Continuation of Subcutaneous and Intramuscular Injectable Contraception: a Non-randomized Prospective Cohort Study in Punjab, Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Jhpiego
- 入组人数
- 1,009
- 试验地点
- 41
- 主要终点
- DMPA continuation rate
研究概览
简要总结
The aim of this study is to assess the value proposition of expanding contraceptive options available to women in Punjab, Pakistan to include subcutaneous depot medroxyprogesterone acetate (DMPA-SC).
Specific objectives are:
- To compare 12-month continuation rates for DMPA-SC and intramuscular DMPA (DMPA-IM) among married women 18- 49 years of age in two districts of Punjab, Pakistan
- To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
- To assess how well women opting for self-injection of DMPA-SC adhere to standards for commodity storage, injection timing, injection technique, and waste disposal
详细描述
Depot medroxyprogesterone acetate (DMPA) is a highly-effective, injectable contraceptive method that requires injections every 11 to 17 weeks. It is available in both intramuscular (IM) and subcutaneous (SC) formulations, which are therapeutically equivalent and have similar safety profiles. DMPA-IM has been included in the method mix for most countries for many years. DMPA-SC is a newer formulation being added to the method mix in select settings. Studies demonstrate that self-administration of subcutaneous DMPA (DMPA-SC) outside clinical settings is safe, effective, feasible, acceptable, and can improve continuation, and a recommendation in favor of self-injected DMPA-SC is included in WHO guidelines on self-care interventions for health and well-being.
The Bill and Melinda Gates Foundation is funding implementation research in multiple countries to understand how self-injection of DMPA-SC can best be introduced to specific markets to expand the contraceptive options available to women and girls, health system characteristics, the demand for self-injection when DMPA-SC is offered alongside a range of other methods, and women's and girl's ability to start and continue use. Jhpiego has received funding to conduct one of these 'market tests' in Punjab, Pakistan.
The aim of this study is to assess the value proposition of expanding contraceptive options available to women in Punjab, Pakistan to include subcutaneous depot medroxyprogesterone acetate (DMPA-SC).
Specific objectives are:
- To compare 12-month continuation rates for DMPA-SC and intramuscular DMPA (DMPA-IM) among married women 18- 49 years of age in two districts of Punjab, Pakistan
- To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
- To assess how well women opting for self-injection of DMPA-SC adhere to standards for commodity storage, injection timing, injection technique, and waste disposal
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Married women aged 18-49 years
- •Decide to use injectable contraception and meet WHO medical eligibility criteria for injectable use
- •Want to avoid pregnancy for at least 12 months
- •Live within study districts
- •Are willing to be contacted by study team members via telephone and/or in-person
排除标准
- •Women under age 18 and above 49
- •Unmarried women
- •Hope to become pregnant within next 12 months
- •Do not reside within study districts
- •Are not willing to be contacted by study team members via telephone or in-person
- •Lack cognitive capacity to give informed consent or complete interviews
结局指标
主要结局
DMPA continuation rate
时间窗: up to 12 months
Participant use of DMPA measured at 3, 6 and 9 months following enrollment (providing coverage for 3 months with each dose)
次要结局
未报告次要终点