Department of Obstetrics & Gynecology

Does your patient have HG?

Comparison of gabapentin and ondansetron for treating hyperemesis gravidarum (HG)

HGWoman

Principal Investigators:

Tom Guttuso, MD, University at Buffalo
Loralei Thornburg, MD, University of Rochester Medical Center

Eligible Patient:

  1. Has required at least 1 round of IV fluids.
  2. Has daily emesis for 2 weeks despite trying at least one anti-emetic.
  3. Has 3-4+ketonuria or >5% weight loss from pre-pregnancy weight.
  4. Ultrasound confirmed singleton pregnancy.

Study participants will be randomly assigned to take either gabapentin (Neurontin)* or ondansetron (Zofran) without knowing which one they are taking.  

During the two-week study period, women participating in the study will be asked to stop any other treatments for nausea and vomiting, complete a daily form to track symptoms, and complete questionnaires during study visits. 

Participants will have an opportunity to participate in the open-label gabapentin phase of the study for another period of two weeks or longer. 

* Gabapentin is not approved by the FDA to treat HG, but is approved to treat nerve pain and seizures.

Study Sponsor: 

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1R01HD076313-01A1

Study Coordinators:

University of Rochester Medical Center
Heather Fiore, MS Ed, RD, CDE
585-275-9165

University at Buffalo
Rachel LaPorta, MA, BSN, RN
716-878-7315

Treating Clinicians:

If you are seeing a patient enrolled in the study in the emergency room or urgent care, please contact the study coordinator for their enrollment site.   In general, women in this study are asked to stop all other treatment for nausea and vomiting of pregnancy other than IV fluids and their study medications.  Please have them continue to take these as ordered.

Study Forms:

If you are admitted or receive IV fluids after being enrolled in the study you will be asked to fill out three different forms regarding your nausea.  If you lose these forms, extras can be printed from these PDF files.  You will need Adobe Reader open these files, and this can be downloaded for free here

Hyperemesis Gravidarum Pregnancy Termination Consideration (HGPTC) Questionnaire

NVPQOL Questionnaire

Satisfaction Questionnaire

Patient Data Form

Patient Data Form Open-Label

University of Rochester Research Subjects Review Board Number RSRB000048512

Clinical Trials.gov Registration Number: NCT02163434