Optical Coherence Tomography Angiography Compared to Maternal Doppler in Screening for Hypertension in Pregnancy

April 8, 2022 updated by: Mohamed Esmail Khalil Esmail, Minia University

Retinal Microvascular Changes by Optical Coherence Tomography Angiography Compared to Maternal Uterine Artry Doppler in Screening for Hypertensive Disorders in High-risk Pregnancies

Pregnancy related hypertension is one of the most prevalent obstetric complications. The aim of the study is to evaluate the validity and sensitivity of OCT angiography in prediction of pregnancy induced hypertensive disorders in comparison to maternal doppler in the first and second trimesters of pregnancy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
    • Minia Governorate
      • Minya, Minia Governorate, Egypt, 61111
        • Recruiting
        • Minia University
        • Contact:
        • Principal Investigator:
          • Mohamed EK Esmail, MD
        • Sub-Investigator:
          • Kareem Shaheen, MD
        • Principal Investigator:
          • Heba R AttaAllah, MD

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

22 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

two groups according to the risk of developing hypertension during pregnancy

Description

Inclusion Criteria:

  • Pregnant women in the first and second trimesters

Exclusion Criteria:

  • pregnant females with associated systemic vascular disease as diabetes, SLE

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
Diagnostic test: Optical coherence Tomography Angiography, Uterine artry doppler
vascular changes in retina by OCT angiography and uterine artry doppler in the first and second trimesters
case group
Diagnostic test: Optical coherence Tomography Angiography, Uterine artry doppler
vascular changes in retina by OCT angiography and uterine artry doppler in the first and second trimesters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
validity and sensitivity of OCT angiography
Time Frame: 6 months
sensitivity of OCTA in comparison to doppler in prediction of pregnancy related hypertension
6 months

Collaborators and Investigators

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

Sponsor

Minia University

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 (Actual)

April 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 294-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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