Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-29 @ 8:47 AM
Study NCT ID:
NCT06550232
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IV PAPAVERINE Prior to Propess for Labor Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010208', 'term': 'Papaverine'}], 'ancestors': [{'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The group allocation will be double blind. The randomization table will be available only to one member of the study, who will prepare the medications according to the allocated intervention. Participants will receive intravenous 0.9% normal saline with or without papaverine. The same bottles of normal saline will be use for the papaverine and placebo groups. Accordingly, the participants will be masked for the intervention. The participants, the researchers including the obstetricians who inserted the PGE2 (propess), the caregiver nurse who administrated the medication, the data collector, and the statistician will be blinded to the group allocations throughout the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-22', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta Bishop score', 'timeFrame': '24 hours', 'description': 'The bishop score before and after propess insertion'}, {'measure': 'the time from propess insertion until delivery', 'timeFrame': '72 hours', 'description': 'induction to delivery time'}], 'secondaryOutcomes': [{'measure': 'maternal satisfaction scores', 'timeFrame': '24 hours', 'description': 'maternal satisfaction on 1-5 scale. higher scores mean higher satisfaction'}, {'measure': 'visual analogue scale score', 'timeFrame': '24 hours', 'description': 'pain assessment using a 10-point visual analogue scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['labor induction', 'papaverine', 'propess', 'bishop score', 'induction to delivery interval'], 'conditions': ['Induced Vaginal Delivery']}, 'referencesModule': {'references': [{'pmid': '21152844', 'type': 'BACKGROUND', 'citation': 'Oliveira MV, Oberst PV, Leite GK, Aguemi A, Kenj G, Leme VD, Sass N. [Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial]. Rev Bras Ginecol Obstet. 2010 Jul;32(7):346-51. doi: 10.1590/s0100-72032010000700007. Portuguese.'}, {'pmid': '22895986', 'type': 'BACKGROUND', 'citation': 'Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD009243. doi: 10.1002/14651858.CD009243.pub2.'}, {'pmid': '14698825', 'type': 'BACKGROUND', 'citation': 'Singh KC, Jain P, Goel N, Saxena A. Drotaverine hydrochloride for augmentation of labor. Int J Gynaecol Obstet. 2004 Jan;84(1):17-22. doi: 10.1016/s0020-7292(03)00276-5.'}, {'pmid': '24299975', 'type': 'BACKGROUND', 'citation': 'Ibrahim MI, Alzeeniny HA, Ellaithy MI, Salama AH, Abdellatif MA. Drotaverine to improve progression of labor among nulliparous women. Int J Gynaecol Obstet. 2014 Feb;124(2):112-7. doi: 10.1016/j.ijgo.2013.08.013. Epub 2013 Nov 7.'}, {'pmid': '19644697', 'type': 'BACKGROUND', 'citation': 'Madhu C, Mahavarkar S, Bhave S. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour. Arch Gynecol Obstet. 2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-1188-8. Epub 2009 Jul 31.'}, {'pmid': '19664769', 'type': 'BACKGROUND', 'citation': 'Yilmaz B, Kart C, Kelekci S, Gokturk U, Sut N, Tarlan N, Mollamahmutoglu L. Meperidine versus valethamate bromide in shortening the duration of active labor. Int J Gynaecol Obstet. 2009 Nov;107(2):126-9. doi: 10.1016/j.ijgo.2009.06.021. Epub 2009 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval.\n\nResearchers will compare drug papaverine to a placebo', 'detailedDescription': 'More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (\\<6), are prone to higher induction failure rates and are candidates for cervical ripening.\n\nThe cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton term pregnancy\n* bishop score\n* need for labor induction with PGE2\n* vertex presentation\n* viable fetus\n\nExclusion Criteria:\n\n* Prelabour rupture of membrane\n* Twins pregnancy\n* previous cesarean section\n* allergy to the study medication\n* fetal anomaly contraindications for vaginal delivery\n* maternal supraventricular tachicardia'}, 'identificationModule': {'nctId': 'NCT06550232', 'briefTitle': 'IV PAPAVERINE Prior to Propess for Labor Induction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'The Effect of IV PAPAVERINE 80 mg Prior to Propess on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '0112-24-NHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'papaverine arm', 'description': 'IV-papaverine 80 mg in 100 ml 0.9% saline, once', 'interventionNames': ['Drug: Papaverine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'I.V 100 ml 0.9% saline', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Papaverine', 'type': 'DRUG', 'description': 'Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline', 'armGroupLabels': ['papaverine arm']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'I.V Sallne', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nahariya', 'country': 'Israel', 'facility': 'Galilee Medical Center', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'The authors are willing to share the data of the study upon request of the Editors.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Fetal Maternal Unit', 'investigatorFullName': 'Dr. Maya Wolf', 'investigatorAffiliation': 'Western Galilee Hospital-Nahariya'}}}}