Placental Growth and Adverse Pregnancy Outcomes

NCT ID: NCT01669525

Last Updated: 2017-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1043 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Hypertension Induced by Pregnancy Pre-Eclampsia IUGR

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No treatment

Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadav Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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811129

Identifier Type: -

Identifier Source: org_study_id

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