NCT01669525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,043

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

6.6 years

First QC Date

August 15, 2012

Last Update Submit

July 17, 2017

Conditions

Hypertension Induced by PregnancyPre-EclampsiaIUGR

Outcome Measures

Primary Outcomes (1)

  • Small for gestational birth weight (SGA-dichotomous)

    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 Outcomes (1)

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

    post partum

Study Arms (1)

No treatment

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

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Singleton pregnancies presenting for Sequential Screen prior to 14 weeks gestation

You may qualify if:

  • All singleton gestations presenting for Sequential Screen testing at HUP
  • patients competent to provide verbal informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal serum will be collected. Placental biopsies may be collected.

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Nadav Schwartz, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 21, 2012

Study Start

November 1, 2009

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations

US(1)