Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT03269357
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2017-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LARC Forward Counselling
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': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomised trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-14', 'studyFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LARC prescriptions (recorded electronic prescriptions)', 'timeFrame': 'Evaluated at the index visit to the clinic', 'description': 'The rate of women who receive a LARC prescription'}], 'secondaryOutcomes': [{'measure': 'LARC placements recorded in patient records', 'timeFrame': 'Evaluated at 3months follow up (FU)', 'description': 'The rate of women who has a LARC method placed following the baseline visit'}, {'measure': 'Contraceptive method used reported by participants', 'timeFrame': 'Evaluated at 3,6 and 12 months FU', 'description': 'The rate of women who use a contraceptive method'}, {'measure': 'Satisfaction with the chosen contraceptive method reported by participants', 'timeFrame': 'Evaluated at 3,6 and 12 months FU', 'description': 'Satisfaction with the prescribed contraceptive method'}, {'measure': '(Unplanned) pregnancy reported by participants and recorded in patient records', 'timeFrame': 'Evaluated at 3,6 and 12 months FU', 'description': '(Unplanned) pregnancy rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LARC', 'contraception', 'counselling', 'unplanned pregnancy'], 'conditions': ['Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy']}, 'referencesModule': {'references': [{'pmid': '39327830', 'type': 'DERIVED', 'citation': 'Iwarsson KE, Podolskyi V, Bizjak I, Kallner HK, Gemzell-Danielsson K, Envall N. Effects of structured contraceptive counseling in young women: Secondary analyses of a cluster randomized controlled trial (the LOWE trial). Acta Obstet Gynecol Scand. 2024 Nov;103(11):2242-2251. doi: 10.1111/aogs.14954. Epub 2024 Sep 26.'}, {'pmid': '35102001', 'type': 'DERIVED', 'citation': 'Emtell Iwarsson K, Larsson EC, Bizjak I, Envall N, Kopp Kallner H, Gemzell-Danielsson K. Long-acting reversible contraception and satisfaction with structured contraceptive counselling among non-migrant, foreign-born migrant and second-generation migrant women: evidence from a cluster randomised controlled trial (the LOWE trial) in Sweden. BMJ Sex Reprod Health. 2022 Apr;48(2):128-136. doi: 10.1136/bmjsrh-2021-201265. Epub 2022 Jan 31.'}, {'pmid': '34435347', 'type': 'DERIVED', 'citation': 'Envall N, Emtell Iwarsson K, Bizjak I, Gemzell Danielsson K, Kopp Kallner H. Evaluation of satisfaction with a model of structured contraceptive counseling: Results from the LOWE trial. Acta Obstet Gynecol Scand. 2021 Nov;100(11):2044-2052. doi: 10.1111/aogs.14243. Epub 2021 Aug 25.'}, {'pmid': '33988917', 'type': 'DERIVED', 'citation': 'Emtell Iwarsson K, Envall N, Bizjak I, Bring J, Kopp Kallner H, Gemzell-Danielsson K. Increasing uptake of long-acting reversible contraception with structured contraceptive counselling: cluster randomised controlled trial (the LOWE trial). BJOG. 2021 Aug;128(9):1546-1554. doi: 10.1111/1471-0528.16754. Epub 2021 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'Training of health care providers and structured LARC forward counseling may contribute to increased LARC uptake. The hypothesis to be tested is that by introducing LARC forward counselling an increase in LARC usage will be the result as well as decreased unplanned pregnancy and abortion. It is expected that the results of this study will highlight the importance of LARC forward counseling and thus provide the evidence needed to train health care providers and increase access to LARC in youth clinics, midwifery clinics and for post abortion contraception.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At risk for pregnancy (sexually active with men or anticipate becoming sexually active in the next 6 months).\n* Do not desire pregnancy .\n* No contraindications to LARC\n\nExclusion Criteria:\n\n* Undergone tubal ligation or other sterilization procedure.\n* Use of contraceptives for other purposes than contraception'}, 'identificationModule': {'nctId': 'NCT03269357', 'acronym': 'LOWE', 'briefTitle': 'LARC Forward Counselling', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project', 'orgStudyIdInfo': {'id': 'LoWe17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'Clinics randomized to "intervention" will provide structured LARC centered counselling', 'interventionNames': ['Other: LARC forward structured contraceptive counselling']}, {'type': 'NO_INTERVENTION', 'label': 'Routine counselling', 'description': 'Clinics randomized to routine counselling'}], 'interventions': [{'name': 'LARC forward structured contraceptive counselling', 'type': 'OTHER', 'description': 'Training of health care providers (HCPs), use of information material and counselling tools', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'WHO centre, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kristina Gemzell Danielsson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kristina Gemzell Danielsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}