Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT03544606
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2018-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C030397', 'term': 'isosorbide-5-mononitrate'}, {'id': 'D011736', 'term': 'Pyridoxine'}], 'ancestors': [{'id': 'D025101', 'term': 'Vitamin B 6'}, {'id': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'To insure that everyone has the chance of participation, Randomization will be done using computer generated randomization sheet using statsdirect version 3. Double blinding will be done by one of the supervisors who will be the only one to know the key, thus the care provider and the patient will not know is it the drug or the placebo.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be divided into 2 groups.\n\nGroup 1:\n\n80 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM)\n\nGroup 2:\n\n80 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'admission-delivery interval', 'timeFrame': 'up to 24 hours', 'description': 'The time from initiation labor induction and delivery of placenta'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Induction of Labor Affected Fetus / Newborn']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor.\n\nResearch Hypothesis:\n\nIn women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.\n\nResearch Questions:\n\nDoes vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor?', 'detailedDescription': '* Type of Study : Prospective double blind randomized controlled clinical trial.\n* Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital.\n* Study Period : Expected 6 months from December 2023 to June 2024.\n* Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy.\n* Cephalic presentation.\n* Bishop score \\< 6.\n* Average size of the fetus.\n* Adequate pelvic dimensions.\n* Term or post-term pregnancies with an indication for labor induction either maternal or fetal.\n\nExclusion Criteria:\n\n* • Previous uterine scar.\n\n * Patients with regular uterine contractions.\n * Malpresentation.\n * Multifetal gestation.\n * Prelabour rupture of membranes.\n * Established fetal distress.\n * Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.\n * Antepartum hemorrhage.\n * Active genital herpes infection.\n * Severe maternal illness (e.g. severe preeclampsia).'}, 'identificationModule': {'nctId': 'NCT03544606', 'briefTitle': 'Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor', 'orgStudyIdInfo': {'id': 'ISMN and labor induction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'isosorbide mononitrate group', 'description': 'In vaginal IMN group (group 1) 40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.', 'interventionNames': ['Drug: isosorbide mononitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebos group', 'description': 'In the placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'isosorbide mononitrate', 'type': 'DRUG', 'otherNames': ['Effox 40 mg'], 'description': '40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.', 'armGroupLabels': ['isosorbide mononitrate group']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['pyridoxine'], 'description': 'In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given', 'armGroupLabels': ['placebos group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'faculty of medicine - Kafr Elsheikh university', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'overallOfficials': [{'name': 'Ahmed N Shaker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine - Kafr elsheikh university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data supporting this research is available upon request. Please contact corresponding Author at ahmedafifi38527@postgrad.kasralainy.edu.eg for access to the relevant datasets. We are committed to transparency and facilitating the reproducibility of our findings, and we welcome inquiries regarding the data used in this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ahmed nagy shaker ramadan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kafrelsheikh University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'ahmed nagy shaker ramadan', 'investigatorAffiliation': 'Cairo University'}}}}