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

No results posted yet for this study

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
  • Karolinska Institutet

    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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06896539 on ClinicalTrials.gov