Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Neonatal outcome 1; based on gestational age
研究概览
简要总结
In this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation.
详细描述
Although, to this date, there have been a number of human placental studies that concerned the evaluation of placental 3 dimensional power Doppler vascularization with the use of VOCAL technique, but there was no one in which placental vasculature has been compared between the sonobiopsy and whole placental volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Exclusion criteria:
- •multiple pregnancy,
- •abnormal (> 3mm) nuchal translucency from 11+0 to 13+6 weeks of gestation,
- •the fetal or neonatal structural or chromosomal anomaly,
- •inadequate localization of the placenta (placenta praevia),
- •self-reported drugs, alcohol, caffeine or nicotine abuse,
- •exposed to circulatory medication (oxerutins, calcium dobesilate)
- •or not signing the consent form.
- •If the mother suffer from er systemic disease (e.g. diabetes, autoimmune disease, vasculitis, haemophilia, thrombophilia, HIV infection, etc)
- •Inclusion clriteria:
- •single pregnancy
- •healthy pregnant women
- •no anatomical alteration of fetus
- •no genetical abnormality of fetus
排除标准
- 未提供
结局指标
主要结局
Neonatal outcome 1; based on gestational age
时间窗: during first day of life
The participants were recorded by gestational age et birth
Neonatal outcome 6; delivery complication
时间窗: during first day of life
Delivery complication ( cesarean section due to fetal distress)
Neonatal outcome 7, necessary of intensive care unit
时间窗: during first week of life
Neonates transfer to neonatal intensive care unit (NICU)
Neonatal outcome 3, (birth weight of newborns)
时间窗: during first day of life
Neonates birth weight calculation (gram)
Maternal characteristics (BMI)
时间窗: through study completion, 2 years
The pre-pregnancy body mass index (BMI) registered at the initial visit during prenatal care was calculated as the body weight (kg) per height (m2).
Neonatal outcome 4; Apgar score
时间窗: during first day of life
Neonates poor adaptation status (Apgar score (\<7) at 5 minutes)
Neonatal outcome 5, (umbilical cord pH)
时间窗: during first day of life
Neonates poor adaptation status (umbilical cord pH \<7.2)
Neonatal outcome 2, based on maturation of neonates
时间窗: during first day of life
Neonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity
次要结局
- 2D ultrasound investigaiotn of gestation (fetal biometry, placentation)(during prenatal care till the labour)
研究者
Andrea Suranyi
Head of placenta study group
Szeged University