Phase 2
N=31
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Hyperemesis Gravidarum
Bottom Line
View on ClinicalTrials.gov: NCT02163434 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7 — 6.35; 13.22 units on a scale — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gabapentin (Drug); Metoclopramide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7 |
6.35; 13.22 | 0.01 sig |
| SECONDARY Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7. |
2.01; 3.69 | 0.005 sig |
| SECONDARY Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7 |
7.86; 4.01 | 0.01 sig |
| SECONDARY Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting. |
5; 5 | — |
| SECONDARY Global Satisfaction of Treatment at the Study Endpoint. |
2.22; 0.63 | 0.03 sig |
| SECONDARY Desire to Continue Therapy at Study Endpoint |
0.67; 0.14 | 0.06 |
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.
Eligibility Criteria
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 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 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.
Data sourced from ClinicalTrials.gov (NCT02163434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.