Predictors of Intrauterine Growth Restriction

Pre-Eclampsia Clinical Trial

Official title:

Second Trimester Doppler Indices and Placental Vascularity as Predictors of Intrauterine Growth Restriction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03349671
• Other study ID #: IUGRPET
• Status: Not yet recruiting
• Start date: October 2018
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: Ahmed Abbas, MD
• Phone: 1001655790
• Email: bmr90[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible.

The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was employed whereby fetal biometry and placental location were detected. Later on, Doppler measurements & 3-dimensional (3D) representation became feasible further revolutionizing this area

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Pregnant female.

2. Pregnant ± 22 to 26 weeks gestation

3. Singleton pregnancy.

4. Consenting to participate

Exclusion Criteria:

1. Intrauterine fetal death

2. Diagnosed to have Any congenital anomalies

3. Symmetrical IUGR

4. Established fetal compromise that necessitates delivery

Related Conditions & MeSH terms

• Eclampsia
• Fetal Growth Retardation
• Pre-Eclampsia

Intervention

Procedure:
• ultrasound
A 3D volume of the uterus will be acquired by transabdominal sonography. The sweep angle was set at 85º and the probe will be kept perpendicular to the placental plate. The placenta will be examined and the size of the volume box will be adapted in such a way that the placenta fitted into it completely. The volume will then stored for later offline analysis.

Locations

Country	Name	City	State
Egypt	Assiut Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of preeclampsia during pregnancy.	number of women developed preeclampsia	5 months