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

January 16, 2023 updated by: Todd Rosen, MD, Rutgers, The State University of New Jersey
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 Overview

Status

Terminated

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.

Study Type

Observational

Enrollment (Actual)

580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peters University Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers, The State University of New Jersey
      • Sewell, New Jersey, United States, 08080
        • Virtua Medical Group
    • New York
      • Flushing, New York, United States, 11355
        • New York Presbyterian-Queens Hospital
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This is a multicenter prospective study of low-risk nulliparous women who will be recruited if they are having an ultrasound at 36 weeks EGA or greater.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean delivery
Time Frame: From labor to 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
Time Frame: From labor to delivery
Cesarean delivery rate for other indications other than non reassuring fetal heart tracings
From labor to delivery
Cord blood gases
Time Frame: At the time of delivery
If obtained by the provider, umbilical (arterial or venous) cord pH
At the time of delivery
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
At time of delivery
Birthweight/ birthweight percentile
Time Frame: At time of delivery
Neonate birth weight and percentiles according to established weight charts will be recorded
At time of delivery
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
During labor
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.
Measured during ultrasound between 36 weeks gestational age and delivery of the pregnancy.
Rate of operative vaginal delivery
Time Frame: At time of delivery
Vaginal deliveries needing forceps or vacuum assistance
At time of delivery
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
Up to 28 days from delivery of the pregnancy
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
Scores assigned at 1 and 5 minutes of life 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.
Up to 28 days from delivery of the pregnancy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Todd Rosen, MD, Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

May 7, 2020

Study Completion (Actual)

May 7, 2020

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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