NCT02379494

Brief Summary

To evaluate the feasibility of screening for preeclampsia and fetal growth restriction between 11-13+6 weeks' gestation utilizing the combination of uterine artery doppler, maternal blood pressure, maternal characteristics, placental volume, and maternal serum factors, including PAPPA-A, PLGF, AFP and free Beta HCG. This is a non interventional study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
1 year until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

February 1, 2016

Enrollment Period

3.8 years

First QC Date

February 20, 2014

Last Update Submit

August 18, 2017

Conditions

PreeclampsiaFetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • Development of Preeclampsia

    During the first trimester (11-13+6 weeks)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All pregnant patients during their first trimester

You may qualify if:

  • All patients during their first trimester visit

You may not qualify if:

  • Fetal anomalies Pregnancies ending in termination, miscarriage or fetal death prior to 22 weeks and cases with no pregnancy follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A 5cc maternal blood sample will be obtained through standard blood draw. The blood will first be transferred onto a dry blood requisition form card. The blood sample will be refrigerated and the serum and dried blood spot samples will be sent to Perkin Elmer Laboratories (see attachment C for collection protocols). The maternal serum levels of PAPP-A, PLGF, AFP, and free β hCG will be measured according to a protocol established by Perkin Elmer Laboratories.

MeSH Terms

Conditions

Pre-EclampsiaFetal Growth Retardation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jiri D Sonek, MD

    Fetal Medicine Foundation/USA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 20, 2014

First Posted

March 5, 2015

Study Start

March 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 22, 2017

Record last verified: 2016-02

Locations

US(1)