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Placental Growth and Adverse Pregnancy Outcomes

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ClinicalTrials.gov Identifier: NCT01669525
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Hypertension Induced by Pregnancy Pre-Eclampsia IUGR

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 Design

Study Type : Observational
Actual Enrollment : 1043 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome
Study Start Date : November 2009
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Maternal serum will be collected. Placental biopsies may be collected.

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Singleton pregnancies presenting for Sequential Screen prior to 14 weeks gestation
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669525


Locations
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Nadav Schwartz, MD University of Pennsylvania
More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01669525     History of Changes
Other Study ID Numbers: 811129
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Hypertension
Vascular Diseases
Cardiovascular Diseases