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

NCT03443349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-11-14

No results posted yet for this study

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.

Conditions

  • Medical Device

Interventions

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.

Sponsors & Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Irene Hösli, Prof. Dr. MD · Chief Physician Departement of Obstetrics and Antenatal care

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-23
Primary Completion
2018-11-06
Completion
2018-11-06

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443349 on ClinicalTrials.gov