Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT03404102
Status:
UNKNOWN
Last Update Posted:
2018-01-19
First Post:
2018-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discontinuation Rate Among Copper IUD Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-12', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure discontinuation rate', 'timeFrame': '1 year', 'description': '• To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic.'}], 'secondaryOutcomes': [{'measure': 'exclude anemia', 'timeFrame': '1 year', 'description': 'To exclude Anemia from reasons of Cu-IUD discontinuation.'}, {'measure': 'comparison', 'timeFrame': '1 year', 'description': '• To identify reasons of discontinuation among Copper IUD users and percentage of each cause in both university clinic and primary health care unit.'}, {'measure': 'users" satisfaction', 'timeFrame': '1 year', 'description': "• To measure copper IUD users' satisfaction of this contraceptive method in both university clinic and primary health care unit."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraceptive Device; Intrauterine']}, 'descriptionModule': {'briefSummary': 'The intrauterine device (IUD) is one of the most widely used reversible, long-term contraceptive methods in the world. But despite all its advantages; discontinuation rate of IUD ranged from 9.6% to 37.3 % (according to Demographic and Health Surveys data). In Egypt, in 2014, the discontinuation rate of IUD (within 12 months of use) was 14.3%.This study explores the differences around this rate in Egyptian university clinic and primary healthcare clinic with detailed percentages of possible causes.', 'detailedDescription': 'The aim of the study is to compare between primary health care unit and university family planning clinic in discontinuation rate among copper IUD users.\n\n1. The Research Hypothesis: (Null hypothesis)\n\n • In women using copper IUD, discontinuation rate in primary health care unit and university clinic may be similar.\n2. The Research Question:\n\n • In women using copper IUD, Does discontinuation rate in primary health care unit and university clinic differ?\n3. METHODOLOGY:\n\nPatients and Methods\n\n• Study setting:\n\n* Family planning Outpatient clinic of Ain Shams Maternity Hospital, (ASUMH)\n* primary health care unit in ain shams area\n\n • Study population:\n* Study period: 1 year\n* Sample size: was calculated using Sample size computer program 11. After review of literature, no previous similar study was done before, so assume a discontinuation rate of 50% among Cu-IUD users in primary healthcare unit and 25% among Cu-IUD users in university clinic. Based on these values; the study will include 170 Cu-IUD users; equally selected as 85 subjects from each clinic. But due to the expected drop outs, recruitment will start by 200 women from each clinic.\n\n * Statistics:\n\n * Descriptive statistics for measured variables will be expressed as range, mean and standard deviation (for metric data); range, median and interquartile range (for discrete data); and number and proportions (for categorical data). Cu-IUD discontinuation findings in each clinic will be compared using the t-test or the Mann-whitney U test depending on whether the measured parameters are guassian variables. A P-value of 0.05 or less will be considered statistically significant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women attending family planning for Cu- IUD insertion who meet inclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Age from 18-49 years. 2. Women planning for Cu-IUD insertion as a contraceptive method.\n\nExclusion Criteria:\n\n* 1\\. Any woman with condition included in Category 3 or 4 for Cu-IUD in medical eligibility criteria for contraceptive use (MEC) -World Health Organization-2015.'}, 'identificationModule': {'nctId': 'NCT03404102', 'briefTitle': 'Discontinuation Rate Among Copper IUD Users', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Discontinuation Rates Among Copper Intrauterine Device Users in Primary Healthcare Unit and University Clinic. Is There a Difference?', 'orgStudyIdInfo': {'id': 'Cu-IUD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'university clinic', 'description': '* Enrollment: 200 Subjects will be enrolled from women attending family planning clinic for Cu- IUD insertion\n* Informed Consent: All participants will give their informed consent prior to enrollment.\n* Data collection \\& recording: Data of each patient will be recorded in a Case Record Form (CRF).\n* Follow up visits /questionnaire: will be conducted from each subject at 6 months and 12 months after Cu-IUD insertion. User satisfaction score and haemoglobin serum level will be included in the questionnaire.', 'interventionNames': ['Device: Cu-IUD']}, {'label': 'primary healthcare unit clinic', 'description': '* Enrollment: 200 Subjects will be enrolled from women attending family planning clinic for Cu- IUD insertion\n* Informed Consent: All participants will give their informed consent prior to enrollment.\n* Data collection \\& recording: Data of each patient will be recorded in a Case Record Form (CRF).\n* Follow up visits /questionnaire: will be conducted from each subject at 6 months and 12 months after Cu-IUD insertion. User satisfaction score and haemoglobin serum level will be included in the questionnaire.', 'interventionNames': ['Device: Cu-IUD']}], 'interventions': [{'name': 'Cu-IUD', 'type': 'DEVICE', 'description': 'Copper Intra-uterine device used as contraceptive method', 'armGroupLabels': ['primary healthcare unit clinic', 'university clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Ain Shams', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ain Shams Maternity hospital', 'role': 'CONTACT', 'email': 'socea@socea.org', 'phone': '02-26845870', 'phoneExt': '202'}], 'facility': 'Ain Shams Maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'noha elzaydy, M.B.B.Ch.', 'role': 'CONTACT', 'email': 'nohaelzaydy@gmail.com', 'phone': '01008309518', 'phoneExt': '202'}], 'overallOfficials': [{'name': 'Ain Shams Maternity Hospital', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams Maternity Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'noha mohamed elzaydy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'noha mohamed elzaydy', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}