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

NCT04240041 | Unknown

• 1 other identifier: TCD/PT-GA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Age and Weight Conditions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pregnant women at 32-36 weeks gestational age

Pregnant women at 32-36 weeks gestational age with sure dates and crown-rump length dating ultrasound

Diagnostic Test: Transcerebellar diamater; Diagnostic Test: Placental thickness

Interventions

Transcerebellar diamater DIAGNOSTIC_TEST

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.

Pregnant women at 32-36 weeks gestational age

Placental thickness DIAGNOSTIC_TEST

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

Pregnant women at 32-36 weeks gestational age

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Abbsia, 002, Egypt

RECRUITING

Study Officials

• Ayat Allah Mahmoud, MB BCh

  Resident of Obstetrics & Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayat Allah Mahmoud, MB BCh

CONTACT

01030717379; Drayaghoneim15@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of O&G

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: July 10, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)