An observational study in Contraception, Contraceptive Usage and Family Planning, sponsored by University of California, San Diego. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by University of California, San Diego · Observational
The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.
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.
University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients scheduled at UC San Diego for a contraceptive implant after approximately 3 years (32-40 months) of use.
Exclusion Criteria:
Adults who are choosing to get a replacement Nexplanon and agree to track and report their bleeding patterns for one month before replacement and 3 months after.
Device: Track 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.
Number of bleeding days during 4 weeks before replacement
Number of days participants experienced bleeding during the 4 weeks before implant replacement.
Time frame: 4 weeks (28 days) before day of implant replacement.
Number of bleeding days 4 weeks after replacement
Number of days participants experienced bleeding during the 4 weeks after implant replacement.
Time frame: 4 weeks (28 days) after day of implant replacement
Satisfaction with bleeding before 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.
Time frame: 4 weeks (28 days) before day of implant replacement
Satisfaction with bleeding after replacement
Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding after replacement
Time frame: 4 weeks (28 days) after day of implant replacement
Number of bleeding days during the second month after implant replacement
Number of days participants experienced bleeding during the second month after implant replacement
Time frame: Second month (defined as 29-56 days) after implant replacement
Number of bleeding days during the third month post replacement
Number of days participants experienced bleeding during the third month after implant replacement
Time frame: Third month (defined as 57-84 days) after implant replacement
Plan to share: No
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of California, San Diego