Clinical trial NCT03066726: Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?
Official title: Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebroplacental Ratio
Keywords: Biophysical profile
Cesarean section
Estimated fetal weight
Middle cerebral artery
Umbilical artery
Fetal growth restriction
Pulsatility index
Estimated gestational age
Doppler
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Virtua Medical Group
name: Columbia University
name: Saint Peters University Hospital
name: Winthrop University Hospital
name: New York Presbyterian Queens
First posted: 2017-02-28
Enrollment: 580
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cesarean delivery
timeFrame: From labor to delivery
Secondary outcomes:
measure: Total cesarean section rate
timeFrame: From labor to delivery
measure: Cord blood gases
timeFrame: At the time of delivery
measure: Cases of small for gestational age undetected prenatally
timeFrame: At time of delivery
measure: Birthweight/ birthweight percentile
timeFrame: At time of delivery
measure: Incidence of category 2 or 3 tracings
timeFrame: During labor
measure: Distribution of CPR by estimated fetal weight
timeFrame: Measured during ultrasound between 36 weeks gestational age and delivery of the pregnancy.
measure: Rate of operative vaginal delivery
timeFrame: At time of delivery
measure: Neonatal Intensive Care Unit admission
timeFrame: Up to 28 days from delivery of the pregnancy
measure: Apgar scores at 1 and 5 minute
timeFrame: Scores assigned at 1 and 5 minutes of life by clinical staff.
measure: Composite neonatal outcome
timeFrame: Up to 28 days from delivery of the pregnancy.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peters University Hospital
state: New Jersey
city: Sewell
country: United States
facility: Virtua Medical Group
state: New Jersey
city: Flushing
country: United States
facility: New York Presbyterian-Queens Hospital
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Todd Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.