Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 580
- 试验地点
- 6
- 主要终点
- Cesarean delivery
研究概览
简要总结
Ultrasound Doppler studies are used during pregnancy to help manage pregnancies complicated by fetal growth restriction. The cerebroplacental ratio may predict adverse outcomes in low risk pregnancies. In a prospective study, the investigators will examine whether fetuses with an abnormal CPR at or near term are at increased risk for being delivered by cesarean,
详细描述
This is a multicenter prospective study of low-risk nulliparous women who will be recruited if they are having an ultrasound at 36 weeks of estimated gestational age or greater. As part of the study, women will have umbilical and middle cerebral artery Doppler studies and the CPR will be calculated by dividing the middle cerebral artery PI by the umbilical artery PI. Providers caring for study subjects will be blinded to this result. Pregnancy outcomes in women with CPR values less than the 10th percentile for gestational age will be compared to those with CPR values above the 10th percentile.
A secondary aim of the study is to analyze CPR as a continuous variable.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous pregnant women between the ages of 18 and 45 years with low risk pregnancies who present for obstetrical ultrasound at 36 weeks of gestation or later with a planned delivery at a Perinatal Research Consortium hospital.
排除标准
- •Multifetal pregnancy at the time of presentation
- •Known fetal chromosomal anomaly
- •Known fetal malformation
- •Preeclampsia
- •Fetal growth restriction
- •Multiparity
- •Prior cesarean section
- •Placental abnormalities such as previa or accreta
- •Pregestational diabetes
- •Plan to deliver outside the Perinatal Research Consortium affiliated hospitals
结局指标
主要结局
Cesarean delivery
时间窗: From labor to delivery
Cesarean delivery rate for non reassuring fetal heart tracings
次要结局
- Cases of small for gestational age undetected prenatally(At time of delivery)
- Cord blood gases(At the time of delivery)
- Incidence of category 2 or 3 tracings(During labor)
- Rate of operative vaginal delivery(At time of delivery)
- Total cesarean section rate(From labor to delivery)
- Birthweight/ birthweight percentile(At time of delivery)
- Distribution of CPR by estimated fetal weight(Measured during ultrasound between 36 weeks gestational age and delivery of the pregnancy.)
- Neonatal Intensive Care Unit admission(Up to 28 days from delivery of the pregnancy)
- Apgar scores at 1 and 5 minute(Scores assigned at 1 and 5 minutes of life by clinical staff.)
- Composite neonatal outcome(Up to 28 days from delivery of the pregnancy.)
研究者
Todd Rosen, MD
Director, Maternal-Fetal Medicine
Rutgers, The State University of New Jersey