LARC Forward Counselling (LOWE)

August 14, 2020 updated by: Kristina Gemzell Danielsson

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • WHO centre, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention
Clinics randomized to "intervention" will provide structured LARC centered counselling
Other: LARC forward structured contraceptive counselling
Training of health care providers (HCPs), use of information material and counselling tools
No Intervention: Routine counselling
Clinics randomized to routine counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LARC prescriptions (recorded electronic prescriptions)
Time Frame: Evaluated at the index visit to the clinic
The rate of women who receive a LARC prescription
Evaluated at the index visit to the clinic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LARC placements recorded in patient records
Time Frame: Evaluated at 3months follow up (FU)
The rate of women who has a LARC method placed following the baseline visit
Evaluated at 3months follow up (FU)
Contraceptive method used reported by participants
Time Frame: Evaluated at 3,6 and 12 months FU
The rate of women who use a contraceptive method
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
Satisfaction with the prescribed contraceptive method
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
(Unplanned) pregnancy rate
Evaluated at 3,6 and 12 months FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kristina Gemzell Danielsson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LoWe17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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