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

• Status: Completed
• Trial end date: 2019-04-03
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rochester
• Treatments: Antiemetics; Doxycycline; Ondansetron

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