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

Active, not recruiting

• Conditions: Family Planning; Contraception; Contraceptive Usage
• Interventions: Device: Track bleeding patterns before and after implant

• Registration Number: NCT04725643
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Study Start: 2022-02-17
• Status Verified: 2024-01
• Primary Completion: 2024-01-11
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-23
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Implant Group	Track bleeding patterns before and after implant	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States