Placental Growth and Adverse Pregnancy Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nadav Schwartz, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01669525
First received: August 15, 2012
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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
Hypertension Induced by Pregnancy
Pre-Eclampsia
IUGR

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Small for gestational birth weight (SGA-dichotomous) [ Time Frame: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks) ] [ Designated as safety issue: No ]
    Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.


Secondary Outcome Measures:
  • Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death. [ Time Frame: post partum ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: November 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation.

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.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nadav Schwartz, Assistant Professor of Obstetrics and Gynecology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01669525     History of Changes
Other Study ID Numbers: 811129
Study First Received: August 15, 2012
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014