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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Safety measured by number of Adverse Events and Adverse Device Effects
研究概览
简要总结
"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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Multiple pregnancies
- •Breech position
- •Small for gestational age (<
- •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
研究组 & 干预措施
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.
干预措施: Vibwife One (Device)
结局指标
主要结局
Safety measured by number of Adverse Events and Adverse Device Effects
时间窗: 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.
次要结局
- Pain intensity(VAS before, during and after end of the intervention, intervention lasting up to 30 min.)
- Practicability measured by questionnaire(from first birth in the study until last birth in the study (start of study until study completion an average of 1 year))
- Preferences measured by questionnaire(within 30 minutes after end of the intervention, intervention lasting up to 30 min.)