Placental Growth and Adverse Pregnancy Outcomes

Pre-Eclampsia Clinical Trial

Official title:

Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669525
• Other study ID #: 811129
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: July 17, 2017
• Start date: November 2009
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1043
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Hypertension Induced by Pregnancy
• Hypertension, Pregnancy-Induced
• IUGR
• Pre-Eclampsia

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small for gestational birth weight (SGA-dichotomous)	Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.	from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)
Secondary	Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.	Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum.	post partum