Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy

July 10, 2017 updated by: Doaa Shafie Belal, Cairo University

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

Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Greater Cairo
      • Cairo, Greater Cairo, Egypt, 11956
        • Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant females 32 weeks gestation or more with pre-eclampsia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-Eclampsia
pregnant women with Pre-Eclampsia will be assessed by serum antibodies and Doppler
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
It will be calculated after 1 year from the start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Doaa Sh Belal, MD, cairo U

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

July 30, 2018

Study Completion (Anticipated)

August 30, 2018

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3650

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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