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Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Primary Purpose

Hyperemesis Gravidarum

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Metoclopramide
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperemesis Gravidarum focused on measuring pregnancy, nausea, vomiting, hyperemesis, treatment, gabapentin, metoclopramide, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University at Buffalo
  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

gabapentin

metoclopramide

Arm Description

1800-2400mg/day divided tid or qid, orally.

45-60mg/day divided tid or qid, orally

Outcomes

Primary Outcome Measures

Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
Score range: 6-30 with higher score indicating a worse outcome.

Secondary Outcome Measures

Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.
Score range: 2-10 with higher score indicating a worse outcome.
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7
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.
Global Satisfaction of Treatment at the Study Endpoint.
Score range: 0-4 with higher score indicating a better outcome.
Desire to Continue Therapy at Study Endpoint
Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.

Full Information

First Posted
June 9, 2014
Last Updated
February 10, 2023
Sponsor
State University of New York at Buffalo
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02163434
Brief Title
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Official Title
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperemesis Gravidarum
Keywords
pregnancy, nausea, vomiting, hyperemesis, treatment, gabapentin, metoclopramide, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gabapentin
Arm Type
Experimental
Arm Description
1800-2400mg/day divided tid or qid, orally.
Arm Title
metoclopramide
Arm Type
Experimental
Arm Description
45-60mg/day divided tid or qid, orally
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
Reglan
Primary Outcome Measure Information:
Title
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
Description
Score range: 6-30 with higher score indicating a worse outcome.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.
Description
Score range: 2-10 with higher score indicating a worse outcome.
Time Frame
1 week
Title
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7
Description
Score range: 0-15 with higher score indicating a better outcome.
Time Frame
1 week
Title
Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.
Time Frame
1 week
Title
Global Satisfaction of Treatment at the Study Endpoint.
Description
Score range: 0-4 with higher score indicating a better outcome.
Time Frame
1 week
Title
Desire to Continue Therapy at Study Endpoint
Description
Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.
Time Frame
1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20015600
Citation
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.
Results Reference
background
PubMed Identifier
22730257
Citation
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.
Results Reference
background
PubMed Identifier
24668130
Citation
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.
Results Reference
background
PubMed Identifier
33451591
Citation
Guttuso T Jr, Messing S, Tu X, Mullin P, Shepherd R, Strittmatter C, Saha S, Thornburg LL. Effect of gabapentin on hyperemesis gravidarum: a double-blind, randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100273. doi: 10.1016/j.ajogmf.2020.100273. Epub 2020 Oct 29.
Results Reference
derived

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Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

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