Placental Growth and Adverse Pregnancy Outcomes

July 17, 2017 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1043

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Singleton pregnancies presenting for Sequential Screen prior to 14 weeks gestation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No treatment
Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Nadav Schwartz, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (Estimate)

August 21, 2012

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 811129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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