Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial
Status:
Completed
Trial end date:
2019-04-03
Target enrollment:
Participant gender:
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.