NCT03066726|TerminatedDMC
Study Stopped
Unable to meet recruitment target
Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?
CPR
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Sponsor study identifier
observational
580
1 country
6
Study Start
May 15, 2017
Actual (reported)Primary Completion
May 7, 2020
Actual (reported)Study Completion
May 7, 2020
Actual (reported)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,
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 7, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2017
Actual (reported)February 28, 2017
Actual (reported)May 15, 2017
Actual (reported)May 7, 2020
Actual (reported)May 7, 2020
Actual (reported)Cesarean delivery
Cesarean delivery rate for non reassuring fetal heart tracings
From labor to delivery
Total cesarean section rate
From labor to delivery
Cord blood gases
At the time of delivery
Cases of small for gestational age undetected prenatally
At time of delivery
Birthweight/ birthweight percentile
At time of delivery
Incidence of category 2 or 3 tracings
During labor
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
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.
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901, United States
Saint Peters University Hospital
New Brunswick, New Jersey, 08901, United States
Virtua Medical Group
Sewell, New Jersey, 08080, United States
New York Presbyterian-Queens Hospital
Flushing, New York, 11355, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Columbia University
New York, New York, 10032, United States
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.
Todd Rosen, MD
Rutgers, The State University of New Jersey
580 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2017
First Posted
February 28, 2017
Study Start
May 15, 2017
Actual (reported)Contact the study team to confirm eligibility.
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.
Primary Completion
May 7, 2020
Actual (reported)Study Completion
May 7, 2020
Actual (reported)Last Updated
January 18, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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