Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On

Study Overview
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Brief Summary
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The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.

Detailed Description
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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.

Official Title
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Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On

Conditions
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Contraception, Contraceptive Usage, Family Planning

Intervention / Treatment
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* Device: Track bleeding patterns before and after implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implant Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bleeding days during 4 weeks before replacement | Number of days participants experienced bleeding during the 4 weeks before implant replacement. | 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. | 4 weeks (28 days) after day of implant replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | Third month (defined as 57-84 days) after implant replacement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nexplanon, Contraceptive implant