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

Medical Device Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443349
• Other study ID #: 2017-02085
• Status: Completed
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: November 6, 2018

Study information

• Verified date: November 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Device

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. Review. Update in: Cochrane Database Syst Rev. 2013;(10):CD003934. — View Citation

Nieuwenhuijze MJ, de Jonge A, Korstjens I, Budé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Duration of second stage of labor measured by hours	The second stage is defined as part of labor from the full dilatation of the Cervix until birth	assessed during birth
Other	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)
Primary	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	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.
Secondary	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.
Secondary	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)