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Completed

NCT Number: NCT01669525

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.

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Key information

Conditions

Hypertension Induced by Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced IUGR Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Small for gestational birth weight (SGA-dichotomous)

    Time frame: 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 outcomes

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

    Time frame: post partum

    Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2012
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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