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 ]
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