First Trimester Prediction of Preeclampsia and Fetal Growth Restriction

Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379494
• Other study ID #: SC#5031
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: August 18, 2017
• Start date: March 2013
• Est. completion date: January 1, 2017

Study information

• Verified date: February 2016
• Source: Fetal Medicine Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation
• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
United States	Miami Valley Hospital	Dayton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Fetal Medicine Foundation	Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Preeclampsia		During the first trimester (11-13+6 weeks)