Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Accuracy of these two types of home pregnancy tests
研究概览
简要总结
This randomized study will examine the effectiveness of two types of pregnancy tests (a semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home at various time points after early medical abortion. The first test a semi-quantitative panel test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This urine-based, one-step kit has been used in two previous studies in Vietnam (12, 13). The second test is a locally available urine dipstick (Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA).
- The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14.
- The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7.
- The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age ≤63days from LMP
- •Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines(national guidelines stipulate that women can receive medical abortion thru 63 days LMP at Hung Vuong (tertiary level) hospital; women with gestations up to 49 days LMP can receive medical abortion at Hocmon (district) hospital)
- •Willing to follow instructions of the provider regarding use of the pregnancy tests
- •Able to read and write to use pregnancy test at home
- •Willing to be randomized to perform one of two types of urine pregnancy tests at three time points at home
- •Willing to provide an address and/or telephone number for purposes of follow-up
- •Agrees to return for follow-up visit at clinic to confirm abortion status
- •Wishes to participate in the study
- •Able to consent to study participation
排除标准
- •Women not meeting the above inclusion criteria
结局指标
主要结局
Accuracy of these two types of home pregnancy tests
时间窗: 2 weeks
Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration.
次要结局
- Comparison of the two types of pregnancy tests at identifying continuing pregnancy(2 weeks)
- The use and acceptability of the two tests(2 weeks)
- Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider(2 weeks)