Placental Growth and Adverse Pregnancy Outcomes

Completed

• Conditions: Hypertension Induced by Pregnancy; Pre-Eclampsia; IUGR

• Registration Number: NCT01669525
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1043

Inclusion Criteria

• All singleton gestations presenting for Sequential Screen testing at HUP
• patients competent to provide verbal informed consent

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Small for gestational birth weight (SGA-dichotomous)	from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)	Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.

Secondary Outcome Measures

Name	Time	Method
Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.	post partum	Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum.

Trial Locations

Locations (1)

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States