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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: Rutgers, The State University of New Jersey

Current Primary Outcome: Cesarean delivery [ Time Frame: From labor to delivery ]

Cesarean delivery rate for non reassuring fetal heart tracings


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: February 8, 2017
Date Started: May 15, 2017
Date Completion: September 1, 2018
Last Updated: April 11, 2017
Last Verified: April 2017