LARC Forward Counselling

NCT ID: NCT03269357

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomised trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type OTHER

LARC forward structured contraceptive counselling

Intervention Type OTHER

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

Routine counselling

Clinics randomized to routine counselling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LARC forward structured contraceptive counselling

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kristina Gemzell Danielsson

OTHER

Sponsor Role lead

Responsible Party

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Kristina Gemzell Danielsson

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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WHO centre, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 39327830 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35102001 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34435347 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33988917 (View on PubMed)

Other Identifiers

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LoWe17

Identifier Type: -

Identifier Source: org_study_id

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