First Trimester Prediction of Preeclampsia and Fetal Growth Restriction

First Trimester Prediction of Preeclampsia and Fetal Growth Restriction Using Uterine Artery Doppler, Maternal Blood Pressure, Maternal Characteristics, Placental Volume and Maternal Serum Factors

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia; Fetal Growth Restriction

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 Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Miami Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All pregnant patients during their first trimester

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of Preeclampsia	During the first trimester (11-13+6 weeks)

Collaborators and Investigators

• Sponsor: Fetal Medicine Foundation
• Collaborators: Wright State University
• Investigators: Principal Investigator: Jiri D Sonek, MD, Fetal Medicine Foundation/USA

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Growth Disorders; Pre-Eclampsia; Fetal Growth Retardation
• Other Study ID Numbers: SC#5031