Telemedicine for Contraceptive Counselling- An Open Randomized Controlled Trial
NCT06896539 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 772
Last updated 2025-03-26
Summary
Protocol Summary:
Sweden has high unintended pregnancy rates, increasing unmet contraceptive needs, and the highest repeat abortion rate in the European Union. Effective contraceptive counseling can improve satisfaction, empower correct use, and increase uptake of long-acting reversible contraceptives (LARC), potentially reducing unintended pregnancies.
Research has explored ways to enhance contraceptive counseling, focusing on increasing LARC use. Interventions that improve access, remove financial barriers, and enhance method-specific knowledge-especially regarding effectiveness-have led to higher LARC adoption and fewer unintended pregnancies and abortions.
The COVID-19 pandemic significantly increased tele-health use for contraceptive counseling. Studies suggest tele-health expands appointment availability, reduces geographic barriers, and improves access to reproductive care, particularly in low-resource populations. However, few studies have examined tele-health's impact on contraceptive counseling, uptake, and satisfaction compared to in-person visits, particularly in Sweden. Before tele-health can be established as a viable family planning option, its counseling quality and impact on LARC adoption must be assessed.
Study Aims:
To determine whether the choice of LARC after tele-health (video) counseling is comparable to in-person counseling with a midwife, using structured contraceptive counseling in both groups.
To assess whether LARC uptake three months post-counseling is similar between women who received tele-health vs. in-person counseling.
This study will provide valuable insights into tele-health's role in contraceptive counseling and its potential to improve access to family planning services.
Conditions
- Unintended Pregnancy Prevention
Interventions
- OTHER
-
Telemedicine
Contraceptive Counselling using the "LOWE Method" and through Tele Health, Video Call with Midwife.
- OTHER
-
Counselling in person visit
Contraceptive Counselling using the "LOWE Method". In-person visit with midwife at Maternal Health Clinic.
Sponsors & Collaborators
-
Örebro University, Sweden
collaborator OTHER - collaborator OTHER
-
Region Örebro County
lead OTHER
Principal Investigators
-
Jan Brynhildsen, PhD · Örebro Universitet, Region Örebro
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2027-06-30
- Completion
- 2029-06-30
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