NCT02179944已完成不适用
Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion: A Prospective Physiologic Study
Planned Parenthood League of Massachusetts1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2014年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Percent serum hCG decline from Day 1 to Day 3, from Day 1 to Day 5, and from Day 1 to Day 7-10
研究概览
简要总结
This project will be a prospective physiologic study. We will closely follow 60 medication abortion patients with serial repeat serum hCG and urine semi-quantitative hCG testing. We plan to recruit patients from two gestational age strata: ≤ 49 days and > 49 days.
Study Objectives:
- To create a nomogram describing the change in serum hCG values in the first five days immediately following medication abortion with mifepristone and misoprostol. Specifically, we will describe the percent serum hCG decline from Day 1 (day of mifepristone) to Day 3 (day after misoprostol), from Day 1 to Day 5, and from Day 1 to Day 7-10.
- To explore whether there is a significant difference in the rate of hCG decline based on initial gestational age determined by ultrasound and initial serum hCG.
- To describe the correlation between semi-quantitative urine hCG test results and serum hCG values to determine how soon after initiating medication abortion the urine test can detect completed abortion.
We hypothesize that among successful medication abortions, there will be a predictable trend with at least a 50% drop by Day 3 and 80% drop by Day 5.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Desire for medication abortion for pregnancy termination AND
- •Pregnancy confirmed by ultrasound and gestational age ≤ 63 days based on transvaginal ultrasound (TVUS) OR
- •Positive high-sensitivity urine hCG and intrauterine pregnancy (IUP) not confirmed on TVUS
排除标准
- •Ineligibility for medication abortion at Planned Parenthood League of Massachusetts (PPLM) based on current PPLM clinical guidelines
- •Initiation of medication abortion on Wednesday or Friday
- •Failed pregnancy defined as:
- •Crown-rump length ≥ 7mm and no heartbeat
- •Mean sac diameter ≥ 25mm and no embryo
- •Reasonable clinical suspicion for ectopic or molar pregnancy such as abnormal or concerning ultrasound findings
- •Multiple gestation
- •Age less than 18 years
- •Prior participation in this study
- •Anticipated inability to present for scheduled follow-up visits
结局指标
主要结局
Percent serum hCG decline from Day 1 to Day 3, from Day 1 to Day 5, and from Day 1 to Day 7-10
时间窗: 10 days from misoprostol administration
blood sample collection for hCG testing on Day 3, Day 5 and Day 7-10 (Day 1 is day of mifepristone administration)
次要结局
- difference in rate of hCG decline based on initial gestational age(10 days after misoprostol administration)
研究者
研究点 (1)
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