Clinical trial NCT03443349: "Vibwife One" a New Medical Device to Support Delivering Women in Their Mobilization
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Device
Keywords: Delivering Women
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2018-02-23
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Safety measured by number of Adverse Events and Adverse Device Effects
timeFrame: During intervention and until 30min. after end of intervention
Secondary outcomes:
measure: Pain intensity
timeFrame: VAS before, during and after end of the intervention, intervention lasting up to 30 min.
measure: Preferences measured by questionnaire
timeFrame: within 30 minutes after end of the intervention, intervention lasting up to 30 min.
measure: Practicability measured by questionnaire
timeFrame: from first birth in the study until last birth in the study (start of study until study completion an average of 1 year)
Other outcomes:
measure: Duration of first stage of labor measured by hours
timeFrame: assessed during birth
measure: Duration of second stage of labor measured by hours
timeFrame: assessed during birth
measure: Delivery Outcome measured by frequency of route of delivery
timeFrame: from first birth in the study until last birth in the study (start of study until study completion an average of 1 year)
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
Study officials:
affiliation: Chief Physician Departement of Obstetrics and Antenatal care
name: Irene Hösli, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.