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临床试验/NCT02581761
NCT02581761Unknown不适用

A Randomized Prospective Double Blind Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location

Sheba Medical Center0 个研究点目标入组 100 人开始时间: 2015年11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
入组人数
100
主要终点
The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (<2 IU/l) by the initial intervention strategy

研究概览

简要总结

A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.

详细描述

A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.

The management of asymptomatic patients with pregnancies of unknown location (PUL) remains a challenge. Determining the location of the pregnancy is the first priority in the evaluation of these women. Some of these asymptomatic women present with inappropriate raising beta-human chorionic gonadotropin (βHCG), while others have assurance of pregnancy duration (e.g. IVF pregnancies) with no sonographic evidence of intra or extra uterine pregnancy. Most of the PULs are failed intra-uterine pregnancies.

The main concern regarding PUL is the late diagnosis of an ectopic pregnancy (EP). Some studies report that between 5 and 42% of women seen for US assessment with a positive pregnancy test have a PUL and only 6-20% will subsequently diagnosed with EP (1). Other studies report that 94% of PUL will resolve spontaneously, and out of the 6% that did not spontaneously resolve 68.9 % were finally diagnosed with failed IUP and only 5.6% were diagnosed with EP (2).

Women with PUL should be evaluated in minimum time, but also with minimal invasiveness. Management that will resolve such pregnancies in a rapid manner will save time and money and possibly avoid unnecessary administration of MTX or surgical intervention.

Several protocols have been investigated in order to fasten the diagnosis of PUL. For example, obtaining serial β-HCG, the first one in the initial presentation, two days later and seven days later (3). Another protocol suggested endometrial sampling by D&C or aspiration of uterine continents with Karman cannula and checking the β-HCG after 24 hours (2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • hemodynamically stable women >18 years old with a PUL with abnormal plateauing serum βHCG trend

排除标准

  • Hemoglobin<10

研究组 & 干预措施

Cytotec treatment group

Experimental

patient with pregnancy of unkown location will receive cytotec 800 mcg per vaginal

干预措施: CYTOTEC (Drug)

Placebo treatment group

Placebo Comparator

patient with pregnancy of unkown location will receive suppository which contain Whitepsol H-15 with no active material (Cytotec).

干预措施: Placebo (Other)

结局指标

主要结局

The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (<2 IU/l) by the initial intervention strategy

时间窗: two weeks for each patient

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Isa Amal

DR

Sheba Medical Center

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