Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-08 @ 3:17 AM
Study NCT ID:
NCT03353012
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2017-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C044815', 'term': 'etonogestrel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2017-10-15', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': 'immediately after contraceptive implant use until 12 weeks after use', 'description': 'To compare treatment-related adverse events between Immediate and delayed breastfeeding postpartum contraceptive users, using case record form which specify bleeding days, spotting days, abdominal discomfort, headache, acne, alopecia, weight and blood pressure of users.'}, {'measure': 'Removal rate of contraceptive implants users', 'timeFrame': 'immediately after contraceptive implant use until 12 weeks after use', 'description': 'To compare tolerance between Immediate and delayed breastfeeding postpartum contraceptive users, by collecting and calculating removal rate of users.'}, {'measure': 'Satisfactory of contraceptive implant users', 'timeFrame': 'immediately after contraceptive implant use until 12 weeks after use', 'description': 'To compare acceptability between Immediate and delayed breastfeeding postpartum contraceptive users, using questionnaire rating satisfactory scale by score from 1 to 5'}], 'secondaryOutcomes': [{'measure': 'Breastfeeding status', 'timeFrame': 'immediately after contraceptive implant use until 12 weeks after use', 'description': "To compare breastfeeding status between Immediate and delayed breastfeeding postpartum contraceptive users by using questionnaire whether each participant is full-breastfeeding, partial-breastfeeding or non-breastfeeding and specify reasons if she's not full-breastfeeding."}, {'measure': 'Child weight', 'timeFrame': 'immediately after contraceptive implant use until 12 weeks after use', 'description': 'To compare child growth by measuring weight, between Immediate and delayed breastfeeding postpartum contraceptive users.'}, {'measure': 'Child height', 'timeFrame': 'immediately after contraceptive implant use until 12 weeks after use', 'description': 'To compare child growth by measuring height, between Immediate and delayed breastfeeding postpartum contraceptive users.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate postpartum implant', 'postpartum implant', 'implant contraception', 'Etonogestrel', 'Levonorgestrel'], 'conditions': ['Breastfeeding', 'Post Partum']}, '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': 'To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.', 'detailedDescription': '* To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.\n* Participants who wish to attend the study will be invited to choose between Levonorgestrel and Etonogestrel contraceptive implant, then they will be randomized into immediate postpartum or delay postpartum group. They will be follow-up at 6 and 12 weeks after receive contraceptive implant.\n* Information about side effects, breastfeeding status, child growth, acceptability and tolerance will be noted using medical records and interviewing, gathering on paper case record forms.\n* Sample size N = 60 (30 in each group (Immediate and delay postpartum group, 15 in each subgroup (Levonogestrel and Etonogestrel group)) This number of sample size is already counted with 10% data loss'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast-feeding post-partum woman aged 18-45 years who wish to use contraceptive implant\n\nExclusion Criteria:\n\n* Pregnant\n* Woman who has any medical conditions which is considered contraindicated to use contraceptive implant\n* Woman with severe antepartum or peripartum complications\n* Woman who is contraindicated to breastfeed.'}, 'identificationModule': {'nctId': 'NCT03353012', 'briefTitle': 'Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant', 'orgStudyIdInfo': {'id': 'Sitanan Lertsiripanich'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levonorgestrel immediate post-partum', 'description': 'Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery', 'interventionNames': ['Drug: Levonorgestrel Drug Implant']}, {'type': 'EXPERIMENTAL', 'label': 'Etonogestrel immediate post-partum', 'description': 'Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery', 'interventionNames': ['Drug: Etonogestrel Drug Implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levonorgestrel delayed post-partum', 'description': 'Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery', 'interventionNames': ['Drug: Levonorgestrel Drug Implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Etonogestrel delayed post-partum', 'description': 'Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 5-7 weeks after child delivery', 'interventionNames': ['Drug: Etonogestrel Drug Implant']}], 'interventions': [{'name': 'Etonogestrel Drug Implant', 'type': 'DRUG', 'otherNames': ['Implanon'], 'description': 'Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.', 'armGroupLabels': ['Etonogestrel delayed post-partum', 'Etonogestrel immediate post-partum']}, {'name': 'Levonorgestrel Drug Implant', 'type': 'DRUG', 'otherNames': ['Jadelle'], 'description': 'Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.', 'armGroupLabels': ['Levonorgestrel delayed post-partum', 'Levonorgestrel immediate post-partum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}], 'overallOfficials': [{'name': 'Unnop Jaisamrarn, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}