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CompletedNCT05362175Updated May 5, 2022

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

An observational study in Birth Weight and Fetal Body Weight, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Birth Weight
  • Fetal Body Weight

Keywords

  • Birth weight
  • Hadlock's formula
  • Cross sectional area of umbilical cord
  • Umbilical cord
  • Fetal biometry
03

In context

Birth Weight

185 studies on the registry are indexed under Birth Weight; 25 are open to participants now.

This study's enrollment of 220 is close to the median of 240 across 63 observational studies indexed under Birth Weight.

Browse Birth Weight studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Device: Obstetric ultrasound

Interventions

  • DeviceObstetric 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1st hour of delivary

07

Study locations

1 site
  • Ain Shams university
    Cairo, 11511, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05362175
Responsible party
Mena shafeek Ibrahim ghaly (Mena Shafeek, Ain Shams University) — Principal investigator
First posted
May 5, 2022
Start date
Jul 15, 2021
Primary completion
Apr 15, 2022
Completion
Apr 15, 2022
Last update
May 5, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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