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| Name | Class |
|---|---|
| Clinical Trial Unit, University Hospital Basel, Switzerland | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of the medical Device: Vibwife One | Other | 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:
During the intervention period, position and module might be changed once if required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibwife One | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of first stage of labor measured by hours | The first stage is defined from 4cm till full dilatation (10cm) of the cervix | assessed during birth |
| Duration of second stage of labor measured by hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Hösli, Prof. Dr. MD | Chief Physician Departement of Obstetrics and Antenatal care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23959763 | Background | Lawrence A, Lewis L, Hofmeyr GJ, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2013 Aug 20;(8):CD003934. doi: 10.1002/14651858.CD003934.pub3. | |
| 23415350 | Background | Nieuwenhuijze MJ, de Jonge A, Korstjens I, Bude L, Lagro-Janssen TL. Influence on birthing positions affects women's sense of control in second stage of labour. Midwifery. 2013 Nov;29(11):e107-14. doi: 10.1016/j.midw.2012.12.007. Epub 2013 Feb 15. |
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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:
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.
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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) |
The second stage is defined as part of labor from the full dilatation of the Cervix until birth
| assessed during birth |
| Delivery Outcome measured by frequency of route of delivery | Frequencies and means of characteristics of delivery (spontaneous versus vaginal instrumental versus caesarian section) | from first birth in the study until last birth in the study (start of study until study completion an average of 1 year) |