Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01236651
Status:
UNKNOWN
Last Update Posted:
2010-11-09
First Post:
2010-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008614', 'term': 'Meperidine'}, {'id': 'C005317', 'term': 'drotaverin'}], 'ancestors': [{'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the duration of the first stage of labor', 'timeFrame': '6 monthes', 'description': 'the primary outcome is to evaluate whether meperidine or drotaverine is more effective in shortening the duration of the 1st stage of labor'}, {'measure': 'effect on the duration of the 1st stage of labor', 'timeFrame': '6 monthes', 'description': 'the primary outcome is to evaluate whether meperidine or drotaverine is more effective on the duration of the 1st stage of labor'}], 'secondaryOutcomes': [{'measure': 'effect on pain', 'timeFrame': '6 monthes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae']}, 'descriptionModule': {'briefSummary': 'Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae', 'detailedDescription': 'Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae\n\nProtocol of Thesis Submitted for partial fulfillment of master degree in Obstetrics \\& Gynecology\n\nThe aim of this work is to compare and to evaluate the efficacy of drotaverine hydrochloride versus meperidine hydrochloride on the duration of the 1st stage of labor.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: ● primigravida.\n\n* Singleton pregnancy.\n* Term gestation i.e, 38-41 weeks.\n* Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.\n* Vertex presentation with occipito anterior position.\n* Efficient uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.\n\nExclusion Criteria: ● Abnormal presentation or occipito posterior position.\n\n* Multiple pregnancies.\n* Cephalo-pelvic disproportion.\n* Cervical surgery in the past or history of cervical injury.\n* Patients on antihypertensive therapy.\n* Known hypersensitivity to drotaverine or meperidine.\n* If any other spasmolytic agent had been used within 48 hours.'}, 'identificationModule': {'nctId': 'NCT01236651', 'briefTitle': 'Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae', 'orgStudyIdInfo': {'id': 'dr hegab protocol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'meperidine and duration of 1st stage of labor', 'description': 'meperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor', 'interventionNames': ['Drug: Meperidine']}, {'type': 'EXPERIMENTAL', 'label': 'drotaverine and duration of 1st stage of labor', 'description': 'drotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor', 'interventionNames': ['Drug: Drotaverine']}], 'interventions': [{'name': 'Meperidine', 'type': 'DRUG', 'description': 'administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor', 'armGroupLabels': ['meperidine and duration of 1st stage of labor']}, {'name': 'Drotaverine', 'type': 'DRUG', 'description': 'administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor', 'armGroupLabels': ['drotaverine and duration of 1st stage of labor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'role': 'CONTACT', 'phone': '0020106981179'}, {'role': 'CONTACT', 'phone': '0020123033223'}], 'facility': 'Mahmoud', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'mahmoud mohamed', 'role': 'CONTACT', 'email': 'hegab_2008@yahoo.com', 'phone': '0020106981179'}, {'name': 'M H', 'role': 'CONTACT', 'email': 'hegab_2008@yahoo.com', 'phone': '0020114440015'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'ain shams university', 'oldOrganization': 'ain shams university'}}}}