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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Medical Device

Intervention / Treatment
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* Device: Vibwife One


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent documented by signature German or English speaking Singleton healthy pregnancy Cephalic presentation ≥37th weeks of gestation 4cm - 9cm of dilatation Regular contractions Physiological cardiotocograph (CTG) 30 min pre-intervention Physiological blood pressure (111/66 - 139/89) Exclusion Criteria: Multiple pregnancies Breech position Small for gestational age (<10. Percentile) Fetal congenital abnormalities Placenta praevia Fetal distress Heavy vaginal bleeding during birth Maternal weight ≥ 135 kg Preeclampsia or HELLP Diabetes I and II / Gestational diabetes insulin dependent Spinal and back disorder (herniated disk / scoliosis) Hypertension (≥140/90 mmHg) Hypotension (Basic blood pressure in the third trimester -20%, if not available: ≤ 110/65 mmHg) No signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The medical device will be used according to its market authorization, i.e. CE-Certification. Because it will be used for the first time in pregnant women, a vulnerable population, 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 in agreement with the woman. All the remaining pregnant women (35) use the device for 30 minutes. Position and module proposed by the midwife with the agreement of the woman. During the intervention period, position and module might be changed once if required. There will be a safety review board meeting after each group of the pregnant women having used the device, checking the safety criteria according to predefined Adverse Device Effects and Adverse Events.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Use of the medical Device: Vibwife One<br>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. | Device: Vibwife One<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by number of Adverse Events and Adverse Device Effects | The Primary outcome is safety of the pregnant woman and the child using Vibwife One in the first stage of Labor. It will be evaluated according to predefined Adverse Events and Adverse Device Effects. | During intervention and until 30min. after end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity is measured by a discrete Visual Analogue Scale (VAS) from 0-10, 0 indicating no pain until 10 indicating greatest pain | VAS before, during and after end of the intervention, intervention lasting up to 30 min. | 
| Preferences measured by questionnaire | Women's preferences regarding the medical device will be measured by a questionnaire with a 4-issue Likert scale; Likert scaling is a bipolar scaling method, measuring either positive or negative response to a statement. The responses in this study might be 1.Strongly disagree, 2.Disagree, 3.Agree 4. Strongly agree, answers ranging from 1 point (strongly disagree) to 4 points (strongly agree). Low amount of points represent a better outcome. | within 30 minutes after end of the intervention, intervention lasting up to 30 min. | 
| Practicability measured by questionnaire | Practicability of the medical device and views of the midwives and physicians will be assessed by a questionnaire with a 4-issue Likert scale; Likert scaling is a bipolar scaling method, measuring either positive or negative response to a statement. The responses in this study might be 1.Strongly disagree, 2.Disagree, 3.Agree 4. Strongly agree, answers ranging from 1 point (strongly disagree) to 4 points (strongly agree). Low amount of points represent a better outcome. | from first birth in the study until last birth in the study (start of study until study completion an average of 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delivering Women