Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-26 @ 12:59 AM
Study NCT ID:
NCT03492034
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2018-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IUD Insertion During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2018-03-24', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IUD expulsion rate', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Bleeding', 'timeFrame': '6 weeks', 'description': 'number of pads changed per day'}, {'measure': 'Degree of Pain', 'timeFrame': '6 weeks', 'description': 'Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)'}, {'measure': 'dyspareunia', 'timeFrame': '6 weeks', 'description': 'Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)'}, {'measure': 'patient satisfaction', 'timeFrame': '6 weeks', 'description': 'Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '36302159', 'type': 'DERIVED', 'citation': 'Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant woman aged between 18 to 40 years old.\n2. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.\n3. Body mass index between 19-30 kg/m2\n4. Seeking contraception after delivery.\n\nExclusion Criteria:\n\n1. History of menorrhagia or severe dysmenorrhea.\n2. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).\n3. Patients who have bleeding disorders.\n4. Anemia (Hb \\< 9 g %).\n5. Chronic depilating diseases reducing immunity such as Diabetes.\n6. Structural uterine anomaly or large uterine fibroids distorting anatomy.\n7. History of previous IUD expulsion or removal for complications.\n8. Unexplained uterine bleeding.\n9. Copper allergy or Wilson disease.\n10. Gestational trophoblastic disease with persistently elevated Beta HCG.\n11. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).\n12. Complications during cesarean section e.g. postpartum hemorrhage.\n13. Cesarean section during placenta previa.'}, 'identificationModule': {'nctId': 'NCT03492034', 'briefTitle': 'IUD Insertion During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AS1750'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IUD during CS', 'interventionNames': ['Device: IUD during CS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IUD after puerperium', 'interventionNames': ['Device: IUD after puerperium']}], 'interventions': [{'name': 'IUD during CS', 'type': 'DEVICE', 'description': 'IUD insertion during CS', 'armGroupLabels': ['IUD during CS']}, {'name': 'IUD after puerperium', 'type': 'DEVICE', 'description': 'IUD after puerperium', 'armGroupLabels': ['IUD after puerperium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed S Sweed, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}