A Randomized Controlled Trial of Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline
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
- 是
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
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
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
Sarah Betstadt
MD, MPH
University of Rochester
