Trial · NCT02163434

Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

NCT02163434, Phase 2, Completed, State University of New York at Buffalo; results first posted 2021-09-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum. Trials, record NCT02163434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02163434

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
NCT number: NCT02163434
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: State University of New York at Buffalo
Conditions: Hyperemesis Gravidarum
Interventions: Gabapentin, Metoclopramide
First posted: 2014-06-13
Last updated: 2023-02-14
Results first posted: 2021-09-27

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7	1 week	units on a scale	MEAN
SECONDARY	Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.	1 week	units on a scale	MEAN
SECONDARY	Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7	1 week	units on a scale	MEAN
SECONDARY	Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.	1 week	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Global Satisfaction of Treatment at the Study Endpoint.	1 week	units on a scale	MEAN
SECONDARY	Desire to Continue Therapy at Study Endpoint	1 week	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7	Gabapentin	6.35	Standard Error 2.44	units on a scale
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7	Metoclopramide	13.22	Standard Error 2.39	units on a scale
Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.	Gabapentin	2.01	Standard Error 0.45	units on a scale
Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.	Metoclopramide	3.69	Standard Error 0.45	units on a scale
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7	Gabapentin	7.86	Standard Error 1.23	units on a scale
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7	Metoclopramide	4.01	Standard Error 1.34	units on a scale
Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.	Gabapentin	5		Participants
Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.	Metoclopramide	5		Participants
Global Satisfaction of Treatment at the Study Endpoint.	Gabapentin	2.22	Standard Error 1.56	units on a scale
Global Satisfaction of Treatment at the Study Endpoint.	Metoclopramide	0.63	Standard Error 0.74	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gabapentin	15
Overall Study	STARTED	Metoclopramide	16
Overall Study	COMPLETED	Gabapentin	12
Overall Study	COMPLETED	Metoclopramide	9
Overall Study	NOT COMPLETED	Gabapentin	3
Overall Study	NOT COMPLETED	Metoclopramide	7

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Tachycardia	Cardiac disorders	Gabapentin	1	15	1
other	Tachycardia	Cardiac disorders	Metoclopramide	0	16	0
other	Hot Flashes	Endocrine disorders	Gabapentin	1	15	1
other	Hot Flashes	Endocrine disorders	Metoclopramide	0	16	0
other	fatigue	General disorders	Gabapentin	2	15	2
other	fatigue	General disorders	Metoclopramide	0	16	0
other	Dizziness	Nervous system disorders	Gabapentin	1	15	1
other	Dizziness	Nervous system disorders	Metoclopramide	1	16	1
other	Headache	Nervous system disorders	Gabapentin	0	15	0
other	Headache	Nervous system disorders	Metoclopramide	1	16	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gabapentin	0	12
Total, all-cause mortality	Metoclopramide	0	9
Total, other adverse events	Gabapentin	4	15
Total, other adverse events	Metoclopramide	3	16
Total, serious adverse events	Gabapentin	0	12
Total, serious adverse events	Metoclopramide	0	9

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20015600	BACKGROUND	PubMed
22730257	BACKGROUND	PubMed
24668130	BACKGROUND	PubMed
33451591	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD076313	Comparison of gabapentin and ondansetron for treating hyperemesis gravidarum	GUTTUSO, THOMAS J	STATE UNIVERSITY OF NEW YORK AT BUFFALO	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2014 to 2017

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gabapentin vs Metoclopramide: Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.	Trial comparisons
Gabapentin vs Metoclopramide: deaths from any cause	Trial comparisons
Gabapentin vs Metoclopramide: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02163434

GET https://conductscience.org/api/trials/v1/NCT02163434/registered

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