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

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04240041

Collaborator

(none)

100

Enrollment

Location

11.7

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Age and Weight Conditions	Diagnostic Test: Transcerebellar diamater Diagnostic Test: Placental thickness

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jul 10, 2019

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 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. Diagnostic Test: 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

Arm

Intervention/Treatment

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

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.

Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

Concordance between estimated gestational age and combined transcerebellar diameter and placental thickness estimation [32-36 weeks gestational age]
Concordance between the estimated gestational age using last menstrual period and dating ultrasound; and that estimated using combination of transcerebellar diameter and placental thickness

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams Maternity Hospital	Cairo	Abbsia	Egypt	002

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Ayat Allah Mahmoud, MB BCh, Resident of Obstetrics & Gynecology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayatullah Abd ElFatah Mahmoud, Resident of O&G, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04240041

Other Study ID Numbers:

TCD/PT-GA

First Posted:

Jan 27, 2020

Last Update Posted:

Jan 27, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 27, 2020