NCT06442358已完成不适用
BPP for ME: Self Biophysical Profile Proof of Concept
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PulseNmore
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being
研究概览
简要总结
The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age ≥ 18 years old
- •Singleton pregnancy
- •Gestational age ≥ 24 0/7 weeks
- •No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
- •Ability to understand and sign informed consent in English
- •Ability to read and understand instructions in English
- •Ability to hold an ultrasound probe and respond to clinician instructions
- •BMI less than 40 at initial prenatal visit
- •Scheduled biophysical profile (BPP)
- •Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.
排除标准
- •Multiple gestation
- •Known major fetal structural anomaly or aneuploidy
- •Known fetal or genetic anomalies
- •Ruptured membranes
- •Uterine complaints, such as painful contractions
- •Maternal concern for decreased fetal movement
- •Not evaluated vaginal bleeding (not including spotting)
- •Fetal or maternal criteria that require urgent delivery
- •BMI ≥ 40 at initial prenatal visit
结局指标
主要结局
Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being
时间窗: One day
Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level
次要结局
- Assess preliminary effectiveness and compare participant results to standard of care BPP(One day)
- Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.(One day)
研究者
研究点 (2)
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