Ignite Creation Date:
2025-12-17 @ 1:44 PM
Ignite Modification Date:
2025-12-23 @ 10:23 PM
Study NCT ID:
NCT04646161
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2020-11-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2020-11-07', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale', 'timeFrame': 'During the intervention', 'description': 'By using the visual analogue score'}], 'secondaryOutcomes': [{'measure': 'cervical dilataion < 4 mm', 'timeFrame': 'During the intervention', 'description': 'need for cervical dilatation to pass the IUD'}, {'measure': 'Pain at insertion according to VAS', 'timeFrame': 'During the intervention', 'description': 'By using the visual analogue score'}, {'measure': 'Subjective sensation of satisfaction graduated as VAS like scale', 'timeFrame': 'During the intervention', 'description': 'By using the visual analogue score like system'}, {'measure': 'side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting', 'timeFrame': 'During the intervention', 'description': 'Bleeding by using the soaked bads'}, {'measure': 'side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia', 'timeFrame': 'During the first 24 hours'}, {'measure': 'side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion', 'timeFrame': 'After 30 days of intervention'}, {'measure': 'Duration of insertion(min)', 'timeFrame': 'During the intervention', 'description': 'From start of procedure till removing the speculum'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics \\& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,', 'detailedDescription': "The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'female patients during the lactational amenorrhea who undergo Mirena IUD insertion after had been delivered by CS within 6 monthes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1- Women in lactational amenoeehea with pregnancy test negative 2- Women who had caesarean section within 6 monthes of IUD insertion 3- No medical disorders\n\nExclusion Criteria:\n\n* 1- Women in regular menses 2- Medical disorders 3- Nulligravida or muligravida with NVD 4- Women with history of Previous CS more than one CS 5- Any congenital uterine anomalies, fibroids and adenomysis 6- Chronic pelvic pain 7- Intrauterine adhesions 8- Spasmodic dysmenohrrea 9- Allergy to misoprostol'}, 'identificationModule': {'nctId': 'NCT04646161', 'briefTitle': 'Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea', 'orgStudyIdInfo': {'id': 'professor'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'prostaglandins before iud insertion group', 'description': 'this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion', 'interventionNames': ['Drug: Misoprostol']}, {'label': 'placebo group', 'description': 'this group will receive placebo tablet before mirena iud insertion'}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'description': 'misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion', 'armGroupLabels': ['prostaglandins before iud insertion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hany saad, assistant prof', 'role': 'CONTACT', 'email': 'hanysaad25280@gmail.com', 'phone': '01001817211'}, {'name': 'hadeer meshaal, ass prof', 'role': 'CONTACT', 'email': 'dr_hadeer@live.com', 'phone': '01001435238'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'hany saad, assisstant prof', 'role': 'CONTACT', 'email': 'hanysaad25280@gmail.com', 'phone': '01001817211'}, {'name': 'hadeer meshaal, assistant prof', 'role': 'CONTACT', 'email': 'dr_hadeer@live.com', 'phone': '01001435238'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'Hany saad', 'investigatorAffiliation': 'Cairo University'}}}}