Birth Control, Contraception, Contraceptive Usage, Family Planning
Conditions
Keywords
Contraceptive implant, Birth control, Nexplanon
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.
Interventions
OTHERAdditional 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.
Sponsors
Merck Sharp & Dohme LLC
Planned Parenthood of the St. Louis Region and Southwest Missouri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
All study team members will be blinded to the randomization, with the exception of the research member who will be delivering the counseling.
Intervention model description
1:1 fashion with block sizes of 8 using a computer-generated random allocation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed