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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03269357
Date of registration: 25/08/2017
Prospective Registration: Yes
Primary sponsor: Kristina Gemzell Danielsson
Public title: LARC Forward Counselling LOWE
Scientific title: Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project
Date of first enrolment: September 1, 2017
Target sample size: 1200
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03269357
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Sweden
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- At risk for pregnancy (sexually active with men or anticipate becoming sexually active
in the next 6 months).

- Do not desire pregnancy .

- No contraindications to LARC

Exclusion Criteria:

- Undergone tubal ligation or other sterilization procedure.

- Use of contraceptives for other purposes than contraception



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy
Intervention(s)
Other: LARC forward structured contraceptive counselling
Primary Outcome(s)
LARC prescriptions (recorded electronic prescriptions) [Time Frame: Evaluated at the index visit to the clinic]
Secondary Outcome(s)
(Unplanned) pregnancy reported by participants and recorded in patient records [Time Frame: Evaluated at 3,6 and 12 months FU]
LARC placements recorded in patient records [Time Frame: Evaluated at 3months follow up (FU)]
Satisfaction with the chosen contraceptive method reported by participants [Time Frame: Evaluated at 3,6 and 12 months FU]
Contraceptive method used reported by participants [Time Frame: Evaluated at 3,6 and 12 months FU]
Secondary ID(s)
LoWe17
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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