A single-center safety, practicability and acceptance study of _________, a new medical device to support delivering women in their mobilization

Introduction:

„Vibwife One“ is a new mattress that fits on delivery beds. It is designed to support the mobilization of laboring women. „Vibwife One“ has never been tested in a clinical setting. Moreover, the aim of the study was to analyze its safety, practicability and acceptance in a low-risk population.

Methods:

Fifty women with a minimum of 4 cm dilation were recruited. The first five women used the device for 10 minutes, the following 10 women for 20 minutes, and the remaining 35 women for 30 minutes. The women“s vital signs, continuous cardiotocography (CTG), adverse events (AEs) and adverse device effects (ADEs) were recorded during and for 30 minutes post intervention. The women's pain intensity was recorded by a visual analog scale (VAS). Women's experience with the device were evaluated by a Likert scale. The study was approved by the local ethics committee and informed consent was obtained. An independent review board examined all AEs in relation to the study device.

Results:

Women and medical staff overall rated an excellent satisfaction with the product. 46% (n = 23) of women reported that they felt „very relaxed“ and 44% (n = 22) „relaxed“ using the device.

Midwifes judged the device as „very safe“ (n = 33; 77%) and „safe“ (n = 10; 23%). Whether midwifes would recommend the device they replied „I strongly agree“ (n = 13; 30%), „I agree“ (n = 28; 64%), „I disagree“ (n = 1; 2%).

Pain levels before during, and after did not reveal any clear tendencies. However, the rate of women with a PDA at inclusion was as high as 86%.

35 AE occurred in 25 of 50 (50%) women. Types of AEs were distributed as following: 18 (51%) blood pressure modifications (hypo- or hypertension), 8 (23%) CTG abnormalities, 3 (9%) cases of nausea, 2 (6%) episodes of tachycardia, 2 (6%) ADEs, 1 (3%) spontaneous rupture of membranes, and 1 (3%) case of pruritus. Regarding causal relation, 2 (6%) AEs were judged as being certainly related. They were ADEs. Both were short periods of device failure. 25 (71%) AEs were judged as „unlikely“ related or „unrelated“. In 2 (6%) cases the intervention was prematurely stopped. 1 (3%) AE was resolved with sequel (sectio caesarea). However, its relation with the device was categorised as „unlikely“.

Conclusion:

After careful consideration by the safety review board, the use of the medical device „Vibwife One“ was estimated as safe for laboring women and their fetuses. The occurrence of AEs was relatively high, particularly blood pressure changes, but were considered to be primarily related to the progression of labor. A study by Cohen et al. (2015) showed similar findings concerning blood pressure changes during the first stage of labor. Further evaluation should focus on potential benefit in terms of pain management in women without PDA, duration of labor, and mode of delivery.