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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03838887
• Other study ID #: placental vascular indices
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2021
• Source: National Research Centre, Egypt
• Contact: SHERIF MOHAMMED ELSIRGANY, DOCTOR
• Phone: +201223607191
• Email: SHERIFELSIRGANY[@]YAHOO.COM
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Device:
• ultrasound machine
Ultrasound machine with a vocal software

Locations

Country	Name	City	State
Egypt	National Research Centre	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	placental vascular indices in prediction of preeclampsia	placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia	one year