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Unable to meet recruitment target
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| Name | Class |
|---|---|
| Virtua Medical Group | OTHER |
| Columbia University | OTHER |
| Saint Peters University Hospital | OTHER |
| Winthrop University Hospital |
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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,
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Cesarean delivery | Cesarean delivery rate for non reassuring fetal heart tracings | From labor to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Total cesarean section rate | Cesarean delivery rate for other indications other than non reassuring fetal heart tracings | From labor to delivery |
| Cord blood gases | If obtained by the provider, umbilical (arterial or venous) cord pH |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Rosen, MD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers, The State University of New Jersey | New Brunswick | New Jersey | 08901 | United States | ||
| Saint Peters University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23159689 | Background | 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. | |
| 25358519 | 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. |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| OTHER |
| New York Presbyterian Queens | UNKNOWN |
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| 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 | At time of delivery |
| Birthweight/ birthweight percentile | Neonate birth weight and percentiles according to established weight charts will be recorded | 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 | 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 during ultrasound between 36 weeks gestational age and delivery of the pregnancy. |
| Rate of operative vaginal delivery | Vaginal deliveries needing forceps or vacuum assistance | At time of delivery |
| Neonatal Intensive Care Unit admission | Percentage of neonates admitted to the neonatal intensive care unit | 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 | 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. | Up to 28 days from delivery of the pregnancy. |
| 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 |
| 26113227 | 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. |
| 24488879 | Result | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |