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First Trimester Prediction of Preeclampsia and Fetal Growth Restriction

NCT ID: NCT02379494

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preeclampsia Fetal Growth Restriction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wright State University

OTHER

Sponsor Role collaborator

Fetal Medicine Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiri D Sonek, MD

Role: PRINCIPAL_INVESTIGATOR

Fetal Medicine Foundation/USA

Locations

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Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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SC#5031

Identifier Type: -

Identifier Source: org_study_id

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