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CompletedNCT03269357LOWEUpdated Aug 18, 2020

LARC Forward Counselling

An interventional study of LARC forward structured contraceptive counselling in Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy, sponsored by Kristina Gemzell Danielsson. Completed at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-18.

Sponsored by Kristina Gemzell Danielsson · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy

Keywords

  • LARC
  • contraception
  • counselling
  • unplanned pregnancy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Undergone tubal ligation or other sterilization procedure.
  • Use of contraceptives for other purposes than contraception
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,200 participants (actual)

Study arms

  • Other
    Intervention

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

    Other: LARC forward structured contraceptive counselling

  • No intervention
    Routine counselling

    Clinics randomized to routine counselling

Interventions

  • OtherLARC forward structured contraceptive counselling

    Training of health care providers (HCPs), use of information material and counselling tools

05

What researchers measure

Primary outcomes

  1. LARC prescriptions (recorded electronic prescriptions)

    The rate of women who receive a LARC prescription

    Time frame: Evaluated at the index visit to the clinic

Secondary outcomes

  1. LARC placements recorded in patient records

    The rate of women who has a LARC method placed following the baseline visit

    Time frame: Evaluated at 3months follow up (FU)

  2. Contraceptive method used reported by participants

    The rate of women who use a contraceptive method

    Time frame: Evaluated at 3,6 and 12 months FU

  3. Satisfaction with the chosen contraceptive method reported by participants

    Satisfaction with the prescribed contraceptive method

    Time frame: Evaluated at 3,6 and 12 months FU

  4. (Unplanned) pregnancy reported by participants and recorded in patient records

    (Unplanned) pregnancy rate

    Time frame: Evaluated at 3,6 and 12 months FU

06

Study locations

1 site
  • WHO centre, Karolinska University Hospital
    Stockholm, 17176, Sweden
07

References and documents

Publications

  • 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. PubMed 35102001 ↗
  • 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. PubMed 34435347 ↗
  • 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. PubMed 33988917 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03269357
Lead sponsor
Kristina Gemzell Danielsson
Responsible party
Kristina Gemzell Danielsson (Professor, Karolinska Institutet) — Sponsor-investigator
First posted
Aug 31, 2017
Start date
Sep 1, 2017
Primary completion
May 31, 2019
Completion
May 31, 2020
Last update
Aug 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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