Cerebroplacental RatioCPRNCT03066726
Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?
An observational study of Cerebroplacental Ratio, run by Rutgers, The State University of New Jersey at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cerebroplacental Ratio
- How many people
- 580 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 May 2017to 7 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Multifetal pregnancy at the time of presentation
- Known fetal chromosomal anomaly
- Known fetal malformation
- Preeclampsia
- Fetal growth restriction
- Multiparity
Show all 10Show fewer
- Prior cesarean section
- Placental abnormalities such as previa or accreta
- Pregestational diabetes
- Plan to deliver outside the Perinatal Research Consortium affiliated hospitals
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
New York Presbyterian-Queens Hospital
Flushing, New York, 11355
Winthrop University Hospital
Mineola, New York, 11501
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901
Saint Peters University Hospital
New Brunswick, New Jersey, 08901
Columbia University
New York, New York, 10032
Virtua Medical Group
Sewell, New Jersey, 08080
About this study
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,
Read the 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.
- 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
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean delivery
Cesarean delivery rate for non reassuring fetal heart tracings
Measured: From labor to delivery
Secondary outcomes (10)
Total cesarean section rate
Cesarean delivery rate for other indications other than non reassuring fetal heart tracings
Measured: From labor to delivery
Cord blood gases
If obtained by the provider, umbilical (arterial or venous) cord pH
Measured: 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
Measured: At time of delivery
Birthweight/ birthweight percentile
Neonate birth weight and percentiles according to established weight charts will be recorded
Measured: 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
Measured: 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.
Measured: 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
Measured: At time of delivery
Neonatal Intensive Care Unit admission
Percentage of neonates admitted to the neonatal intensive care unit
Measured: 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
Measured: 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.
Measured: Up to 28 days from delivery of the pregnancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start15 May 2017
- Primary completion7 May 2020
- Study completion7 May 2020
Why it stopped: Unable to meet recruitment target
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebroplacental RatioStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Virtua Medical Group, Columbia University, Saint Peters University Hospital, Winthrop University Hospital, New York Presbyterian Hospital
- Responsible party
- Principal investigator, Todd Rosen, MD, Rutgers, The State University of New Jersey
- Investigators
- Todd Rosen, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066726
- Sponsor's protocol ID
- RU10312017
- Acronym
- CPR
- Status last verified
- Jan 2023
- First submitted
- 8 Feb 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23159689Figueras 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.
PubMed 25358519DeVore 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.
PubMed 26113227Morales-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.
PubMed 24488879
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?
- ClinicalTrials.gov ID
- NCT03066726
- Acronym / sponsor ID
- CPR / RU10312017
- Conditions
- Cerebroplacental Ratio
- Keywords
- Biophysical profile, Cesarean section, Estimated fetal weight, Middle cerebral artery, Umbilical artery, Fetal growth restriction, Pulsatility index, Estimated gestational age
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to meet recruitment target
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Virtua Medical Group, Columbia University, Saint Peters University Hospital, Winthrop University Hospital, New York Presbyterian Hospital
- Study start
- 15 May 2017 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- Multifetal pregnancy at the time of presentation
- Known fetal chromosomal anomaly
- Known fetal malformation
- Preeclampsia
- Fetal growth restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cesarean delivery
Time frame: From labor to delivery
Cesarean delivery rate for non reassuring fetal heart tracings
10 secondary outcomes
Total cesarean section rate
Time frame: From labor to delivery
Cord blood gases
Time frame: At the time of delivery
Cases of small for gestational age undetected prenatally
Time frame: At time of delivery
Birthweight/ birthweight percentile
Time frame: At time of delivery
Incidence of category 2 or 3 tracings
Time frame: During labor
Distribution of CPR by estimated fetal weight
Time frame: Measured during ultrasound between 36 weeks gestational age and delivery of the pregnancy.
Rate of operative vaginal delivery
Time frame: At time of delivery
Neonatal Intensive Care Unit admission
Time frame: Up to 28 days from delivery of the pregnancy
Apgar scores at 1 and 5 minute
Time frame: Scores assigned at 1 and 5 minutes of life by clinical staff.
Composite neonatal outcome
Time frame: Up to 28 days from delivery of the pregnancy.
Results and safety
The study was stopped early (reason given: Unable to meet recruitment target). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 23159689Prior 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.
- Background: PubMed 25358519Figueras 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.
- Background: PubMed 26113227DeVore 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.
- Results publication: PubMed 24488879Morales-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Rosen, MD principal investigator
Rutgers, The State University of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebroplacental Ratio, run by Rutgers, The State University of New Jersey at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to meet recruitment target). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean delivery (time frame: From labor to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03066726, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.