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N/A N=319 Randomized Quadruple-blind Treatment

Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial

Drug-induced Nausea and Vomiting

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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