- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03066726
Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies? (CPR)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Mayra Cruz Ithier, MD, MS
- Phone Number: 301 335-2262
- Email: mayra.cruzithier@rutgers.edu
Study Locations
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Saint Peters University Hospital
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New Brunswick, New Jersey, United States, 08901
- Rutgers, The State University of New Jersey
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Sewell, New Jersey, United States, 08080
- Virtua Medical Group
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New York
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Flushing, New York, United States, 11355
- New York Presbyterian-Queens Hospital
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Mineola, New York, United States, 11501
- Winthrop University Hospital
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New York, New York, United States, 10032
- Columbia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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CPR greater or equal than 10%le
Group of patients with fetuses with cerebroplacental ratio greater or equal than 10%le
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cesarean delivery
Time Frame: From labor to delivery
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Cesarean delivery rate for non reassuring fetal heart tracings
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From labor to delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cesarean section rate
Time Frame: From labor to delivery
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Cesarean delivery rate for other indications other than non reassuring fetal heart tracings
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From labor to delivery
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Cord blood gases
Time Frame: At the time of delivery
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If obtained by the provider, umbilical (arterial or venous) cord pH
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At the time of delivery
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Cases of small for gestational age undetected prenatally
Time Frame: At time of delivery
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Neonates that were small for gestational age at time of delivery but were not detected prenatally
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At time of delivery
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Birthweight/ birthweight percentile
Time Frame: At time of delivery
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Neonate birth weight and percentiles according to established weight charts will be recorded
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At time of delivery
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Incidence of category 2 or 3 tracings
Time Frame: During labor
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As defined by the National Institutes of Health-National Institute of Child Health and Human Development Fetal Heart Tracings definitions and classifications
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During labor
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Distribution of CPR by estimated fetal weight
Time Frame: Measured during ultrasound between 36 weeks gestational age and delivery of the pregnancy.
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We will assess whether there is an association between the CPR and sonographic estimation of fetal weight.
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Measured during ultrasound between 36 weeks gestational age and delivery of the pregnancy.
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Rate of operative vaginal delivery
Time Frame: At time of delivery
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Vaginal deliveries needing forceps or vacuum assistance
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At time of delivery
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Neonatal Intensive Care Unit admission
Time Frame: Up to 28 days from delivery of the pregnancy
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Percentage of neonates admitted to the neonatal intensive care unit
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Up to 28 days from delivery of the pregnancy
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Apgar scores at 1 and 5 minute
Time Frame: Scores assigned at 1 and 5 minutes of life by clinical staff.
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Standard assessment tool applied to all neonates in participating centers by clinical staff
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Scores assigned at 1 and 5 minutes of life by clinical staff.
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Composite neonatal outcome
Time Frame: Up to 28 days from delivery of the pregnancy.
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The investigators will record a composite neonatal outcome including-respiratory distress, apnea, infection, hypoglycemia, hyperbilirubinemia, hypothermia, neurologic complication and neonatal death.
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Up to 28 days from delivery of the pregnancy.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Todd Rosen, MD, Rutgers, The State University of New Jersey
Publications and helpful links
General Publications
- 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.
- Morales-Rosello 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RU10312017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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