Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
2 other identifiers
interventional
31
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2014
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedResults Posted
Study results publicly available
September 27, 2021
CompletedFebruary 14, 2023
February 1, 2023
5.3 years
June 9, 2014
December 7, 2020
February 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
Score range: 6-30 with higher score indicating a worse outcome.
1 week
Secondary Outcomes (5)
Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.
1 week
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7
1 week
Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.
1 week
Global Satisfaction of Treatment at the Study Endpoint.
1 week
Desire to Continue Therapy at Study Endpoint
1 week
Study Arms (2)
gabapentin
EXPERIMENTAL1800-2400mg/day divided tid or qid, orally.
metoclopramide
EXPERIMENTAL45-60mg/day divided tid or qid, orally
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Have at least one of the following: 2-4+ ketonuria, serum potassium \< 3.4mmol, or \>5% weight loss from weight upon entry to prenatal care.
- Have failed therapy with at least one antiemetic.
- 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.
- 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.
- Be \>18 years old and not decided to terminate the pregnancy.
- Have not received or planning to receive a peripherally inserted central catheter (PIC line).
- Have a Motherisk-PUQE score of ≥12 for the 24-hour Baseline period.
- Felt not to have any other significant medical, psychiatric or substance abuse problem that would preclude participation in the study.
- Denies drinking any alcohol after learning about current pregnancy.
- 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.
- Pregnancy not conceived through in-vitro fertilization.
- Able to understand and comply with the study procedures and give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University at Buffalo
Buffalo, New York, 14214, United States
University of Rochester
Rochester, New York, 14642, United States
Related Publications (4)
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.
PMID: 20015600BACKGROUNDHolmes 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.
PMID: 22730257BACKGROUNDGuttuso 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.
PMID: 24668130BACKGROUNDGuttuso 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.
PMID: 33451591DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Thomas Guttuso, Jr.
- Organization
- University at Buffalo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology, Obstetrics & Gynecology
Study Record Dates
First Submitted
June 9, 2014
First Posted
June 13, 2014
Study Start
June 1, 2014
Primary Completion
October 1, 2019
Study Completion
November 1, 2019
Last Updated
February 14, 2023
Results First Posted
September 27, 2021
Record last verified: 2023-02