NCT03269357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1.7 years

First QC Date

August 25, 2017

Last Update Submit

August 14, 2020

Conditions

Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy

Keywords

LARCcontraceptioncounsellingunplanned pregnancy

Outcome Measures

Primary Outcomes (1)

  • LARC prescriptions (recorded electronic prescriptions)

    The rate of women who receive a LARC prescription

    Evaluated at the index visit to the clinic

Secondary Outcomes (4)

  • 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

Study Arms (2)

Intervention

OTHER

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

Other: LARC forward structured contraceptive counselling

Routine counselling

NO INTERVENTION

Clinics randomized to routine counselling

Interventions

LARC forward structured contraceptive counsellingOTHER

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

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WHO centre, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (4)

  • Iwarsson KE, Podolskyi V, Bizjak I, Kallner HK, Gemzell-Danielsson K, Envall N. Effects of structured contraceptive counseling in young women: Secondary analyses of a cluster randomized controlled trial (the LOWE trial). Acta Obstet Gynecol Scand. 2024 Nov;103(11):2242-2251. doi: 10.1111/aogs.14954. Epub 2024 Sep 26.

    PMID: 39327830DERIVED

  • 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.

    PMID: 35102001DERIVED

  • 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.

    PMID: 34435347DERIVED

  • 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.

    PMID: 33988917DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomised trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 31, 2017

Study Start

September 1, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)