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Clinical Trials/NCT03269357
NCT03269357CompletedNot Applicable

Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project

Kristina Gemzell Danielsson1 site in 1 country1,200 target enrollmentStarted: September 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,200
Locations
1
Primary Endpoint
LARC prescriptions (recorded electronic prescriptions)

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention

Other

Clinics randomized to "intervention" will provide structured LARC centered counselling

Intervention: LARC forward structured contraceptive counselling (Other)

Routine counselling

No Intervention

Clinics randomized to routine counselling

Outcomes

Primary Outcomes

LARC prescriptions (recorded electronic prescriptions)

Time Frame: Evaluated at the index visit to the clinic

The rate of women who receive a LARC prescription

Secondary Outcomes

  • LARC placements recorded in patient records(Evaluated at 3months follow up (FU))
  • Contraceptive method used reported by participants(Evaluated at 3,6 and 12 months FU)
  • Satisfaction with the chosen contraceptive method reported by participants(Evaluated at 3,6 and 12 months FU)
  • (Unplanned) pregnancy reported by participants and recorded in patient records(Evaluated at 3,6 and 12 months FU)

Investigators

Sponsor
Kristina Gemzell Danielsson
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Kristina Gemzell Danielsson

Professor

Karolinska Institutet

Study Sites (1)

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