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临床试验/NCT01019369
NCT01019369已完成不适用

Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate

Carolyn L. Westhoff1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
1
主要终点
Number of Participants Continuing DMPA at 6 Months

研究概览

简要总结

Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.

详细描述

Unintended pregnancy remains a worldwide problem in both developed and developing countries. In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6 million women annually are at high risk of becoming unintentionally pregnant because of a gap in contraceptive use, and disadvantaged women are more likely to have more difficulty than others with continuous method use. Multiple strategies have been explored and implemented to increase the effective usage of contraception, including promoting the use of longer acting reversible contraceptives.

Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting is possible. The acceptability of self administered DMPA has also been reviewed, with favorable outcomes; however, the actual intervention has not been studied.

This study will recruit women presenting for abortion or contraceptive services at the Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special Gynecology Services who desire DMPA for contraception. Women will be randomized to two groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary objective of this study is to compare the continuation rates of SC DMPA between the self and clinic administration groups at 6 months. Secondary outcomes include participant satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method continuation or discontinuation, evidence of persistent skin changes following administration of SC DMPA, and need for continued clinical support.

研究设计

研究类型
Interventional
分配方式
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

  • age greater than or equal to 18 years
  • seeking DMPA for contraception
  • English or Spanish speaking
  • consistent access to a working telephone
  • availability for follow up for one year

排除标准

  • suspected or continuing pregnancy
  • undiagnosed vaginal bleeding
  • known or suspected breast cancer
  • acute liver disease
  • known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
  • desire for pregnancy within one year

研究组 & 干预措施

Self Administration of DMPA

Experimental

Self administration of subcutaneous depot medroxyprogesterone acetate

干预措施: Medroxyprogesterone 17-Acetate (Drug)

Clinic administration of DMPA

Active Comparator

Clinic administration (routine care) of DMPA

干预措施: Medroxyprogesterone 17-Acetate (Drug)

结局指标

主要结局

Number of Participants Continuing DMPA at 6 Months

时间窗: 6 months

The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA

次要结局

  • Number of Participants Continuing DMPA(3, 9, 12 months)
  • Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available(6, 12 months)
  • Prevalence of Participants With Persistent Skin Changes(12 months)
  • Scaled Satisfaction Score(6, 12 months)
  • Average Minutes Spent Getting Ready for and Giving the Injection(0-12 months)

研究者

发起方
Carolyn L. Westhoff
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carolyn L. Westhoff

Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology

Columbia University

研究点 (1)

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