The PREPPeD Study: "PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Newborn asphyxia
研究概览
简要总结
The PREPPeD study proposes that predelivery placenta-derived maternal circulating biomarkers reflect placental health, capacity and ageing, and can help predict onset and complications of delivery both in complicated pregnancies as well as in clinically uncomplicated term/post-term pregnancies.
详细描述
The main aim of the PREPPeD study is to explore whether placental health, evaluated by maternal blood biomarkers in late pregnancy, correlates with delivery outcomes in both healthy and complicated pregnancies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All pregnant women scheduled to deliver at the Department of Obstetrics at OUH who qualify for the study groups as specified in the "Groups and Intervention" section.
排除标准
- •Women who do not understand Norwegian or English
- •Communicable disease
- •Younger than 18 years of age
- •Legally incompetent
- •Fetal malformations
结局指标
主要结局
Newborn asphyxia
时间窗: Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months
Combination of outcomes 1 and 2
Fetal acidaemia
时间窗: Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months
In neonates delivered by cesarean section (CS) without labour (defined as absence of regular uterine contractions): Umbilical artery blood (transporting blood from the fetus to the placenta) pH\<7.13 and arterial BD \>10.0 In neonates from labored delivery (regardless of subsequent delivery method, vaginal or CS): Umbilical artery blood pH\<7.05 and arterial BD\>14; OR Umbilical artery blood (or venous if arterial blood not available) lactate above Reference level for respective gestational age according to publication by Wiberg N et al ,BJOG 2008 (doi: 10.1111/j.1471-0528.2008.01707.x.)
Newborn low Apgar score
时间窗: Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months
\<4 at 1 minute OR \<7 at 5 minutes
Meconium aspiration syndrome
时间窗: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Rate of acute cesarean section (due to suspected fetal distress)
时间窗: Data assessed throughout study period of 140 months
Rate of intrauterine fetal demise/intra-/postpartum fetal death
时间窗: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal intubation/mechanical ventilation>6 hours
时间窗: Within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal hypoxic-ischemic encephalopathy
时间窗: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Therapeutic hypothermia of the neonate
时间窗: Within 3 days postpartum; data assessed throughout study period of 140 months
次要结局
- Pathological placenta histology findings(Data assessed throughout study period of 140 months)
- Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress)(Data assessed throughout study period of 140 months)
- Abnormal intrapartum CTG patterns(Intrapartum CTG; data assessed throughout study period of 140 months)
研究者
Meryam Sugulle
Consultant Obstetrician
Oslo University Hospital