Impact of Contraceptive Counselling on LARC Uptake and Unplanned PregnancyLOWENCT03269357
LARC Forward Counselling
A study testing LARC forward structured contraceptive counselling in people with Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy, run by Kristina Gemzell Danielsson at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy
- What is being tested?
- LARC forward structured contraceptive counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Undergone tubal ligation or other sterilization procedure.
- Use of contraceptives for other purposes than contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project
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.
- Being tested
- LARC forward structured contraceptive counselling
- Keywords
- LARC, contraception, counselling, unplanned pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARC forward structured contraceptive counsellingOther
Training of health care providers (HCPs), use of information material and counselling tools
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Clinics randomized to "intervention" will provide structured LARC centered counselling Receives: Other: LARC forward structured contraceptive counselling |
| Routine counselling | No intervention | Clinics randomized to routine counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
LARC prescriptions (recorded electronic prescriptions)
The rate of women who receive a LARC prescription
Measured: Evaluated at the index visit to the clinic
Secondary outcomes (4)
LARC placements recorded in patient records
The rate of women who has a LARC method placed following the baseline visit
Measured: Evaluated at 3months follow up (FU)
Contraceptive method used reported by participants
The rate of women who use a contraceptive method
Measured: Evaluated at 3,6 and 12 months FU
Satisfaction with the chosen contraceptive method reported by participants
Satisfaction with the prescribed contraceptive method
Measured: Evaluated at 3,6 and 12 months FU
(Unplanned) pregnancy reported by participants and recorded in patient records
(Unplanned) pregnancy rate
Measured: Evaluated at 3,6 and 12 months FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Sep 2017
- Primary completion31 May 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Impact of Contraceptive Counselling on LARC Uptake and Unplanned PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised trial
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristina Gemzell Danielsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristina Gemzell Danielsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269357
- Sponsor's protocol ID
- LoWe17
- Acronym
- LOWE
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2017
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39327830Emtell 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 35102001Envall 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 34435347Emtell 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project
- ClinicalTrials.gov ID
- NCT03269357
- Acronym / sponsor ID
- LOWE / LoWe17
- Keywords
- LARC, contraception, counselling, unplanned pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Kristina Gemzell DanielssonUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomised trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: LARC forward structured contraceptive counsellingClinics randomized to "intervention" will provide structured LARC centered counselling |
| Routine counselling | No intervention | –Clinics randomized to routine counselling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Undergone tubal ligation or other sterilization procedure.
- Use of contraceptives for other purposes than contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LARC forward structured contraceptive counsellingTraining of health care providers (HCPs), use of information material and counselling tools | Other | Intervention |
Primary outcome
LARC prescriptions (recorded electronic prescriptions)
Time frame: Evaluated at the index visit to the clinic
The rate of women who receive a LARC prescription
4 secondary outcomes
LARC placements recorded in patient records
Time frame: Evaluated at 3months follow up (FU)
Contraceptive method used reported by participants
Time frame: Evaluated at 3,6 and 12 months FU
Satisfaction with the chosen contraceptive method reported by participants
Time frame: Evaluated at 3,6 and 12 months FU
(Unplanned) pregnancy reported by participants and recorded in patient records
Time frame: Evaluated at 3,6 and 12 months FU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Derived from this study: PubMed 39327830Iwarsson 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.
- Derived from this study: PubMed 35102001Emtell 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.
- Derived from this study: PubMed 34435347Envall 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.
- Derived from this study: PubMed 33988917Emtell 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LARC forward structured contraceptive counselling in people with Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy, run by Kristina Gemzell Danielsson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LARC prescriptions (recorded electronic prescriptions) (time frame: Evaluated at the index visit to the clinic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269357, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020; AzTrials last refreshed its copy on 29 Oct 2026.