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RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users
Sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri
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.
Official title: Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
348
Start Date
2020-11-24
Completion Date
2025-12-30
Last Updated
2025-06-04
Healthy Volunteers
Yes
Interventions
Additional Standardized Counseling
Research staff will follow a script designed to give unbiased, medically accurate information regarding bleeding changes that may occur with use of a contraceptive ENG implant.
Locations (1)
Planned Parenthood of the St. Louis Region and Southwest Missouri
St Louis, Missouri, United States