Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
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ClinicalTrials.gov Identifier: NCT02163434 |
Recruitment Status :
Completed
First Posted : June 13, 2014
Results First Posted : September 27, 2021
Last Update Posted : September 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperemesis Gravidarum | Drug: Gabapentin Drug: Metoclopramide | Phase 2 |
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 |
Actual Primary Completion Date : | October 2019 |
Actual Study Completion Date : | November 2019 |

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 |
- Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7 [ Time Frame: 1 week ]Score range: 6-30 with higher score indicating a worse outcome.
- Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7. [ Time Frame: 1 week ]Score range: 2-10 with higher score indicating a worse outcome.
- Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7 [ Time Frame: 1 week ]Score range: 0-15 with higher score indicating a better outcome.
- Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting. [ Time Frame: 1 week ]
- Global Satisfaction of Treatment at the Study Endpoint. [ Time Frame: 1 week ]Score range: 0-4 with higher score indicating a better outcome.
- Desire to Continue Therapy at Study Endpoint [ Time Frame: 1 week ]Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
None not mentioned under Inclusion Criteria.

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
United States, New York | |
University at Buffalo | |
Buffalo, New York, United States, 14214 | |
University of Rochester | |
Rochester, New York, United States, 14642 |
Documents provided by Thomas Guttuso, University at Buffalo:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Results First Posted: | September 27, 2021 |
Last Update Posted: | September 27, 2021 |
Last Verified: | August 2021 |
pregnancy nausea vomiting hyperemesis |
treatment gabapentin metoclopramide safety |
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 |