Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2014
End Date:May 2018
Contact:Thomas Guttuso, Jr., MD
Email:tguttuso@buffalo.edu
Phone:716-829-5454

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The investigators will compare the effectiveness of gabapentin to metoclopramide for 1-2
weeks among 80 women with hyperemesis gravidarum (HG) in this randomized, double-blinded
trial. After completion of the 2-week double-blind phase, subjects will be offered
open-label gabapentin with rescue metoclopramide until their symptoms no longer require
treatment. Enrollment will occur at the University at Buffalo and the University of
Rochester.


Inclusion Criteria:

1. Have received at least 2 administrations of intravenous (iv) hydration separated by
at least 1 week or daily emesis for at least the last 14 days and 1 administration of
iv hydration.

2. Have at least one of the following: 3-4+ ketonuria, serum potassium < 3.4mmol, or >5%
weight loss from weight upon entry to prenatal care.

3. Have failed therapy with at least one antiemetic.

4. Have fetal ultrasound within 6 weeks prior to enrollment confirming a
normal-appearing, intrauterine, singleton pregnancy of gestational age < 16 weeks at
time of enrollment.

5. Felt by the patient's obstetrician or emergency room attending physician not to have
other medical problems such as bowel obstruction, pancreatitis, biliary colic, or
peptic ulcer disease that could be contributing to the patient's symptoms.

6. Be >18 years old and not decided to terminate the pregnancy.

7. Have not received or planning to receive a peripherally inserted central catheter
(PIC line).

8. Have a Motherisk-PUQE score of ≥12 for the 24-hour Baseline period.

9. Felt not to have any other significant medical, psychiatric or substance abuse
problem that would preclude participation in the study.

10. Denies drinking any alcohol after learning about current pregnancy.

11. Agrees to discontinue any current anti-emetic treatments (including antihistamines,
ginger, > 10mg/day vitamin B6, serotonin or dopamine antagonists, anticholinergics,
acupuncture, hypnosis, or wrist bands) for the next 4 weeks.

12. Pregnancy not conceived through in-vitro fertilization.

13. Able to understand and comply with the study procedures and give informed consent.

Exclusion Criteria:

None not mentioned under Inclusion Criteria.
We found this trial at
2
sites
Buffalo, New York 14215
Phone: 716-878-7509
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Phone: 585-275-7480
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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