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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03443349
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.


Condition or disease Intervention/treatment Phase
Medical Device Device: Vibwife One Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
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
Actual Study Start Date : January 23, 2018
Actual Primary Completion Date : November 6, 2018
Actual Study Completion Date : November 6, 2018

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Safety measured by number of Adverse Events and Adverse Device Effects [ Time Frame: During intervention and until 30min. after end of intervention ]
    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.


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: VAS before, during and after end of the intervention, intervention lasting up to 30 min. ]
    Pain intensity is measured by a discrete Visual Analogue Scale (VAS) from 0-10, 0 indicating no pain until 10 indicating greatest pain

  2. Preferences measured by questionnaire [ Time Frame: within 30 minutes after end of the intervention, intervention lasting up to 30 min. ]
    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.

  3. Practicability measured by questionnaire [ Time Frame: from first birth in the study until last birth in the study (start of study until study completion an average of 1 year) ]
    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.


Other Outcome Measures:
  1. Duration of first stage of labor measured by hours [ Time Frame: assessed during birth ]
    The first stage is defined from 4cm till full dilatation (10cm) of the cervix

  2. Duration of second stage of labor measured by hours [ Time Frame: assessed during birth ]
    The second stage is defined as part of labor from the full dilatation of the Cervix until birth

  3. Delivery Outcome measured by frequency of route of delivery [ Time Frame: from first birth in the study until last birth in the study (start of study until study completion an average of 1 year) ]
    Frequencies and means of characteristics of delivery (spontaneous versus vaginal instrumental versus caesarian section)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443349


Locations
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Switzerland
University Hospital Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
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Principal Investigator: Irene Hösli, Prof. Dr. MD Chief Physician Departement of Obstetrics and Antenatal care

Publications:
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03443349     History of Changes
Other Study ID Numbers: 2017-02085
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Delivering Women