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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03214393
Recruitment Status : Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
Doaa Shafie Belal, Cairo University

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

Condition or disease Intervention/treatment
Pre-Eclampsia Diagnostic Test: Doppler Diagnostic Test: serum antibodies

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant females 32 weeks gestation or more with pre-eclampsia

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03214393

Contact: Doaa Sh Belal, MD 0020223682030

Department of Obstetrics and Gynecology Not yet recruiting
Cairo, Greater Cairo, Egypt, 11956
Contact: Doaa Belal, MD    0020223682030   
Sponsors and Collaborators
Cairo University
Principal Investigator: Doaa Sh Belal, MD Cairo U

Responsible Party: Doaa Shafie Belal, Principal investigator, Cairo University Identifier: NCT03214393     History of Changes
Other Study ID Numbers: 3650
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Immunologic Factors
Physiological Effects of Drugs