Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT04046302
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2019-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015232', 'term': 'Dinoprostone'}], 'ancestors': [{'id': 'D011458', 'term': 'Prostaglandins E'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-07', 'studyFirstSubmitDate': '2019-08-04', 'studyFirstSubmitQcDate': '2019-08-04', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the difference in the pain intensity scores between the study groups', 'timeFrame': '5 minutes', 'description': 'the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IUD Insertion']}, 'referencesModule': {'references': [{'pmid': '32732105', 'type': 'DERIVED', 'citation': 'Ashour AS, Nabil H, Yosif MF, Hussein M, Mageed A Allah AA, Mahmoud M, Abdou H, Kholaif K, Mohamed Kotb MM, El Sharkawy M, Abdelhakim AM, Ali AS, Nassar SA, Abbassy AH, Ghamry NK, Abdel-Latif AA, Taher A, El Mahy M. Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial. Fertil Steril. 2020 Oct;114(4):861-868. doi: 10.1016/j.fertnstert.2020.05.004. Epub 2020 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.', 'detailedDescription': 'Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.\n\nExclusion Criteria:\n\n* currently pregnant or were pregnant within 6 weeks of study entry\n* had a prior attempted or successful IUD insertion\n* had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy\n* any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD\n* active vaginitis or cervicitis\n* undiagnosed abnormal uterine bleeding\n* pelvic inflammatory disease within the last 3 months\n* fibroids or other uterine abnormalities distorting the uterine cavity\n* contraindication or allergy to dinoprostone.'}, 'identificationModule': {'nctId': 'NCT04046302', 'briefTitle': 'Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Self-Administered Vaginal Dinoprostone on Pain Perception During Copper Intrauterine Device Insertion in Parous Women: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'dinoprostone IUD pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dinoprostone', 'description': '1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \\& Upjohn, Puurs, Belgium) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.', 'interventionNames': ['Drug: Dinoprostone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Dinoprostone', 'type': 'DRUG', 'description': '1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \\& Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment.', 'armGroupLabels': ['dinoprostone']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11231', 'city': 'Giza', 'country': 'Egypt', 'facility': 'faculty of medicine Cairo university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'AHMED SAMY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Ahmed Samy aly ashour', 'investigatorAffiliation': 'Cairo University'}}}}