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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COMPLETED
39 participants
OBSERVATIONAL
2018-04-16
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women initiating use of an intrauterine device
Women obtaining a copper or hormonal intrauterine device for the purpose of contraception.
A hair sample of approximately 10 (up to 20) hairs cut close to the scalp of the posterior vertex will be taken at the time of IUD insertion, 6 months post-insertion, and 12 months post-insertion.
Mirena
A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Paraguard
A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
Interventions
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Mirena
A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Paraguard
A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-39 years
* Regular menstrual cycles
* Getting an IUD for the purpose of contraception
Exclusion Criteria
* BMI less than 18.5 or greater than 35
* Chronic medical conditions
* Recently pregnant or lactating
18 Years
39 Years
FEMALE
Yes
Sponsors
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Society of Family Planning
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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Nora Doty, MD
Instructor
Principal Investigators
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Nora Doty, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Countries
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References
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Doty N, Beckley E, Garg B, Maristany S, Erikson DW, Jensen JT. Changes in hair cortisol concentration in intrauterine device initiators: A prospective cohort study. Contraception. 2023 Dec;128:110142. doi: 10.1016/j.contraception.2023.110142. Epub 2023 Aug 24.
Other Identifiers
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OHSU IRB 18244
Identifier Type: -
Identifier Source: org_study_id
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