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临床试验/NCT05505435
NCT05505435已完成4 期

Continuation Rates of Self-administered Subcutaneous Depot Medroxyprogesterone Acetate and Provider-administered Intramuscular Depot Medroxyprogesterone Acetate in Patients Seeking Post-abortion Contraception

Northwestern University1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
263
试验地点
1
主要终点
DMPA continuation rate

研究概览

简要总结

Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Thus far, studies investigating self-administered DMPA-SC have focused on patients presenting for contraception. Self-administered DMPA-SC has not been widely studied in patients seeking abortion and has been more extensively studied in international settings than in the US. The project will be a prospective cohort study of patients at a large, free-standing abortion clinic in Chicago, Illinois. Patients who indicate that they desire DMPA for post-abortion contraception will be recruited. They will choose either provider-administered DMPA-IM or self-administered DMPA-SC. Patients in both groups will complete a baseline survey that will collect demographic and clinical characteristics. Patients who choose self-administered DMPA-SC will receive self-injection teaching from study staff and will self-inject their first dose of DMPA-SC in the clinic. Patients who choose provider-administered DMPA-IM will receive their first dose of DMPA-IM in the clinic. Both groups will receive a prescription for three additional doses of DMPA and will receive an injection calendar. Study participants will receive a reminder prior to the start of the injection window for their second and third doses. After the injection window for the second and third doses closes, participants will complete follow up surveys. These surveys will assess whether patients received the subsequent doses of DMPA, reasons for discontinuing DMPA for patients who did not receive a dose, pregnancy status, and patient satisfaction with DMPA use. Follow up will be primarily via secure text messaging application with phone calls, email, and mail reserved for patients who cannot or prefer not to be contacted via text message. The primary outcome is continuation rates of DMPA-IM and DMPA-SC at 3 and 6 months after initiation. Secondary outcome measures include pregnancy, adverse effects, and patient satisfaction. We will also determine associations between patients' demographic and clinical characteristics and continuation of DMPA. This project will generate evidence that will support expanding access to DMPA-SC and providing patient education on self-injection, allowing for increased patient contraceptive autonomy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient planning DMPA for post-abortion contraception.

排除标准

  • Patient cannot speak and read English.

研究组 & 干预措施

DMPA-SC

Active Comparator

self-administered subcutaneous depot medroxyprogesterone acetate 104 mg

干预措施: Depot-Medroxyprogestereone Acetate (Drug)

DMPA-IM

Active Comparator

provider-administered intramuscular depot medroxyprogesterone acetate 150 mg

干预措施: Depot-Medroxyprogestereone Acetate (Drug)

结局指标

主要结局

DMPA continuation rate

时间窗: 6 months

Participant use of DMPA 6 months after enrollment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley Turner, MD

Assistant Professor

Northwestern University

研究点 (1)

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