Clinical trial NCT02163434: Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Official title: Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperemesis Gravidarum
Keywords: pregnancy
nausea
vomiting
hyperemesis
treatment
gabapentin
metoclopramide
safety
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-06-13
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
timeFrame: 1 week
Secondary outcomes:
measure: Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.
timeFrame: 1 week
measure: Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7
timeFrame: 1 week
measure: Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.
timeFrame: 1 week
measure: Global Satisfaction of Treatment at the Study Endpoint.
timeFrame: 1 week
measure: Desire to Continue Therapy at Study Endpoint
timeFrame: 1 week
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
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.
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.
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.
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.