An observational study in Cerebroplacental Ratio, sponsored by Rutgers, The State University of New Jersey. Terminated at 6 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Rutgers, The State University of New Jersey · Observational
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,
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.
Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Group of patients with fetuses with cerebroplacental ratio less than 10%le
Group of patients with fetuses with cerebroplacental ratio greater or equal than 10%le
Cesarean delivery
Cesarean delivery rate for non reassuring fetal heart tracings
Time frame: From labor to delivery
Total cesarean section rate
Cesarean delivery rate for other indications other than non reassuring fetal heart tracings
Time frame: From labor to delivery
Cord blood gases
If obtained by the provider, umbilical (arterial or venous) cord pH
Time frame: 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
Time frame: At time of delivery
Birthweight/ birthweight percentile
Neonate birth weight and percentiles according to established weight charts will be recorded
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: At time of delivery
Neonatal Intensive Care Unit admission
Percentage of neonates admitted to the neonatal intensive care unit
Time frame: 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
Time frame: 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.
Time frame: Up to 28 days from delivery of the pregnancy.
Plan to share: No
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey