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Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163434
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Thomas Guttuso, University at Buffalo

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

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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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: 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163434


Locations
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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)
Publications:
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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    Key Record Dates
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:
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Hyperemesis Gravidarum
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive
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