Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age

Gestational Age and Weight Conditions Clinical Trial

Official title:

Accuracy of Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age: Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240041
• Other study ID #: TCD/PT-GA
• Status: Recruiting
• Start date: July 10, 2019
• Est. completion date: July 2020

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: Ayat Allah Mahmoud, MB BCh
• Phone: 01030717379
• Email: Drayaghoneim15[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy will be recruited. Ultrasonographic estimation of gestational age using combined transcerebellar diameter and placental thickness will be compared to the actual estimated gestational age.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• Sure of dates

• Have dating ultrasound with crown rump length between (9 to 12 )weeks

• No hormonal contraception 3 months before conception.

• Regular menstrual cycles.

• Medically free.

• Single pregnancy

• Gestational age 32-36 weeks

Exclusion Criteria:

• Irregular menstrual cycles and not sure of dates

• Multiple pregnancy.

• Fetal anomalies.

• Placenta previa, placental anomalies and poor visualization of the placenta

• Fetal growth restriction

• Pregnant women with medical disorder e.g. diabetes mellitus, Pre-eclampsia, Systemic lupus erythromatosis, hypertension.

Related Conditions & MeSH terms

• Gestational Age and Weight Conditions

Intervention

Diagnostic Test:
• Transcerebellar diamater
Using SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, trans-cerebellar diameter is identified by obtaining an oblique view through posterior fossa that included visualization of midline thalamus, cerebellar hemispheres and cisterna magna.
• Placental thickness
Using SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, placental thickness will be measured at the level of the umbilical cord insertion excluding the myometrium and sub-placental veins

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo	Abbsia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between estimated gestational age and combined transcerebellar diameter and placental thickness estimation	Concordance between the estimated gestational age using last menstrual period and dating ultrasound; and that estimated using combination of transcerebellar diameter and placental thickness	32-36 weeks gestational age