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Completed

NCT Number: NCT02379494

First Trimester Prediction of Preeclampsia and Fetal Growth Restriction

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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Key information

Conditions

Preeclampsia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Restriction Fetal Growth Retardation Growth Disorders Hypertension, Pregnancy-Induced Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Development of Preeclampsia

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

Sponsors and collaborators

Lead sponsor

Fetal Medicine Foundation

Other

Collaborators

  • Wright State University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 5, 2015
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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