Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Hyperemesis Gravidarum Clinical Trial

Official title:

Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163434
• Other study ID #: 496486-3
• Secondary ID: 1R01HD076313-01A
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: November 2019

Study information

• Verified date: February 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperemesis Gravidarum

Intervention

Drug:
• Gabapentin

• Metoclopramide

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7	Score range: 6-30 with higher score indicating a worse outcome.	1 week
Secondary	Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.	Score range: 2-10 with higher score indicating a worse outcome.	1 week
Secondary	Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7	Score range: 0-15 with higher score indicating a better outcome.	1 week
Secondary	Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.		1 week
Secondary	Global Satisfaction of Treatment at the Study Endpoint.	Score range: 0-4 with higher score indicating a better outcome.	1 week
Secondary	Desire to Continue Therapy at Study Endpoint	Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.	1 week