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

NCT05362175 | Completed FDA Device

• 1 other identifier: Ain Shams University Hos
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Birth Weight; Fetal Body Weight

Keywords

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

Outcome Measures

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

  1st hour of delivary

Study Arms (1)

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

Obstetric ultrasound DEVICE

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

Cross sectional area of umbilical cord and Hadlock's formula

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Birth Weight; Fetal Weight

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mena Shafeek

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: May 5, 2022
• Study Start: July 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)