"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

"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.

Study Overview

• Status: Completed
• Conditions: Medical Device
• Intervention / Treatment: Device: Vibwife One

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4031
      • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Use of the medical Device: Vibwife One; 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; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland
• Investigators: Principal Investigator: Irene Hösli, Prof. Dr. MD, Chief Physician Departement of Obstetrics and Antenatal care

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): November 6, 2018
• Study Completion (Actual): November 6, 2018

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Delivering Women
• Other Study ID Numbers: 2017-02085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No