Telemedicine for Contraceptive Counselling- An Open Randomized Controlled Trial

NCT06896539 | Not Yet Recruiting DMC

• 1 other identifier: 2023-08130-02
• Study Type: interventional
• Target: 772
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Telemedicine; Contraception; Unintended pregnancy; Counselling

Outcome Measures

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).

  From enrollment to 12 months.

Study Arms (2)

Counselling through Telemedicine

EXPERIMENTAL

Contraceptive counselling using LOWE methodology via telemedicine (video calls).

Other: Telemedicine

Contraceptive counselling via in-person visit

OTHER

Contraceptive counselling using the LOWE methodology via in-person visit.

Other: Counselling in person visit

Interventions

Telemedicine OTHER

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

Also known as: Tele health

Counselling through Telemedicine

Counselling in person visit OTHER

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

Also known as: In person

Contraceptive counselling via in-person visit

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro University, Sweden: collaborator
• Karolinska Institutet: collaborator

MeSH Terms

Interventions

Telemedicine; Counseling

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jan Brynhildsen, PhD

  Örebro Universitet, Region Örebro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Brynhildsen, PhD

CONTACT

+46730694097; jan.brynhildsen@oru.se

Maria Åkesson, RNM

CONTACT

+46704230568; maria.akesson2@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open randomized non-inferiority trial

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share