NCT03443349

"Vibwife One" a New Medical Device to Support Delivering Women in Their Mobilization

A Single - Centre Safety Study About the Safety, Practicability and Acceptance of "Vibwife One", a New Medical Device to Support Delivering Women in Their Mobilization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

"Vibwife One" was developed to support the mobilization of the delivering women during the labor process. It consists of a mattress that fits on existing delivery beds. Different movements, adjustable in pace and intensity can be chosen to mobilize women in labor. Although existing evidence is rare, some literature and historical reports have shown a positive impact of active mobilization during labor. At time of rising epidural anesthesia rate, "Vibwife One" could be an interesting way to active mobilize those women to support the physiological birth process. So far, the device has not yet been applied in delivering women. The investigators carry out a first safety study to assess the safety, to evaluate the comfort and the practicability for delivering women and medical staff of this new medical device.

Detailed description

The medical device will be used according to its market authorization. Because it will be used for the first time in pregnant women, the following three step application procedure has been determined: * First five pregnant women use the device for 10 minutes. Each of them in a position and module proposed by the midwife with the agreement of the woman. * Next 10 pregnant women use the device for 20 minutes. Again, position and module according to the decision of the midwife with the agreement of the woman. * All the remaining pregnant women (35) use the device for 30 minutes. Position and module according to the decision of the midwife with the agreement of the woman. During the intervention period, position and module might be changed once if required. After the inclusion of all the 50 participants, each position and module has to be tested. There will be a safety review board consisting of one physician, one midwife and a clinical expert midwife meeting after each group of pregnant women having used the device, evaluating the safety criteria according to predefined Adverse Device Effects and Adverse Events.

Conditions

• Medical Device

Interventions

Type	Name	Description
DEVICE	Vibwife One	Vibwife One is a powered rotation bed intended to be used to assist in active mobilization of delivering women. "Vibwife One" imitates manual mobilization and position techniques. It is integrated in the mattress and fixed to the pelvis area of the birthing bed. "Vibwife One" can be used, when manual mobilization and position techniques are deemed appropriate. The device with all its functions is controlled over a remote control.

Timeline

• Start date: 2018-01-23
• Primary completion: 2018-11-06
• Completion: 2018-11-06
• First posted: 2018-02-23
• Last updated: 2018-11-14

Locations

1 site across 1 country: Switzerland