Does your patient have HG?
Comparison of gabapentin and metoclopramide for treating hyperemesis gravidarum (HG)
Tom Guttuso, MD, University at Buffalo
Loralei Thornburg, MD, University of Rochester Medical Center
Has required at least 1 round of IV fluids.
Has daily emesis for 2 weeks despite trying at least one anti-emetic.
Has 3-4+ketonuria or >5% weight loss from pre-pregnancy weight.
Ultrasound confirmed singleton pregnancy.
Study participants will be randomly assigned to take either gabapentin (Neurontin)* or metoclopramide (Reglan) 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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Rochester Medical Center
Heather Fiore, MS Ed, RD, CDE
University at Buffalo
Rachel LaPorta, MA, BSN, RN
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.
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
Patient Data Form
Patient Data Form Open-Label
University of Rochester Research Subjects Review Board Number RSRB000048512
Clinical Trials.gov Registration Number: NCT02163434