Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-02-20 @ 12:33 PM
Study NCT ID:
NCT03829592
Status:
UNKNOWN
Last Update Posted:
2020-05-19
First Post:
2019-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TheEffect of pH on Misoprostol in Induction of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 paralle groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-07-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-16', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of women who will start lactive phase of labour after treatment', 'timeFrame': 'within 24 hours', 'description': 'the number of women in a group who will enter in active labour faster than other groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .', 'detailedDescription': 'Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Full term pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation\n\nExclusion Criteria:\n\n* 1\\. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.'}, 'identificationModule': {'nctId': 'NCT03829592', 'briefTitle': 'TheEffect of pH on Misoprostol in Induction of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies', 'orgStudyIdInfo': {'id': 'Misoprostol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'misoprostol in neutral media', 'description': 'Intervention : misoprostol in a neutral media will be given to women to induce labour', 'interventionNames': ['Drug: misoprostol in a neutral media']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol in acidic media', 'description': 'Intervention : misoprostol in acidic media will be given to induce labour', 'interventionNames': ['Drug: misoprostol in an acidic media']}, {'type': 'SHAM_COMPARATOR', 'label': 'Misoprostol in alkaline media', 'description': 'Intervention : misoprostol in alkaline media will be given to induce labour', 'interventionNames': ['Drug: misoprostol in an alkaline media']}], 'interventions': [{'name': 'misoprostol in a neutral media', 'type': 'DRUG', 'otherNames': ['Drug (misoprostol + neutral media )'], 'description': 'giving misoprostol in a neutral media', 'armGroupLabels': ['misoprostol in neutral media']}, {'name': 'misoprostol in an acidic media', 'type': 'DRUG', 'otherNames': ['Drug ( Misoprostol + acidic media )'], 'description': 'giving misoprostol in an acidic media', 'armGroupLabels': ['Misoprostol in acidic media']}, {'name': 'misoprostol in an alkaline media', 'type': 'DRUG', 'otherNames': ['Drug ( misoprostol + alkaline media )'], 'description': 'giving misoprostol in an alkaline media', 'armGroupLabels': ['Misoprostol in alkaline media']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Alalfy, master', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '+201002611058'}, {'name': 'Ahmed Elgazzar, M.D', 'role': 'CONTACT', 'phone': '+201014005959'}, {'name': 'Mahmoud Alalfy, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Algazeerah and Kasralainy hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Mahmoud Alalfy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}