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临床试验/NCT02456662
NCT02456662已完成不适用

A Randomized Controlled Trial of Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline

University of Rochester1 个研究点 分布在 1 个国家目标入组 319 人开始时间: 2015年10月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
319
试验地点
1
主要终点
Number of Participants Experiencing Symptoms

研究概览

简要总结

Background/Purpose of the Study Doxycycline is an antibiotic used for infection prevention before surgical pregnancy termination, and a side effect of it is nausea/vomiting. The investigators' study explores whether or not taking the anti-emetic ondansetron prior to doxycycline decreases rates of nausea/vomiting. Patients enrolled in the investigators' study will take either ondansetron or a placebo before they take doxycycline to see if ondansetron decreases their nausea/vomiting. Reducing nausea/vomiting may prevent more infections, and decrease the rates of general anesthesia, patient risks and hospital costs. Decreasing nausea/vomiting will also improve patient experience.

Study Design This will be a randomized controlled trial. Data will be collected by administrating surveys and a log where patients will record the timing of their medications and episodes of nausea/vomiting. The primary outcome is nausea/vomiting after taking the anti-emetic/placebo and doxycycline. 400 eligible patients will be enrolled over two years, 200 in the intervention group and 200 in the placebo group.

Rationale for Study Design A randomized controlled trial will be used to determine the effects of the anti-emetic ondansetron on rates of nausea/vomiting.

Subject Characteristics Patients will be pregnant females, 18-45 years old, who are undergoing surgical termination of pregnancy.

Design 1-2 days before the procedure, patients will complete a demographic questionnaire and a survey about symptoms of nausea/vomiting. They will use a log to record symptoms they experience between taking the anti-emetic/placebo and when they present for their procedure. When patients come to the hospital, they will fill out a repeat survey rating their nausea/vomiting.

详细描述

Scheduled Prophylactic Anti-emetics for Reduction of Emesis with Doxycycline (SPARED) Trial - Study Protocol

Principal Investigator:

Sarah Betstadt, MD MPH Department of Obstetrics & Gynecology University of Rochester Medical Center 601 Elmwood Avenue Rochester, NY 14642-8668 Phone: (585) 276-5367

Co-Investigators:

Amy Harrington, MD

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women seeking care at the University of Rochester's Women's Health Practice Family Planning Clinic
  • Undergoing second trimester surgical termination of pregnancy
  • Proficient in reading, writing, and comprehending English
  • Able to give informed consent

排除标准

  • Not proficient in reading, writing, or comprehending English
  • Not able to give informed consent
  • Already taking antiemetics
  • Doxycycline allergy
  • Hyperemesis gravidarum
  • History of gastroparesis or cyclical vomiting
  • Unable to swallow pills

研究组 & 干预措施

Placebo

Placebo Comparator

160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline

干预措施: Placebo (Drug)

Ondansetron

Active Comparator

160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline

干预措施: Ondansetron (Drug)

结局指标

主要结局

Number of Participants Experiencing Symptoms

时间窗: 24 hours

Number of participants experiencing symptoms (vomiting or nausea+vomiting) at the time of or after doxycycline

次要结局

未报告次要终点

研究者

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

Sarah Betstadt

MD, MPH

University of Rochester

研究点 (1)

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