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

NCT03066726 | Terminated DMC

• 1 other identifier: RU10312017
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 6

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,

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

Outcome Measures

Primary Outcomes (1)

• Cesarean delivery

  Cesarean delivery rate for non reassuring fetal heart tracings

  From labor to delivery

Secondary Outcomes (10)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Virtua Medical Group: collaborator
• Columbia University: collaborator
• Saint Peters University Hospital: collaborator
• Winthrop University Hospital: collaborator
• New York Presbyterian Queens: collaborator

Study Sites (6)

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Saint Peters University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Virtua Medical Group

Sewell, New Jersey, 08080, United States

Location

New York Presbyterian-Queens Hospital

Flushing, New York, 11355, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Related Publications (4)

• 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.

  PMID: 23159689 BACKGROUND

• 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.

  PMID: 25358519 BACKGROUND

• 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.

  PMID: 26113227 BACKGROUND

• 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.

  PMID: 24488879 RESULT

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd Rosen, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Maternal-Fetal Medicine

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 28, 2017
• Study Start: May 15, 2017
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)