Status:
COMPLETED
"Vibwife One" a New Medical Device to Support Delivering Women in Their Mobilization
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Clinical Trial Unit, University Hospital Basel, Switzerland
Conditions:
Medical Device
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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:...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2018
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03443349
Start Date
January 23 2018
End Date
November 6 2018
Last Update
November 14 2018
Active Locations (1)
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1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031