Medical DeviceNCT03443349
"Vibwife One" a New Medical Device to Support Delivering Women in Their Mobilization
A study testing Vibwife One in people with Medical Device, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medical Device
- What is being tested?
- Vibwife One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jan 2018to 6 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent documented by signature
- German or English speaking
- Singleton healthy pregnancy
- Cephalic presentation
- ≥37th weeks of gestation
- 4cm - 9cm of dilatation
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- Regular contractions
- Physiological cardiotocograph (CTG) 30 min pre-intervention
- Physiological blood pressure (111/66 - 139/89)
Who cannot join
- Multiple pregnancies
- Breech position
- Small for gestational age (<10. Percentile)
- Fetal congenital abnormalities
- Placenta praevia
- Fetal distress
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
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
"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.
Read more
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.
Read the 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.
- Conditions
- Medical Device
- Being tested
- Vibwife One
- Keywords
- Delivering Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibwife OneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
* 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. Receives: Device: Vibwife One |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During intervention and until 30min. after end of intervention
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: from first birth in the study until last birth in the study (start of study until study completion an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start23 Jan 2018
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medical DeviceStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Irene Hösli, Prof. Dr. MD, Principal investigator, Chief Physician Departement of Obstetrics and Antenatal care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443349
- Sponsor's protocol ID
- 2017-02085
- Other IDs
- 2017
- Status last verified
- Nov 2018
- First submitted
- 2 Jan 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23959763Nieuwenhuijze 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.
PubMed 23415350
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03443349
- Acronym / sponsor ID
- 2017-02085
- Conditions
- Medical Device
- Keywords
- Delivering Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Use of the medical Device: Vibwife One | Other | Device: Vibwife OneThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent documented by signature
- German or English speaking
- Singleton healthy pregnancy
- Cephalic presentation
- ≥37th weeks of gestation
Key exclusion criteria (14 listed)
- Multiple pregnancies
- Breech position
- Small for gestational age (<10. Percentile)
- Fetal congenital abnormalities
- Placenta praevia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibwife OneVibwife 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. | Device | Use of the medical Device: Vibwife One |
Primary outcome
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.
3 secondary outcomes
Pain intensity
Time frame: VAS before, during and after end of the intervention, intervention lasting up to 30 min.
Preferences measured by questionnaire
Time frame: within 30 minutes after end of the intervention, intervention lasting up to 30 min.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Background: PubMed 23959763Lawrence 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.
- Background: PubMed 23415350Nieuwenhuijze 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Hösli, Prof. Dr. MD principal investigator
Chief Physician Departement of Obstetrics and Antenatal care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibwife One in people with Medical Device, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by number of Adverse Events and Adverse Device Effects (time frame: During intervention and until 30min. after end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.