Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

February 10, 2023 updated by: Thomas Guttuso, State University of New York at Buffalo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • University at Buffalo
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: gabapentin
1800-2400mg/day divided tid or qid, orally.
Drug: Gabapentin
Other Names:
  • Neurontin
EXPERIMENTAL: metoclopramide
45-60mg/day divided tid or qid, orally
Drug: Metoclopramide
Other Names:
  • Reglan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week
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.
1 week
Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.
Time Frame: 1 week
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.
1 week
Desire to Continue Therapy at Study Endpoint
Time Frame: 1 week
Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (ESTIMATE)

June 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 496486-3
  • 1R01HD076313-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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