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Completed

NCT Number: NCT02163434

Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University at Buffalo, Buffalo, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

Other names: Neurontin

Metoclopramide

Drug

Other names: Reglan

Primary outcomes

  1. Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7

    Time frame: 1 week

    Score range: 6-30 with higher score indicating a worse outcome.

Secondary outcomes

  1. Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.

    Time frame: 1 week

    Score range: 2-10 with higher score indicating a worse outcome.

  2. Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7

    Time frame: 1 week

    Score range: 0-15 with higher score indicating a better outcome.

  3. Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.

    Time frame: 1 week

  4. Global Satisfaction of Treatment at the Study Endpoint.

    Time frame: 1 week

    Score range: 0-4 with higher score indicating a better outcome.

  5. Desire to Continue Therapy at Study Endpoint

    Time frame: 1 week

    Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2014
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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