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

University of California San Diego

Status: Active, not recruiting

Conditions: Family Planning; Contraception; Contraceptive Usage

Treatments: Device: Track bleeding patterns before and after implant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04725643

201908

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

55 participants in 1 patient group

Implant Group

Description:

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.

Treatment:

Device: Track bleeding patterns before and after implant