CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 319 enrolled
Drug / intervention
Ondansetron +1 moredrug
Likely dose
Ondansetron 8 mg orally 30 minutes prior to doxycycline 200 mg orallyAI-extracted
Key inclusion· 4
  • 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
Key exclusion· 5
  • 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.

Search/NCT02456662
NCT02456662N/ACompleted

A Randomized Controlled Trial of Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline

University of Rochester·interventional·Posted May 28, 2015·Updated Apr 16, 2020

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 28, 2015
Enrollment StartOct 7, 2015
Primary CompletionApr 3, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.1 years ago

Interventions

Ondansetrondrug

8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline

Placebodrug

placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline