will take an overnight rest and she will continue induction by the same doses on the next day-provided that there is no ROMs- (this is according to Ain Shams University Protocol) The maximum dose of Misoprostol is 200 μg.\n\nOxytocin infusion will not started until 6 hours after the last dose or if there is no adequate contractions obtained.', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Transcervical Foley catheter', 'type': 'DEVICE', 'description': 'combined methods of induction of labor Floey Catheter with misoprstol', 'armGroupLabels': ['vaginal misoprostol and intracervical Foley catheter']}, {'name': 'Misoprostol', 'type': 'DRUG', 'description': 'Misoprstol inserted vaginally for induction of labor', 'armGroupLabels': ['vaginal misoprostol', 'vaginal misoprostol and intracervical Foley catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ahmed Abass', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ahmed Abass', 'investigatorAffiliation': 'Ain Shams University'}}}}