Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Phase 2

Completed

Conditions: Hyperemesis Gravidarum

Interventions: Drug: Gabapentin
Drug: Metoclopramide

Registration Number: NCT02163434

Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 31

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gabapentin	Gabapentin	1800-2400mg/day divided tid or qid, orally.
metoclopramide	Metoclopramide	45-60mg/day divided tid or qid, orally

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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