NCT01596972已完成不适用
The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location: A Pilot Randomized Controlled Trial
Planned Parenthood League of Massachusetts2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Number of Women in Each Group Who Require a Return Visit to the Clinic for a Serum hCG Measurement, Ultrasound or Clinical Examination at One Week to Confirm Complete Evacuation
研究概览
简要总结
The primary aim of this study is to determine if a self-administered semi-quantitative urine pregnancy test and telephone pregnancy symptom questionnaire can reduce the percentage of women with a complete uterine evacuation who require a clinic or lab visit to confirm completion.
The investigators hypothesize that women with complete uterine evacuation will be less likely to require a follow-up clinic or lab visit by using a standardized pregnancy questionnaire and home SQ-UPT, than by using serum hCG as the objective measure of completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Women aged 18 years or older with an undesired pregnancy < 6 weeks gestation
- •Women with a positive urine pregnancy test
- •Proficiency in English
- •Working phone and subject willing to be contacted by phone.
- •Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction with assigned follow-up method
排除标准
- •Women with presence of a yolk sac or crown rump length visualized on ultrasound
- •Women with a gestational sac greater than 13mm [11]
- •High Suspicion for ectopic pregnancy
- •o Sign: Concerning adnexal mass seen on ultrasound in conjunction with pelvic pain and/or vaginal spotting
- •Hemodynamic instability
- •o Signs: heavy vaginal bleeding, hypotension, tachycardia
- •Pelvic Infection
- •o Signs: pain or fever
- •Medical conditions that contraindicate uterine evacuation according to PPLM clinic policy
- •o These include but are not limited to: a bleeding disorder or anticoagulation, significant cardiac disease, renal or liver failure, IUD in situ that cannot be removed
- •Unwilling or unable to comply with study follow-up procedures
- •Being in a situation where receiving phone calls or additional contact with research staff may endanger the privacy or safety of the subject (e.g. situations of domestic violence or abuse)
- •Inability to give informed consent
- •Previous participation in this study
结局指标
主要结局
Number of Women in Each Group Who Require a Return Visit to the Clinic for a Serum hCG Measurement, Ultrasound or Clinical Examination at One Week to Confirm Complete Evacuation
时间窗: 1 week
次要结局
- Patient Compliance With Each Follow-up Method(2 weeks)
- Patient Satisfaction With Each Follow-up Method(1 week)
研究者
研究点 (2)
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