Safety and acceptance of "Vibwife", a new moving mattress to support mobilization during labor: Result of a clinical study.

Objective: To examine the safety and acceptance "Vibwife", a new moving mattress to support mobilization of pregnant women during labor.

Design: The study was a prospective medical device clinical study without a control group. The study was designed in intervention phases, with safety evaluation by a safety review board after each intervention phase.

Setting: The study took place at the University Hospital of Basel, Switzerland.

Participants: 50 women were included with a low risk singleton pregnancy > 37 weeks during the first stage of labor.

Intervention: Evaluation of the safety and acceptance of women, midwives and physicians during the first stage of labor. The intervention was carried out in 3 phases. In the first phase five women in labor used the device for 10 minutes, the next 10 women for 20 minutes, and finally the next 35 women for 30 minutes.

Measurements: Measurement included capturing Adverse Events (AEs) (including Adverse Device Effects (ADEs)), Serious Adverse Events (SAEs) and recording vital parameters before, during, and after intervention, as well as CTG before and after intervention. Acceptance by women, midwives and physicians was measured by questionnaires with a 4-point Likert scale and pain intensity by a discrete Visual Analogue Scale (VAS) from 0-10.

Findings: No SAE occurred during the trial. A total of 32 AEs occurred in 25 women during the intervention or in the 30 minutes follow-up. The most frequently observed AEs were modification of blood pressure and CTG abnormalities. None of the 32 AEs led to sequels of any kind. The relationship between AEs occurrence and the use of the medical device was viewed as certain in 2 cases (6.2%), possible or likely in 8 cases (25%), and unlikely or unrelated in 22 cases (68, 7%). Overall, women, midwives and physicians reported high satisfaction with their use of the device.

Key Conclusions And Implications For Practice: The medical device "Vibwife" was judged as safe for women. Acceptance among women and health personnel was good. Considering the potential benefits of mobilization during labor, this new medical device could be a very interesting adjunct to other obstetrical tools. Particularly, women whose mobility is restrained by epidural anesthesia while giving birth could be very suitable candidates. To answer the question of efficacy, a randomized-controlled trial is required.