Clinical Trial: Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Brief Summary: The investigators will compare the effectiveness of gabapentin to metoclopramide for 1-2 weeks among 80 women with hyperemesis gravidarum (HG) in this randomized, double-blinded trial. After completion of the 2-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 at Buffalo and the University of Rochester.

Detailed Summary:
Sponsor: University at Buffalo

Current Primary Outcome: Mean percent change from Baseline to the Study Endpoint in daily Motherisk-PUQE scores (pregnancy-unique quantification of emesis and nausea scale). [ Time Frame: 2 weeks ]

This study will utilize a flexible study endpoint in order to focus assessments of the outcome measures in the outpatient setting and before any repeat iv fluids are administered since these are the circumstances in which HG patients are most symptomatic. As such, the Study Endpoint will be the mean values from Days 13-14 or, for subjects requiring repeat iv hydration after hospital discharge but before Day 14, the Study Endpoint will be the mean values over the 48 hours prior to this repeat iv hydration administration. Subjects enrolled as outpatients who require repeat iv hydration before study Day 14 will also have a Study Endpoint consisting of the 48 hours prior to the repeat iv hydration administration. Utilizing this flexible Study Endpoint will be an extremely important feature of this study's design since it will avoid including the confounding variables of hospital admission and iv hydration in the data analysis. HG inpatients are typically discharged after 2-5 days.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean percent change from Baseline to the Study Endpoint in daily nausea and emesis/retching scores individually from the Motherisk-PUQE and from the raw data. [ Time Frame: 2 weeks ]
  • Mean percent change from Baseline to the Study Endpoint in daily oral nutrition scores. [ Time Frame: 2 weeks ]
  • For subjects enrolled as inpatients, number of days from enrollment to hospital discharge. [ Time Frame: 2 weeks ]
  • Percent of subjects requiring repeat iv hydration or hospital admission for HG from the outpatient setting. [ Time Frame: 2 weeks ]
  • Mean percent change in NVPQOL questionnaire scores from Baseline to the Study Endpoint. [ Time Frame: 2 weeks ]
  • Mean satisfaction and mean relief scores at the Study Endpoint as determined by the Satisfaction Questionnaire. [ Time Frame: 2 weeks ]
  • Percent of subjects downgrading from an answer of 3-5 at Baseline to 1-2 at the Study Endpoint on the Hyperemesis Gravidarum Pregnancy Termination Consideration (HGPTC) questionnaire. [ Time Frame: 2 weeks ]
  • Percent of subjects choosing to continue their experimental therapy at the Study Endpoint as determined by question 3 on the Satisfaction Questionnaire. [ Time Frame: 2 weeks ]
  • Maternal side effects and pregnancy outcomes (maternal complications, term of delivery, mode of delivery, congenital malformations, newborn complications). [ Time Frame: 12 weeks ]
  • Mean percent change in laboratory values and weight from Baseline to Day 14. [ Time Frame: 2 weeks ]
  • Mean percent change from Baseline to Days 26-28 in daily Motherisk-PUQE and NVPQOL scores (during open-label gabapentin treatment). [ Time Frame: 4 weeks ]
  • Mean Satisfaction Questionnaire scores at Day 28. [ Time Frame: 4 weeks ]
  • Percent of subjects downgrading from an answer of 3-5 at Baseline to 1-2 at Day 28 on the HGPTC questionnaire. [ Time Frame: 4 weeks ]


Original Secondary Outcome: Same as current

Information By: University at Buffalo

Dates:
Date Received: June 9, 2014
Date Started: June 2014
Date Completion: May 2018
Last Updated: August 2, 2015
Last Verified: August 2015