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NCT02456662 · ClinicalTrials.gov registry record · NA
Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial
A NA study, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 319
- Enrollment target
NCT02456662: Completed NA study, sponsored by University of Rochester.
NCT02456662 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 319 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02456662, a NA study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 319 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants experiencing symptoms (vomiting or nausea+vomiting) at the time of or after doxycycline
Interventions
- DRUG Placebo
- DRUG Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2015-10-07 |
| Est. Completion | 2019-04-03 |
| Phase | NA |
What the finished NCT02456662 record still lists
NCT02456662 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02456662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02456662 about?
NCT02456662 is a clinical study titled "Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial". 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 na...
What is the current status of trial NCT02456662?
This trial is currently completed. It is a NA study. The enrollment target is 319 participants. The study started on 2015-10-07. Estimated completion is 2019-04-03.
What interventions are being tested in trial NCT02456662?
The interventions under investigation include: Placebo (DRUG), Ondansetron (DRUG).
Who is sponsoring clinical trial NCT02456662?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02456662's enrollment target sits among peer trials
319 321st of 2000 higher than 1,680 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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