Blind Measurement in Fetal Weight Estimation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blinded estimation of fetal weight, Non blinded estimation of fetal weight.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does Blind Measurement of Biometric Indices Improve the Accuracy of Fetal Weight Estimation
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Blinded estimation of fetal weight
Blinded ultrasound-based estimation of fetal weight - Diagnostic test Non blinded estimation of fetal weight
Non-blinded ultrasound-based estimation of fetal weight
Primary outcome measures
- Estimated fetal weight accuracy [Time frame: From estimation of fetal weight to delivery, up to 72 hours.]
Eligibility criteria
Inclusion criteria
- Singleton pregnancy
- Gestational age between 37 and 41 weeks
- Expected delivery within 72 hours
Exclusion criteria
- Major Malformations
- Active labor
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Sheiman V, Frenkel A, Glick N, Tovbin J, Neeman O, Barzilay E. Ultrasonic Estimation of Fetal Weight: Are Averaged Triplicate Measurements More Accurate Than Single Measurements? J Ultrasound Med. 2024 Nov;43(11):2147-2152. doi: 10.1002/jum.16545. Epub 2024 Aug 6. PMID 39105327
- Papageorghiou AT, Ohuma EO, Altman DG, Todros T, Cheikh Ismail L, Lambert A, Jaffer YA, Bertino E, Gravett MG, Purwar M, Noble JA, Pang R, Victora CG, Barros FC, Carvalho M, Salomon LJ, Bhutta ZA, Kennedy SH, Villar J; International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st). International standards for fetal growth based on serial ultrasound measurements: the Feta PMID 25209488
- Chang TC, Robson SC, Spencer JA, Gallivan S. Ultrasonic fetal weight estimation: analysis of inter- and intra-observer variability. J Clin Ultrasound. 1993 Oct;21(8):515-9. doi: 10.1002/jcu.1870210808. PMID 8270670
- Hammami A, Mazer Zumaeta A, Syngelaki A, Akolekar R, Nicolaides KH. Ultrasonographic estimation of fetal weight: development of new model and assessment of performance of previous models. Ultrasound Obstet Gynecol. 2018 Jul;52(1):35-43. doi: 10.1002/uog.19066. Epub 2018 Jun 3. PMID 29611251
- Perlow JH, Wigton T, Hart J, Strassner HT, Nageotte MP, Wolk BM. Birth trauma. A five-year review of incidence and associated perinatal factors. J Reprod Med. 1996 Oct;41(10):754-60. PMID 8913978
Identifiers
NCT: NCT06687239 · 0081-23-AAA