Telemedicine for Contraceptive Counselling- An Open Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-40
SponsorRegion Örebro County

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 16-40 years

Primary reason for use of contraception being pregnancy prevention

Not having pregnancy intentions within 6 months.

Sufficient language skills to understand the study information available in Swedish and English.

Disqualifiers

Women in need for contraceptive method for medical reasons other than protection against unintended pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telemedicine

    Other intervention

    Contraceptive Counselling using the "LOWE Method" and through Tele Health, Video Call with Midwife.

  • Counselling in person visit

    Other intervention

    Contraceptive Counselling using the "LOWE Method". In-person visit with midwife at Maternal Health Clinic.

Treatment groups

772 Participants
are divided into 2 treatment groups
Group A: Counselling through TelemedicineExperimental treatment 1 intervention
Group B: Contraceptive counselling via in-person visitOther 1 intervention

Trial outcomes

Primary outcomes

1

Difference in LARC use

Difference in proportion of women choosing LARC among participants receiving structured contraceptive counselling via telehealth (intervention) compared to in-person visit (control).

Time frame
From enrollment to 12 months.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Örebro County

Lead sponsor

Örebro University, Sweden

Collaborator

Karolinska Institutet

Collaborator

This trial is not recruiting at the moment. You can still explore other options: