Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •None not mentioned under Inclusion Criteria.
研究组 & 干预措施
gabapentin
1800-2400mg/day divided tid or qid, orally.
干预措施: Gabapentin (Drug)
metoclopramide
45-60mg/day divided tid or qid, orally
干预措施: Metoclopramide (Drug)
结局指标
主要结局
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
时间窗: 1 week
Score range: 6-30 with higher score indicating a worse outcome.
次要结局
- Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.(1 week)
- Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7(1 week)
- 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)
- Desire to Continue Therapy at Study Endpoint(1 week)
研究者
Thomas Guttuso
Associate Professor of Neurology, Obstetrics & Gynecology
State University of New York at Buffalo