Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On
NCT ID: NCT04725643
Last Updated: 2024-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
55 participants
OBSERVATIONAL
2022-02-17
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Implant Group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* With a contraceptive implant (for patient participants)
* Able to consent in English
* Palpable contraceptive implant
Exclusion Criteria
18 Years
50 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of California, San Diego
OTHER
Responsible Party
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Sheila Mody
Associate Professor
Principal Investigators
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Sheila Mody, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
La Jolla, California, United States
Countries
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References
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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.
Other Identifiers
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201908
Identifier Type: -
Identifier Source: org_study_id
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