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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05362175
Other study ID # Ain Shams University Hos
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2021
Est. completion date April 15, 2022

Study information

Verified date May 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ultrasound measurement of cross sectional area of umbilical cord might offer advantage over Hadlock's formula for accurate estimation of actual birth weight at term gestation leading to prevention of large number of maternal and neonatal morbidity and mortality.


Description:

Umbilical cord is a vital structure of maternal-fetal life that can be used to evaluate pregnancy outcomes. In the past, sonographic investigations of the umbilical cord were limited to identification of the number of vessels and Doppler evaluation of the blood flow. Various formulas have developed to calculate Estimated Fetal Weight (EFW) using fetal biometry. While it is being accurate to a degree, they are associated with error especially with extreme birth weight. In this study using the ultrasound to look for a relation between the umbilical cord cross sectional area and estimated birth weight, as it's easy to use and readily available, comparing the estimated birth weight obtained by this method with that of Hadlock's formula measures at term gestation. Trying to prove that the umbilical cord area formula might gave advocacy for future usage for birth weight prediction.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date April 15, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Pregnant women with: - Age: 18-35 years. - Singleton living fetus. - Term gestation (37wks_ 41wks+6days). (Spong , 2013). - Admitted at labor room or prepared for caesarean section Exclusion Criteria: - o Intrauterine Dead fetus (IUFD). - Structurally malformed fetus or umbilical cord (single umbilical artery; SUA). - Multiple pregnancies. - Oligohydraminos (AFI < 5cm or DVP <2 cm) or polyhydraminos (AFI > 25 cm or DVP > 8 cm) (Morteza et al., 2018). - Uterine fibroid. - Abnormal Doppler flowmetry of umbilical artery. - Maternal diseases (Diabetes mellitus, Hypertensive disorders, renal diseases, Ischemic heart diseases), history of drug intake (Antihypertensive, antiepileptic, oral hypoglycemic drugs).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Obstetric ultrasound
ultrasound measurement of the cross sectional area of umbilical cord within 1 cm from the cord insertion in to fetal abdomen and the standard Hadlock's formula

Locations

Country Name City State
Egypt Ain Shams university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimated fetal weight calculation by hadlock's formula and by umbilical cord cross sectional area ,then correlation with actual birth weight measured with in 1st hour of delivary correlation with actual birth weight measured 1st hour of delivary
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