At a glance
ClinicalIndex Comparison Record- ✓Pregnant women seeking care at University of Rochester 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
- ✕Already taking antiemetics
- ✕Doxycycline allergy
- ✕Hyperemesis gravidarum
- ✕History of gastroparesis or cyclical vomiting
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial of Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline
In Brief
A clinical study evaluating Ondansetron and Placebo for Drug-induced Nausea and Vomiting. Completed, enrolled 319 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline
placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline