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

NCT02456662 | Completed Results

• 1 other identifier: RSRB00056271
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Symptoms

  Number of participants experiencing symptoms (vomiting or nausea+vomiting) at the time of or after doxycycline

  24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Ondansetron

ACTIVE COMPARATOR

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

Interventions

Ondansetron DRUG

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

Also known as: zofran

Ondansetron

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Lattimore Women's Health Practice

Rochester, New York, 14620, United States

Location

Related Publications (7)

• Sawaya GF, Grady D, Kerlikowske K, Grimes DA. Antibiotics at the time of induced abortion: the case for universal prophylaxis based on a meta-analysis. Obstet Gynecol. 1996 May;87(5 Pt 2):884-90.

  PMID: 8677129 BACKGROUND

• Bryant SG, Fisher S, Kluge RM. Increased frequency of doxycycline side effects. Pharmacotherapy. 1987;7(4):125-9. doi: 10.1002/j.1875-9114.1987.tb04037.x.

  PMID: 3684731 BACKGROUND

• Risser W. Side effects of doxycycline in adolescents treated for pelvic inflammatory disease. J Pediatr Adolesc Gynecol. 2011 Jun;24(3):e87. doi: 10.1016/j.jpag.2011.02.010. No abstract available.

  PMID: 21601804 BACKGROUND

• Reeves MF, Lohr PA, Hayes JL, Harwood BJ, Creinin MD. Doxycycline serum levels at the time of dilation and evacuation with two dosing regimens. Contraception. 2009 Feb;79(2):129-33. doi: 10.1016/j.contraception.2008.09.006. Epub 2008 Nov 13.

  PMID: 19135570 BACKGROUND

• Dean G, Jacobs AR, Goldstein RC, Gevirtz CM, Paul ME. The safety of deep sedation without intubation for abortion in the outpatient setting. J Clin Anesth. 2011 Sep;23(6):437-42. doi: 10.1016/j.jclinane.2011.05.001. Epub 2011 Aug 9.

  PMID: 21831622 BACKGROUND

• Brooks DM, Hand WR Jr. A cost analysis: general endotracheal versus regional versus monitored anesthesia care. Mil Med. 1999 Apr;164(4):303-5.

  PMID: 10226461 BACKGROUND

• ACOG practice bulletin No. 104: antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2009 May;113(5):1180-1189. doi: 10.1097/AOG.0b013e3181a6d011. No abstract available.

  PMID: 19384149 BACKGROUND

MeSH Terms

Conditions

Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Sarah Betstadt, MD, MPH
• Organization: University of Rochester

sarah_betstadt@urmc.rochester.edu

585-276-5367

Study Officials

• Sarah J Betstadt, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: October 7, 2015
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: April 16, 2020
• Results First Posted: April 16, 2020

Record last verified: 2020-04

Locations

US (1)