Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hyperemesis Gravidarum	Drug: Gabapentin; Drug: Metoclopramide	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Study Start Date :	June 2014
Estimated Primary Completion Date :	September 2017
Estimated Study Completion Date :	May 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: gabapentin; 1800-2400mg/day divided tid or qid, orally.	Drug: Gabapentin; Other Name: Neurontin
Experimental: metoclopramide; 45-60mg/day divided tid or qid, orally	Drug: Metoclopramide; Other Name: Reglan

Outcome Measures

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Primary Outcome Measures :

1. Mean percent change from Baseline to the Study Endpoint in daily Motherisk-PUQE scores (pregnancy-unique quantification of emesis and nausea scale). [ Time Frame: 2 weeks ]
   This study will utilize a flexible study endpoint in order to focus assessments of the outcome measures in the outpatient setting and before any repeat iv fluids are administered since these are the circumstances in which HG patients are most symptomatic. As such, the Study Endpoint will be the mean values from Days 13-14 or, for subjects requiring repeat iv hydration after hospital discharge but before Day 14, the Study Endpoint will be the mean values over the 48 hours prior to this repeat iv hydration administration. Subjects enrolled as outpatients who require repeat iv hydration before study Day 14 will also have a Study Endpoint consisting of the 48 hours prior to the repeat iv hydration administration. Utilizing this flexible Study Endpoint will be an extremely important feature of this study's design since it will avoid including the confounding variables of hospital admission and iv hydration in the data analysis. HG inpatients are typically discharged after 2-5 days.

Secondary Outcome Measures :

1. Mean percent change from Baseline to the Study Endpoint in daily nausea and emesis/retching scores individually from the Motherisk-PUQE and from the raw data. [ Time Frame: 2 weeks ]
2. Mean percent change from Baseline to the Study Endpoint in daily oral nutrition scores. [ Time Frame: 2 weeks ]
3. For subjects enrolled as inpatients, number of days from enrollment to hospital discharge. [ Time Frame: 2 weeks ]
4. Percent of subjects requiring repeat iv hydration or hospital admission for HG from the outpatient setting. [ Time Frame: 2 weeks ]
5. Mean percent change in NVPQOL questionnaire scores from Baseline to the Study Endpoint. [ Time Frame: 2 weeks ]
6. Mean satisfaction and mean relief scores at the Study Endpoint as determined by the Satisfaction Questionnaire. [ Time Frame: 2 weeks ]
7. Percent of subjects downgrading from an answer of 3-5 at Baseline to 1-2 at the Study Endpoint on the Hyperemesis Gravidarum Pregnancy Termination Consideration (HGPTC) questionnaire. [ Time Frame: 2 weeks ]
8. Percent of subjects choosing to continue their experimental therapy at the Study Endpoint as determined by question 3 on the Satisfaction Questionnaire. [ Time Frame: 2 weeks ]
9. Maternal side effects and pregnancy outcomes (maternal complications, term of delivery, mode of delivery, congenital malformations, newborn complications). [ Time Frame: 12 weeks ]
10. Mean percent change in laboratory values and weight from Baseline to Day 14. [ Time Frame: 2 weeks ]
11. Mean percent change from Baseline to Days 26-28 in daily Motherisk-PUQE and NVPQOL scores (during open-label gabapentin treatment). [ Time Frame: 4 weeks ]
12. Mean Satisfaction Questionnaire scores at Day 28. [ Time Frame: 4 weeks ]
13. Percent of subjects downgrading from an answer of 3-5 at Baseline to 1-2 at Day 28 on the HGPTC questionnaire. [ Time Frame: 4 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Contacts

Contact: Thomas Guttuso, Jr., MD	716-829-5454	tguttuso@buffalo.edu
Contact: Loralei L Thornburg, MD	(585) 275-7480	loralei_thornburg@urmc.rochester.edu

Locations

United States, New York
University at Buffalo	Recruiting
Buffalo, New York, United States, 14214
Contact: Rachel LaPorta, RN 716-878-7509 rlaporta@buffalo.edu
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Heather Fiore 585-275-7480 Heather_Fiore@URMC.Rochester.edu

Sponsors and Collaborators

University at Buffalo

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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.

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. Review.

Responsible Party:	Thomas Guttuso, Associate Professor of Neurology, Obstetrics & Gynecology, University at Buffalo
ClinicalTrials.gov Identifier:	NCT02163434 History of Changes
Other Study ID Numbers:	496486-3; 1R01HD076313-01A1 ( U.S. NIH Grant/Contract )
First Posted:	June 13, 2014
Last Update Posted:	August 4, 2015
Last Verified:	August 2015

Keywords provided by Thomas Guttuso, University at Buffalo:

pregnancy; nausea; vomiting; hyperemesis	treatment; gabapentin; metoclopramide; safety

Additional relevant MeSH terms:

Hyperemesis Gravidarum; Morning Sickness; Pregnancy Complications; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Gabapentin; gamma-Aminobutyric Acid; Metoclopramide; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Antiparkinson Agents	Anti-Dyskinesia Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Antimanic Agents; GABA Agents; Antiemetics; Autonomic Agents