Cross Sectional Area of Umbilical Cord Versus Hadlock's Formula in Prediction of Neonatal Birth Weight

May 3, 2022 updated by: Mena shafeek Ibrahim ghaly, Ain Shams University

Comparison of the Efficacy Between Ultrasound Measurement of Cross Sectional Area of the Umbilical Cord and Hadlock's Formula in Prediction of Neonatal Birth Weight at Term Gestation:Cross Sectional Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11511
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women at term gestation admitted at labor room or prepared for cesarean section

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cross sectional area of umbilical cord and Hadlock's formula
Ultrasound measurement of cross sectional area of umbilical cord within 1 cm from the umbilical cord insertion into the fetal abdomen And Fetal biometry using the standard Hadlock's formula
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1st hour of delivary
correlation with actual birth weight measured
1st hour of delivary

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2021

Primary Completion (ACTUAL)

April 15, 2022

Study Completion (ACTUAL)

April 15, 2022

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

May 3, 2022

First Posted (ACTUAL)

May 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ain Shams University Hos

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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