Clinical trial NCT04725643: Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On
Official title: Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Contraception
Contraceptive Usage
Family Planning
Keywords: Nexplanon, Contraceptive implant
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-01-27
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled at UC San Diego for a contraceptive implant after approximately 3 years (32-40 months) of use.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of bleeding days during 4 weeks before replacement
timeFrame: 4 weeks (28 days) before day of implant replacement.
measure: Number of bleeding days 4 weeks after replacement
timeFrame: 4 weeks (28 days) after day of implant replacement
Secondary outcomes:
measure: Satisfaction with bleeding before replacement
timeFrame: 4 weeks (28 days) before day of implant replacement
measure: Satisfaction with bleeding after replacement
timeFrame: 4 weeks (28 days) after day of implant replacement
measure: Number of bleeding days during the second month after implant replacement
timeFrame: Second month (defined as 29-56 days) after implant replacement
measure: Number of bleeding days during the third month post replacement
timeFrame: Third month (defined as 57-84 days) after implant replacement
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Sheila Mody, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x.