Placental Growth and Adverse Pregnancy Outcomes
The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.
Hypertension Induced by Pregnancy
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome|
- Small for gestational birth weight (SGA-dichotomous) [ Time Frame: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks) ] [ Designated as safety issue: No ]Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.
- Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death. [ Time Frame: post partum ] [ Designated as safety issue: No ]Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum.
Biospecimen Retention: Samples Without DNA
Maternal serum will be collected. Placental biopsies may be collected.
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation.
The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed for measurement of placental volumes during pregnancy. It may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. Furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. The investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669525
|United States, Pennsylvania|
|University of Pennsylvania Health System|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Nadav Schwartz, MD||University of Pennsylvania|