Contraception, Contraceptive Usage, Family Planning
Conditions
Keywords
Nexplanon, Contraceptive implant
Brief summary
The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.
Detailed description
There is very limited information regarding number of bleeding days after replacement of the contraceptive implants (Nexplanon). More detailed information on this topic will help clinicians counsel patients and help women decide if they would like to pursue contraceptive implant replacement. The investigators will conduct a prospective cohort study of (N=114) among women replacing their contraceptive implant. The primary outcome of the study is the difference in number of bleeding days between the 4-week periods before and after implant replacement. Secondary outcomes include satisfaction with bleeding. Additionally, a secondary outcome will be the number of bleeding days in month 2 and month 3 after replacement of the contraceptive implant. The outcomes will be measured in bleeding diaries and satisfaction surveys. Through a text messaging application, the investigators will send the participants hyperlinks to the diaries/surveys at the stated time points. Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart (Higham). Participants will complete weekly surveys regarding their satisfaction with their bleeding utilizing a Likert scale. The investigators will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.
Interventions
DEVICETrack bleeding patterns before and after implant
Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart. Participants will also complete weekly surveys regarding their satisfaction with their bleeding. We will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.
Sponsors
Merck Sharp & Dohme LLC
University of California, San Diego
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Reproductive aged women 18-50 years old * With a contraceptive implant (for patient participants) * Able to consent in English * Palpable contraceptive implant
Exclusion criteria
* Non-palpable contraceptive implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of bleeding days during 4 weeks before replacement | 4 weeks (28 days) before day of implant replacement. | Number of days participants experienced bleeding during the 4 weeks before implant replacement. |
| Number of bleeding days 4 weeks after replacement | 4 weeks (28 days) after day of implant replacement | Number of days participants experienced bleeding during the 4 weeks after implant replacement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with bleeding before replacement | 4 weeks (28 days) before day of implant replacement | Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding before implant replacement. |
| Satisfaction with bleeding after replacement | 4 weeks (28 days) after day of implant replacement | Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding after replacement |
| Number of bleeding days during the second month after implant replacement | Second month (defined as 29-56 days) after implant replacement | Number of days participants experienced bleeding during the second month after implant replacement |
| Number of bleeding days during the third month post replacement | Third month (defined as 57-84 days) after implant replacement | Number of days participants experienced bleeding during the third month after implant replacement |
Countries
United States
Outcome results
None listed