Effect of gabapentin on hyperemesis gravidarum: a double-blind, randomized controlled trial

Background Hyperemesis gravidarum is a disabling disease of nausea, vomiting, and undernutrition in early pregnancy for which there are no effective outpatient therapies. Poor weight gain hyperemesis associated with several adverse fetal outcomes including preterm delivery, low birthweight, small gestational age, 5-minute Apgar scores, neurodevelopmental delay. Gabapentin most commonly used clinically treating neuropathic pain but also substantially reduces chemotherapy-induced postoperative nausea vomiting. Pregnancy registry data have shown maternal first-trimester gabapentin monotherapy to be 1.2% rate major congenital malformations among 659 infants, compares favorably the 1.6% 2.2% malformation general population. Open-label treatment was reduced vomiting improved oral nutrition. Objective This study aimed determine whether more than standard-of-care therapy gravidarum. Study Design A double-blind, randomized, multicenter trial conducted patients medically refractory requiring intravenous hydration. Patients were randomized (1:1) either (1800–2400 mg/d) or an active comparator ondansetron (24–32 metoclopramide (45–60 7 days. Differences Motherisk–pregnancy-unique quantification emesis total scores between groups averaged over days 5 7, using intention-to-treat principle employing linear mixed-effects model adjusted baseline served as primary endpoint. Secondary included vomit retch subscores, nutrition, global satisfaction treatment, relief, desire continue therapy, Nausea Vomiting Quality Life, Gravidarum Termination Consideration. Adjustments multiple comparisons made false discovery rate. Results 31 enrolled from October 2014 May 2019. Among 21 providing outcome (12 assigned 9 arm), 18 outpatients all 7. The groups’ characteristics well matched. provided 52% greater reduction (95% confidence interval, 16–88; P=.01). Most secondary favored 46% 49% decreases 19–72; P=.005) subscores 21–77; P=.005), respectively; 96% increase nutrition 27–165; P=.01); 254% difference 48–459; P=.03). Relief (P=.06) both showed trends favoring Life (P=.68) Consideration (P=.58) did not. Adverse events roughly equivalent groups. There serious events. Conclusion In this trial, reducing increasing These build on previous findings other patient populations supporting novel antinausea antiemetic support further research challenging complication pregnancy.