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

NCT ID: NCT03443349

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-23
• Study Completion Date: 2018-11-06

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.

Conditions

Medical Device

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Vibwife One

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trial Unit, University Hospital Basel, Switzerland

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene Hösli, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

Chief Physician Departement of Obstetrics and Antenatal care

Locations

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 23959763 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23415350 (View on PubMed)

Other Identifiers

2017-02085

Identifier Type: -

Identifier Source: org_study_id