Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

• ClinicalTrials.gov Identifier: NCT02163434
• Recruitment Status: Active, not recruiting
• First Posted: June 13, 2014
• Last Update Posted: October 24, 2019
• Sponsor: University at Buffalo
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Thomas Guttuso, University at Buffalo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperemesis Gravidarum	Drug: Gabapentin; Drug: Metoclopramide	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 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: October 2019
• Estimated Study Completion Date: November 2019

Arms and Interventions

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

Primary Outcome Measures :

1. Mean percent change from Baseline to Days 5-7 in daily Motherisk-PUQE scores (pregnancy-unique quantification of emesis and nausea scale). [ Time Frame: 1 week ]

Secondary Outcome Measures :

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

Eligibility Criteria

• 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: 2-4+ 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

Locations

United States, New York

University at Buffalo

Buffalo, New York, United States, 14214

University of Rochester

Rochester, New York, United States, 14642

Sponsors and Collaborators

University at Buffalo

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

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
• Other Study ID Numbers: 496486-3; 1R01HD076313-01A1 ( U.S. NIH Grant/Contract )
• First Posted: June 13, 2014
• Last Update Posted: October 24, 2019
• Last Verified: October 2019

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; Metoclopramide; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimanic Agents; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents