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临床试验/NCT00547170
NCT00547170已完成4 期

Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
1,000
试验地点
1
主要终点
Infection

研究概览

简要总结

This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5 days after the abortion. Subjects will be randomized to the standard regimen or to take 200 mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will receive a 7-day course of doxycycline regardless of study group. Subjects will complete questionnaires of symptoms, including nausea and emesis in the recovery room after the procedure and at a single follow-up visit two weeks later. The primary outcome will be infection after abortion, defined below. Analyses will be performed including and excluding Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis, and other side-effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

Half of enrolled women will be randomly assigned to group 1.

干预措施: Doxycycline pre-operatively (Drug)

2

Active Comparator

Half of enrolled women will be randomly assigned to group 2

干预措施: Doxycycline post-operatively (Drug)

结局指标

主要结局

Infection

时间窗: 2 weeks

次要结局

  • nausea and emesis(2 weeks)
  • compliance (completion of study medication)(5 days)

研究者

申办方类型
Other

研究点 (1)

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