Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Summary

The investigators will compare the effectiveness of gabapentin to metoclopramide for 1 week among 60 women with hyperemesis gravidarum (HG) in this randomized, double-blinded trial. After completion of the 1-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's at Buffalo, of Rochester and of Wisconsin.

Timeline

Start

2014-06

Primary completion

2019-10

Completion

2019-11

Outcome

Met primary endpoint

registry analysis (superiority test); Gabapentin vs Metoclopramide; p = 0.01; Mixed Models Analysis NCT02163434 ↗

paper Gabapentin treatment provided a 52% greater reduction in days 5 to 7 baseline adjusted Motherisk-pregnancy-unique quantification PMID 33451591 ↗

Publications

• Background Guttuso T Jr, Robinson LK, Amankwah KS. Gabapentin use in hyperemesis gravidarum: a pilot study. Early Hum Dev. 2010 Jan;86(1):65-6. doi: 10.1016/j.earlhumdev.2009.11.003. Epub 2009 Dec 16.
• Background Holmes LB, Hernandez-Diaz S. Newer anticonvulsants: lamotrigine, topiramate and gabapentin. Birth Defects Res A Clin Mol Teratol. 2012 Aug;94(8):599-606. doi: 10.1002/bdra.23028. Epub 2012 Jun 22.
• Background Guttuso T Jr. Gabapentin's anti-nausea and anti-emetic effects: a review. Exp Brain Res. 2014 Aug;232(8):2535-9. doi: 10.1007/s00221-014-3905-1. Epub 2014 Mar 26.
• Guttuso T Jr, Messing S, Tu X, Mullin P, Shepherd R, Strittmatter C, Saha S, Thornburg LL. Effect of gabapentin on hyperemesis gravidarum: a double-blind, randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100273. doi: 10.1016/j.ajogmf.2020.100273. Epub 2020 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gabapentin	Unknown	1800 mg	Oral
Subject	Gabapentin	Unknown	2400 mg	Oral
Subject	Metoclopramide	Small molecule	45 mg	Oral
Subject	Metoclopramide	Small molecule	60 mg	Oral

Indications