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

Planned Parenthood of the St. Louis Region and Southwest Missouri

Status and phase

Active, not recruiting

Phase 4

Conditions

Family Planning

Contraception

Contraceptive Usage

Birth Control

Treatments

Other: Additional Standardized Counseling

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04558229

MSD201959528

Details and patient eligibility

About

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.

Enrollment

348 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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