Cerebroplacental Ratio
Conditions
Keywords
Biophysical profile, Cesarean section, Estimated fetal weight, Middle cerebral artery, Umbilical artery, Fetal growth restriction, Pulsatility index, Estimated gestational age, Doppler
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.
Interventions
None listed
Sponsors
Virtua Medical Group
Columbia University
Saint Peters University Hospital
Winthrop University Hospital
New York Presbyterian Queens
Rutgers, The State University of New Jersey
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean delivery | From labor to delivery | Cesarean delivery rate for non reassuring fetal heart tracings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cord blood gases | At the time of delivery | If obtained by the provider, umbilical (arterial or venous) cord pH |
| 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 |
| Birthweight/ birthweight percentile | At time of delivery | Neonate birth weight and percentiles according to established weight charts will be recorded |
| 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 |
| Total cesarean section rate | From labor to delivery | Cesarean delivery rate for other indications other than non reassuring fetal heart tracings |
| Rate of operative vaginal delivery | At time of delivery | Vaginal deliveries needing forceps or vacuum assistance |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed