N/A
N=319
Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial
Drug-induced Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT02456662 ↗Enrolled (actual)
319
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants Experiencing Symptoms — 45; 19 Participants — p=0.00
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ondansetron (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Symptoms |
45; 19 | 0.00 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02456662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.