Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?
- Conditions
- Cerebroplacental Ratio
- Registration Number
- NCT03066726
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
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,
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 580
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cesarean delivery From labor to delivery Cesarean delivery rate for non reassuring fetal heart tracings
- Secondary Outcome Measures
Name Time Method Cases of small for gestational age undetected prenatally At time of delivery Neonates that were small for gestational age at time of delivery but were not detected prenatally
Cord blood gases At the time of delivery If obtained by the provider, umbilical (arterial or venous) cord pH
Incidence of category 2 or 3 tracings During labor As defined by the National Institutes of Health-National Institute of Child Health and Human Development Fetal Heart Tracings definitions and classifications
Rate of operative vaginal delivery At time of delivery Vaginal deliveries needing forceps or vacuum assistance
Total cesarean section rate From labor to delivery Cesarean delivery rate for other indications other than non reassuring fetal heart tracings
Birthweight/ birthweight percentile At time of delivery Neonate birth weight and percentiles according to established weight charts will be recorded
Distribution of CPR by estimated fetal weight Measured during ultrasound between 36 weeks gestational age and delivery of the pregnancy. We will assess whether there is an association between the CPR and sonographic estimation of fetal weight.
Neonatal Intensive Care Unit admission Up to 28 days from delivery of the pregnancy Percentage of neonates admitted to the neonatal intensive care unit
Apgar scores at 1 and 5 minute Scores assigned at 1 and 5 minutes of life by clinical staff. Standard assessment tool applied to all neonates in participating centers by clinical staff
Composite neonatal outcome Up to 28 days from delivery of the pregnancy. The investigators will record a composite neonatal outcome including-respiratory distress, apnea, infection, hypoglycemia, hyperbilirubinemia, hypothermia, neurologic complication and neonatal death.
Trial Locations
- Locations (6)
New York Presbyterian-Queens Hospital
🇺🇸Flushing, New York, United States
Columbia University
🇺🇸New York, New York, United States
Rutgers, The State University of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Virtua Medical Group
🇺🇸Sewell, New Jersey, United States
Saint Peters University Hospital
🇺🇸New Brunswick, New Jersey, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States