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

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ClinicalTrials.gov Identifier: NCT02456662
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah Betstadt, University of Rochester

Brief 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.


Condition or disease Intervention/treatment Phase
Drug-induced Nausea and Vomiting Drug: Ondansetron Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline
Drug: Placebo
placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline

Active Comparator: Ondansetron
160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline
Drug: Ondansetron
8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline
Other Name: zofran




Primary Outcome Measures :
  1. Nausea and vomiting after doxycycline use [ Time Frame: maximum 24 hours ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456662


Contacts
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Contact: Sarah J Betstadt, MD, MPH 585-276-5368 sarah_Betstadt@urmc.rochester.edu
Contact: Keelin Abbott keelin_abbott@urmc.rochester.edu

Locations
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United States, New York
Lattimore Women's Health Practice Recruiting
Rochester, New York, United States, 14620
Contact: Keelin Abbott    585-275-2691    keelin_abbott@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Sarah J Betstadt, MD, MPH University of Rochester

Publications:
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Responsible Party: Sarah Betstadt, MD, MPH, University of Rochester
ClinicalTrials.gov Identifier: NCT02456662     History of Changes
Other Study ID Numbers: RSRB00056271
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Antiemetics
Doxycycline
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents