Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia

August 11, 2021 updated by: Sherif Elsirgany, National Research Centre, Egypt
• Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery >34 weeks) is more frequent and less serious than early preeclampsia (with delivery <34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • The introduction of three-dimensional (3D) ultrasound techniques, with the option of calculating placental volume and measuring vascular indices, has created an excellent opportunity to study early changes in the uteroplacental circulation space, which includes the maternal spiral arteries and the intervillous space. This technology may allow a more direct evaluation of the abnormal placentation process thought to herald the development of preeclampsia.
  • The aim of this study was to assess the usefulness of placental volume and 3D vascular indices as reliable predictors of early preeclampsia in comparison to uterine artery Doppler

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 1234
        • Recruiting
        • National Research Centre
        • Contact:

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 to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All pregnant women will be examined for antenatal care in the outpatient clinic and fetal medicine unit of obstetrics and gynecology department then they will be divided into two groups control and high risk

Description

Inclusion Criteria:

  • A. Control group: Pregnant women:

    1. Age between 18-35 years
    2. Parity: primigravidas and multiparas.
    3. Have no history of preeclampsia or eclampsia.
    4. Have no history of chronic hypertension.
    5. Not diabetic.
    6. Not have antiphospholipid syndrome.
    7. Not have autoimmune disease such as SLE.

B. High risk group: Pregnant women with:

  1. History of preeclampsia -Eclapmsia
  2. Chronic hypertension
  3. Diabetic
  4. Antiphospholipid syndrome.
  5. Autoimmune syndrome such as SLE.

Exclusion Criteria:

  • • Smoking

    • Dichorionic placentae
    • Fetal anomaly
    • Uterine fibroid at the site of placental implantation
    • Subchorionic hematoma

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group

Pregnant women:

  1. Age between 18-35 years
  2. Parity: primigravidas and multiparas.
  3. Have no history of preeclampsia or eclampsia.
  4. Have no history of chronic hypertension.
  5. Not diabetic.
  6. Not have antiphospholipid syndrome.
  7. Not have autoimmune disease such as SLE
Device: ultrasound machine
Ultrasound machine with a vocal software
High risk group

Pregnant women with:

  1. History of preeclampsia -Eclapmsia
  2. Chronic hypertension
  3. Diabetic
  4. Antiphospholipid syndrome.
  5. Autoimmune syndrome such as SLE.
Device: ultrasound machine
Ultrasound machine with a vocal software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
placental vascular indices in prediction of preeclampsia
Time Frame: one year
placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia
one year

Collaborators and Investigators

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

Sponsor

National Research Centre, Egypt

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)

June 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

February 3, 2019

First Submitted That Met QC Criteria

February 10, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • placental vascular indices

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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