Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03214393
Recruitment Status : Unknown
Verified July 2017 by Doaa Shafie Belal, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Doaa Shafie Belal, Cairo University

Tracking Information
First Submitted Date July 10, 2017
First Posted Date July 11, 2017
Last Update Posted Date July 11, 2017
Estimated Study Start Date August 1, 2017
Estimated Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2017)
percentage of cases that develop severe pre-eclampsia [ Time Frame: It will be calculated after 1 year from the start of the study ]
percentage of cases that develop severe pre-eclampsia will be assessed by an investigator
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 Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy
Official Title Role of Maternal Anticardiolipin and Anti-B2 Glycoprotein I Antibodies in Correlation With Fetal Doppler in Prediction of Adverse Pregnancy Outcome in Patients With Preeclampsia
Brief Summary Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.
Detailed Description Assessment will be done for maternal serum anti-beta 2 glycoprotein 1 antibodies and anticardiolipin antibodies in cases of preeclampsia after 32 weeks of pregnancy. In addition, fetal Doppler changes will be assessed.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant females 32 weeks gestation or more with pre-eclampsia
Condition Pre-Eclampsia
Intervention
  • Diagnostic Test: Doppler
    Doppler will be done to pregnant women with Pre-Eclampsia
  • Diagnostic Test: serum antibodies
    serum antibodies will be measured for pregnant women with Pre-Eclampsia
Study Groups/Cohorts Pre-Eclampsia
pregnant women with Pre-Eclampsia will be assessed by serum antibodies and Doppler
Interventions:
  • Diagnostic Test: Doppler
  • Diagnostic Test: serum antibodies
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 Unknown status
Estimated Enrollment
 (submitted: July 10, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 30, 2018
Estimated Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Pregnant women 32 weeks or more gestational age
  • Pre-eclampsia
  • Singleton pregnancy

Exclusion Criteria:

  • Intrauterine fetal death
  • Fetus with apparent congenital anomalies
  • Pregnant females with other medical disorders
  • History of essential hypertension.
  • History of antepartum hemorrhage.
  • History of rupture of membranes.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03214393
Other Study ID Numbers 3650
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 Not Provided
Responsible Party Doaa Shafie Belal, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators
Principal Investigator: Doaa Sh Belal, MD Cairo U
PRS Account Cairo University
Verification Date July 2017