Prediction of Outcome in Severe Preeclampsia

Relation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of Preeclampsia

this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes

Study Overview

• Status: Completed
• Conditions: Leiden Factor V Deficiency,Preeclampsia; Doppler Examination; Palental Pathology
• Intervention / Treatment: Diagnostic test: blood sample , doppler of uterine vessel and placenta

Detailed Description

leiden mutation is activated protein C resistance with hypercoagulable states and increased thrombotic risk. 99 % are heterozygous and 1 % is homozygous , very rare cases are psoudohomozygous with factor V deficiency. relation to this mutation was studied in severe preeclamptic patients. doppler indices of uterine arteries , increased pulsetility index or unilateral or bilateral uterine artery notch and placental pathology were studied.

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with preeclampsia in 3rd trimester. Singleton pregnancy. Accurate gestational age confirmed by last menstrual period or sonography before 20 weeks.

Description

Inclusion Criteria: severe preeclampsia in 3rd trimester -

Exclusion Criteria:Twin pregnancy. Fetal congenital anomalies. Diabetic patient, impaired renal function. Any medical disorders even that HTN. Any placental pathology,Autoimmune diseases. Women with uterine activity or clinical emergencies with maternal hemodynamic instability or an indication for immediate termination of pregnancy.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature	placental abruption, prematurity, IUGR	within 12 wks from diagnosis of severe preeclampsia
percentage of fetuses and neonates complicated with intrauterine fetal death or need admission to incubator	IUFD, admission to neonatal IUC	from diagnosis of severe preeclampsia till one week after delivery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2015
• Primary Completion (ACTUAL): September 30, 2016
• Study Completion (ACTUAL): April 1, 2017

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (ACTUAL): March 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Pregnancy Complications; Blood Coagulation Disorders; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Factor V Deficiency
• Other Study ID Numbers: 019002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No