Cerebroplacental Ratio Clinical Trial
— CPROfficial title:
Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?
| NCT number | NCT03066726 |
| Other study ID # | RU10312017 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 15, 2017 |
| Est. completion date | May 7, 2020 |
| Verified date | January 2023 |
| Source | Rutgers, The State University of New Jersey |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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,
| Status | Terminated |
| Enrollment | 580 |
| Est. completion date | May 7, 2020 |
| Est. primary completion date | May 7, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | New York Presbyterian-Queens Hospital | Flushing | New York |
| United States | Winthrop University Hospital | Mineola | New York |
| United States | Rutgers, The State University of New Jersey | New Brunswick | New Jersey |
| United States | Saint Peters University Hospital | New Brunswick | New Jersey |
| United States | Columbia University | New York | New York |
| United States | Virtua Medical Group | Sewell | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Rutgers, The State University of New Jersey | Columbia University, New York Presbyterian Queens, Saint Peters University Hospital, Virtua Medical Group, Winthrop University Hospital |
United States,
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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cesarean delivery | Cesarean delivery rate for non reassuring fetal heart tracings | From labor to delivery | |
| Secondary | Total cesarean section rate | Cesarean delivery rate for other indications other than non reassuring fetal heart tracings | From labor to delivery | |
| Secondary | Cord blood gases | If obtained by the provider, umbilical (arterial or venous) cord pH | At the time of delivery | |
| Secondary | Cases of small for gestational age undetected prenatally | Neonates that were small for gestational age at time of delivery but were not detected prenatally | At time of delivery | |
| Secondary | Birthweight/ birthweight percentile | Neonate birth weight and percentiles according to established weight charts will be recorded | At time of delivery | |
| Secondary | 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 | During labor | |
| Secondary | 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 during ultrasound between 36 weeks gestational age and delivery of the pregnancy. | |
| Secondary | Rate of operative vaginal delivery | Vaginal deliveries needing forceps or vacuum assistance | At time of delivery | |
| Secondary | Neonatal Intensive Care Unit admission | Percentage of neonates admitted to the neonatal intensive care unit | Up to 28 days from delivery of the pregnancy | |
| Secondary | Apgar scores at 1 and 5 minute | Standard assessment tool applied to all neonates in participating centers by clinical staff | Scores assigned at 1 and 5 minutes of life by clinical staff. | |
| Secondary | Composite neonatal outcome | The investigators will record a composite neonatal outcome including-respiratory distress, apnea, infection, hypoglycemia, hyperbilirubinemia, hypothermia, neurologic complication and neonatal death. | Up to 28 days from delivery of the pregnancy. |