This trial is active, not recruiting.

Conditions hypertension induced by pregnancy, pre-eclampsia, iugr
Sponsor University of Pennsylvania
Start date November 2009
End date October 2016
Trial size 1200 participants
Trial identifier NCT01669525, 811129


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation.

Primary Outcomes

Small for gestational birth weight (SGA-dichotomous)
time frame: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)

Secondary Outcomes

Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.
time frame: post partum

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - All singleton gestations presenting for Sequential Screen testing at HUP - patients competent to provide verbal informed consent Exclusion Criteria: - Multiple gestations - patients not competent to provide informed consent - patients found to be too late for the Sequential Screen - pregnancy losses 20 weeks gestation - major fetal anomalies - patient delivering outside of the UPHS

Additional Information

Official title Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome
Principal investigator Nadav Schwartz, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.