Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy Clinical Trial
— LOWEOfficial title:
Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project
| NCT number | NCT03269357 |
| Other study ID # | LoWe17 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 1, 2017 |
| Est. completion date | May 31, 2020 |
| Verified date | August 2020 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1200 |
| Est. completion date | May 31, 2020 |
| Est. primary completion date | May 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | WHO centre, Karolinska University Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Kristina Gemzell Danielsson |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | LARC prescriptions (recorded electronic prescriptions) | The rate of women who receive a LARC prescription | Evaluated at the index visit to the clinic | |
| Secondary | LARC placements recorded in patient records | The rate of women who has a LARC method placed following the baseline visit | Evaluated at 3months follow up (FU) | |
| Secondary | Contraceptive method used reported by participants | The rate of women who use a contraceptive method | Evaluated at 3,6 and 12 months FU | |
| Secondary | Satisfaction with the chosen contraceptive method reported by participants | Satisfaction with the prescribed contraceptive method | Evaluated at 3,6 and 12 months FU | |
| Secondary | (Unplanned) pregnancy reported by participants and recorded in patient records | (Unplanned) pregnancy rate | Evaluated at 3,6 and 12 months FU |