ACTRN12624000925549尚未招募Unknown
Feasibility and reliability of a novel biosensor for continuous monitoring of fetal scalp lactate during labour and delivery: a phase 1 study
VitalTrace Pty Ltd0 个研究点目标入组 20 人开始时间: 2024年7月31日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Participant
- •1.Informed written consent, confirmed verbally on admission to Birthing Unit
- •2.Cervical dilatation sufficient for application of DelivAssure device
- •3.Established labour
- •4.Uncomplicated term pregnancy
- •5.Rupture membranes with clear amniotic fluid
- •6.No concern over fetal welfare
- •7.Vaginal birth anticipated
- •1. Involvement in caring for a woman/fetus participating in the FILM1 study
- •2. Attendance at a focus group or individual interview
排除标准
- •Participants
- •1 Anticipated birth within 60 minutes
- •2.Requirement for fetal scalp clip for fetal monitoring
- •3.Maternal infections: HIV, Hepatitis C, Hepatitis B positive, Group B streptococcus positive, history of Herpes Simplex Type II
- •4.Clinical chorioamnionitis as evidenced by maternal temperature >37.50C an/or fetal baseline heart rate >180bpm and/or offensive smellingamniotic fluid
- •5.Proven or suspected fetal bleeding disorder
- •6.Prolonged rupture of the membranes (over 12 hours)
- •Clinicians - no exclusion criteria
研究者
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