Clinical trial NCT03269357: LARC Forward Counselling
Official title: Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy
Keywords: LARC
contraception
counselling
unplanned pregnancy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised trial
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: LARC prescriptions (recorded electronic prescriptions)
timeFrame: Evaluated at the index visit to the clinic
Secondary outcomes:
measure: LARC placements recorded in patient records
timeFrame: Evaluated at 3months follow up (FU)
measure: Contraceptive method used reported by participants
timeFrame: Evaluated at 3,6 and 12 months FU
measure: Satisfaction with the chosen contraceptive method reported by participants
timeFrame: Evaluated at 3,6 and 12 months FU
measure: (Unplanned) pregnancy reported by participants and recorded in patient records
timeFrame: Evaluated at 3,6 and 12 months FU
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: WHO centre, Karolinska University Hospital
Study officials:
References:
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.
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.
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.