ABSTRACT
INTRODUCTION: The aim of this study was to pilot Relaxbirth® (Relaxbirth®, Ltd., Helsinki, Finland), an investigational device designed to facilitate upright positioning intrapartum. The objective was to 1) compare birth outcomes with and without the use of Relaxbirth®, and 2) assess device usability. METHODS AND MATERIALS: Study design: prospective product use and retrospective case control study at one perinatal center in Ohio. INCLUSION CRITERIA: ≥18 years old, <300 lbs. women with a low-risk, term gestation of a singleton, vertex fetus, and vaginal birth between January 2013 to June 2016. Participants who used the Relaxbirth® device intrapartum (RB group) were retrospectively case-matched to controls (CON group) according to age, race, insurance, gravida/parity, gestational age and labor type. Birth outcomes (primary outcome) were compared between groups. Providers and women who used Relaxbirth® assessed usability of the device with the Modified System Usability Scale Tool (secondary outcome). RESULTS: Of the n = 60 included in the final analysis, RB women (n = 30) pushed for a shorter average duration compared to CON women (n = 30) [34 min (±48) versus 60 min (±63), p = 0.023]. RB women did not experience more adverse birth outcomes including: longer second stage duration, operative vaginal delivery, malpresentation, perineal laceration/episiotomy, higher blood loss, or low Apgars. Usability survey results were favorable (Total Average Scores: providers 74.1; RB 83.6). CONCLUSION: Clinical experience with the Relaxbirth® device was positive at this pilot site. The device was associated with favorable birth outcomes and usability, suggesting potential as a safe and novel adjunct to promote intrapartum choices, upright positioning and maternal satisfaction.
