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Prediction of Outcome in Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT03871764
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Olfat Nooh Riad Ali, Cairo University

Tracking Information
First Submitted Date March 8, 2019
First Posted Date March 12, 2019
Last Update Posted Date March 12, 2019
Actual Study Start Date December 1, 2015
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2019)
  • percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature [ Time Frame: within 12 wks from diagnosis of severe preeclampsia ]
    placental abruption, prematurity, IUGR
  • percentage of fetuses and neonates complicated with intrauterine fetal death or need admission to incubator [ Time Frame: from diagnosis of severe preeclampsia till one week after delivery ]
    IUFD, admission to neonatal IUC
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prediction of Outcome in Severe Preeclampsia
Official Title Relation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of Preeclampsia
Brief Summary this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes
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 [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration 7 Days
Biospecimen Retention:   Samples Without DNA
Description:
blood samples and placental pathology
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.
Condition
  • Leiden Factor V Deficiency,Preeclampsia
  • Doppler Examination
  • Palental Pathology
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2019)
100
Original Actual Enrollment Same as current
Actual Study Completion Date April 2017
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

-

Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03871764
Other Study ID Numbers 019002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Olfat Nooh Riad Ali, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators Not Provided
PRS Account Cairo University
Verification Date March 2019