Blind Measurement in Fetal Weight Estimation

NCT06687239 | Not Yet Recruiting

• 1 other identifier: 0081-23-AAA
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pregnancy

Keywords

estimated fetal weight; Blinded measurements

Outcome Measures

Primary Outcomes (1)

• Estimated fetal weight accuracy

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

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

Study Arms (2)

Blinded

OTHER

Blinded biometric measurements

Diagnostic Test: Blinded estimation of fetal weight

Non-blinded

OTHER

Non-blinded biometric measurements

Diagnostic Test: Non blinded estimation of fetal weight

Interventions

Blinded estimation of fetal weight DIAGNOSTIC_TEST

Blinded ultrasound-based estimation of fetal weight

Blinded

Non blinded estimation of fetal weight DIAGNOSTIC_TEST

Non-blinded ultrasound-based estimation of fetal weight

Non-blinded

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Major Malformations
• Active labor

Sponsors & Collaborators

• Eran Brazilay, MD PhD: lead

Related Publications (5)

• 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 BACKGROUND

• 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 Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project. Lancet. 2014 Sep 6;384(9946):869-79. doi: 10.1016/S0140-6736(14)61490-2.

  PMID: 25209488 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Eran Barzilay

CONTACT

+972-54-5409091; eranb@assuta.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of OBGYN ultrasound unit

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 13, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share