Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?

Conditions
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Cerebroplacental Ratio

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPR less than the 10%le<br>Group of patients with fetuses with cerebroplacental ratio less than 10%le | |
| CPR greater or equal than 10%le<br>Group of patients with fetuses with cerebroplacental ratio greater or equal than 10%le | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean delivery | Cesarean delivery rate for non reassuring fetal heart tracings | From labor to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cesarean section rate | Cesarean delivery rate for other indications other than non reassuring fetal heart tracings | From labor to delivery | 
| Cord blood gases | If obtained by the provider, umbilical (arterial or venous) cord pH | At the time of delivery | 
| Cases of small for gestational age undetected prenatally | Neonates that were small for gestational age at time of delivery but were not detected prenatally | At time of delivery | 
| Birthweight/ birthweight percentile | Neonate birth weight and percentiles according to established weight charts will be recorded | At time of delivery | 
| Incidence of category 2 or 3 tracings | As defined by the National Institutes of Health-National Institute of Child Health and Human Development Fetal Heart Tracings definitions and classifications | During labor | 
| Distribution of CPR by estimated fetal weight | We will assess whether there is an association between the CPR and sonographic estimation of fetal weight. | Measured during ultrasound between 36 weeks gestational age and delivery of the pregnancy. | 
| Rate of operative vaginal delivery | Vaginal deliveries needing forceps or vacuum assistance | At time of delivery | 
| Neonatal Intensive Care Unit admission | Percentage of neonates admitted to the neonatal intensive care unit | Up to 28 days from delivery of the pregnancy | 
| Apgar scores at 1 and 5 minute | Standard assessment tool applied to all neonates in participating centers by clinical staff | Scores assigned at 1 and 5 minutes of life by clinical staff. | 
| Composite neonatal outcome | The investigators will record a composite neonatal outcome including-respiratory distress, apnea, infection, hypoglycemia, hyperbilirubinemia, hypothermia, neurologic complication and neonatal death. | Up to 28 days from delivery of the pregnancy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biophysical profile, Cesarean section, Estimated fetal weight, Middle cerebral artery, Umbilical artery, Fetal growth restriction, Pulsatility index, Estimated gestational age, Doppler