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

Overview

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,

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2019

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.

Arms, Groups and Cohorts

  • CPR less than the 10%le
    • Group of patients with fetuses with cerebroplacental ratio less than 10%le
  • CPR greater or equal than 10%le
    • Group of patients with fetuses with cerebroplacental ratio greater or equal than 10%le

Clinical Trial Outcome Measures

Primary Measures

  • Cesarean delivery
    • Time Frame: From labor to delivery
    • Cesarean delivery rate for non reassuring fetal heart tracings

Secondary Measures

  • Total cesarean section rate
    • Time Frame: From labor to delivery
    • Cesarean delivery rate for other indications other than non reassuring fetal heart tracings
  • Cord blood gases
    • Time Frame: At the time of delivery
    • If obtained by the provider, umbilical (arterial or venous) cord pH
  • Cases of small for gestational age undetected prenatally
    • Time Frame: At time of delivery
    • Neonates that were small for gestational age at time of delivery but were not detected prenatally
  • Birthweight/ birthweight percentile
    • Time Frame: At time of delivery
    • Neonate birth weight and percentiles according to established weight charts will be recorded
  • Incidence of category 2 or 3 tracings
    • Time Frame: During labor
    • As defined by the National Institutes of Health-National Institute of Child Health and Human Development Fetal Heart Tracings definitions and classifications
  • Distribution of CPR by estimated fetal weight
    • Time Frame: 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.
  • Rate of operative vaginal delivery
    • Time Frame: At time of delivery
    • Vaginal deliveries needing forceps or vacuum assistance
  • Neonatal Intensive Care Unit admission
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Collaborator
    • Virtua Medical Group
  • Provider of Information About this Clinical Study
    • Principal Investigator: Todd Rosen, MD, Director, Maternal-Fetal Medicine – Rutgers, The State University of New Jersey
  • Overall Official(s)
    • Todd Rosen, MD, Principal Investigator, Rutgers, The State University of New Jersey
  • Overall Contact(s)
    • Mayra Cruz Ithier, MD, MS, 301 335-2262, mayra.cruzithier@rutgers.edu

References

Prior T, Mullins E, Bennett P, Kumar S. Prediction of intrapartum fetal compromise using the cerebroumbilical ratio: a prospective observational study. Am J Obstet Gynecol. 2013 Feb;208(2):124.e1-6. doi: 10.1016/j.ajog.2012.11.016. Epub 2012 Nov 15.

Figueras F, Savchev S, Triunfo S, Crovetto F, Gratacos E. An integrated model with classification criteria to predict small-for-gestational-age fetuses at risk of adverse perinatal outcome. Ultrasound Obstet Gynecol. 2015 Mar;45(3):279-85. doi: 10.1002/uog.14714. Epub 2015 Jan 27.

DeVore GR. The importance of the cerebroplacental ratio in the evaluation of fetal well-being in SGA and AGA fetuses. Am J Obstet Gynecol. 2015 Jul;213(1):5-15. doi: 10.1016/j.ajog.2015.05.024. Review.

Citations Reporting on Results

Morales-Roselló J, Khalil A, Morlando M, Papageorghiou A, Bhide A, Thilaganathan B. Changes in fetal Doppler indices as a marker of failure to reach growth potential at term. Ultrasound Obstet Gynecol. 2014 Mar;43(3):303-10. doi: 10.1002/uog.13319.

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