RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users

Phase 4

Recruiting

• Conditions: Contraception; Contraceptive Usage; Birth Control; Family Planning
• Interventions: Other: Additional Standardized Counseling

• Registration Number: NCT04558229
• Lead Sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri

Brief Summary

Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-22
• Study Start: 2020-11-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-11-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 348

Inclusion Criteria

• Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
• Ability to consent in English

Exclusion Criteria

• Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional Standardized Counseling	Additional Standardized Counseling	-

Primary Outcome Measures

Name	Time	Method
Nexplanon Discontinuation Rates	6 months	Based subjects' self-reported ability to cope with various changes in bleeding patterns, and other demographic information, we will analyze whether an association exists between those who discontinue their method use early due to troublesome bleeding and the counseling they received on the day of method insertion.

Trial Locations

Locations (1)

Planned Parenthood of the St. Louis Region and Southwest Missouri; 🇺🇸 Saint Louis, Missouri, United States