Prediction of Outcome in Severe Preeclampsia

Doppler Examination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871764
• Other study ID #: 019002
• Status: Completed
• Start date: December 1, 2015
• Est. completion date: April 2017

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Doppler Examination
• Leiden Factor V Deficiency,Preeclampsia
• Palental Pathology
• Pre-Eclampsia

Intervention

Diagnostic Test:
• blood sample , doppler of uterine vessel and placenta
blood sample for factor V and doppler examination of uterine arteries , placenta pathology post partum

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature	placental abruption, prematurity, IUGR	within 12 wks from diagnosis of severe preeclampsia
Primary	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