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NCT Number: NCT06687239

Blind Measurement in Fetal Weight Estimation

Woman who are expected to give birth in the next 72 hours will be allocated randomly to a study group of blinded measurements for estimated fetal weight and a control group of non-blinded measurements. Accuracy of estimations will be compared between the groups.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Estimating fetal weight using ultrasound is an essential component in fetal medicine and prenatal treatment.

A study that was conducted as a part of the INTERGROWTH-21 project established international standards for fetal growth by documenting 3 measurements of biometry indices, which included head circumference, abdominal circumference, femur length and biparietal diameter (BPD). The measurements were not disclosed to the investigator in order to prevent bias.

In a recent study it was found that use of the average of the 3 biometric measurements compared with a single measurement for the purposes of estimating fetal weight, is more accurate. However, the measurements were disclosed to the investigator.

Currently, no studies have examined whether there blinded measurements are significantly better than non-blinded measurements.

The aim of this study is to compare blinded to non-blinded biometric measurements for estimation of fetal weight.

Woman who are expected to give birth in the next 72 hours will be asked to participate in the study. After singing an informed consent, participants will be randomly allocated to a study group of blinded measurements for estimated fetal weight and a control group of non-blinded measurements. Estimation of fetal weight will be performed using the Hadlock-4 formula in triplicate measurements. In the study group the measurement will be blinded from the sonographer and measurements will be revealed only upon completion of all measurements. In the control group, the same measurements will be conducted without blinding of the measurements during the assessment. Accuracy of estimations will be compared between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy
  • Gestational age between 37 and 41 weeks
  • Expected delivery within 72 hours

Exclusion criteria

  • Major Malformations
  • Active labor

Treatment and study plan

Blinded estimation of fetal weight

Diagnostic Test

Blinded ultrasound-based estimation of fetal weight

Non blinded estimation of fetal weight

Diagnostic Test

Non-blinded ultrasound-based estimation of fetal weight

Primary outcomes

  1. Estimated fetal weight accuracy

    Time frame: From estimation of fetal weight to delivery, up to 72 hours.

    Accuracy of fetal weight estimation. A continuous variable, measured as the absolute difference between birthweight and estimated fetal weight in grams.

Study contacts

Contact information is provided by the study sponsor or research team.

Eran Barzilay

CONTACT

[email protected]

+972-54-5409091

Sponsors and collaborators

Lead sponsor

Eran Brazilay, MD PhD

Other

Registry information

Official study title

Does Blind Measurement of Biometric Indices Improve the Accuracy of Fetal Weight Estimation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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