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First Trimester Prediction of Preeclampsia and Fetal Growth Restriction

Sponsor
Fetal Medicine Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT02379494
Collaborator
Wright State University (Other)
1,200
Enrollment
1
Location
46.1
Duration (Months)
26.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Preeclampsia (PE) is a condition which affects approximately 2% of all pregnancies and can be a major cause of maternal and perinatal morbidity/mortality (2). The suspected underlying mechanism of PE is thought to be impaired trophoblastic invasion of the maternal spiral arteries leading to impaired placental perfusion, placental ischemia and subsequent development of endothelial dysfunction (3). There is evidence that PE, which is commonly associated with fetal growth restriction, can be predicted effectively at 11-13 weeks gestational age by combined screening algorithms combining uterine artery pulsatility index (PI), maternal mean arterial pressure (MAP) and maternal serum concentrations of placental products including but not limited to plasma protein A (PAPP-A), and placental growth factor (PLGF) (4-6).

    Aim of Study/Hypothesis:

    The aim of this study is to develop an algorithm based on the combination of maternal factors, uterine artery pulsatility index, mean arterial pressure, placental volume and serum biomarkers to estimate patient specific risks for the development of Preeclampsia in a US population.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    First Trimester Prediction of Preeclampsia and Fetal Growth Restriction Using Uterine Artery Doppler, Maternal Blood Pressure, Maternal Characteristics, Placental Volume and Maternal Serum Factors
    Study Start Date :
    Mar 1, 2013
    Actual Primary Completion Date :
    Jan 1, 2017
    Actual Study Completion Date :
    Jan 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Development of Preeclampsia [During the first trimester (11-13+6 weeks)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    All patients during their first trimester visit

    Exclusion Criteria:

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Miami Valley Hospital Dayton Ohio United States 45409

    Sponsors and Collaborators

    • Fetal Medicine Foundation
    • Wright State University

    Investigators

    • Principal Investigator: Jiri D Sonek, MD, Fetal Medicine Foundation/USA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fetal Medicine Foundation
    ClinicalTrials.gov Identifier:
    NCT02379494
    Other Study ID Numbers:
    • SC#5031
    First Posted:
    Mar 5, 2015
    Last Update Posted:
    Aug 22, 2017
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Fetal Growth Retardation

    Study Results

    No Results Posted as of Aug 22, 2017