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

University Hospital Basel

Status: Completed

Conditions: Medical Device

Treatments: Device: Vibwife One

Study type: Interventional

Funder types: Other

Identifiers

NCT03443349

2017-02085

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Use of the medical Device: Vibwife One

Other group

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.

Treatment:

Device: Vibwife One