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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
31
University at Buffalo
Buffalo, New York, United States
University of Rochester
Rochester, New York, United States
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.
Time frame: 1 week
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.
Time frame: 1 week
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7
Score range: 0-15 with higher score indicating a better outcome.
Time frame: 1 week
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.
Score range: 0-4 with higher score indicating a better outcome.
Time frame: 1 week
Desire to Continue Therapy at Study Endpoint
Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.
Time frame: 1 week
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