PregnancyNCT06687239
Blind Measurement in Fetal Weight Estimation
A study testing Blinded estimation of fetal weight and Non blinded estimation of fetal weight in people with Pregnancy, run by Eran Brazilay, MD PhD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Blinded estimation of fetal weight and Non blinded estimation of fetal weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Gestational age between 37 and 41 weeks
- Expected delivery within 72 hours
Who cannot join
- Major Malformations
- Active labor
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Does Blind Measurement of Biometric Indices Improve the Accuracy of 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Blinded estimation of fetal weight, Non blinded estimation of fetal weight
- Keywords
- estimated fetal weight, Blinded measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded estimation of fetal weightDiagnostic test
Blinded ultrasound-based estimation of fetal weight
Non blinded estimation of fetal weightDiagnostic test
Non-blinded ultrasound-based estimation of fetal weight
| Study group | Role | What they receive |
|---|---|---|
| Blinded | Other | Blinded biometric measurements Receives: Diagnostic Test: Blinded estimation of fetal weight |
| Non-blinded | Other | Non-blinded biometric measurements Receives: Diagnostic Test: Non blinded estimation of fetal weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From estimation of fetal weight to delivery, up to 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eran Brazilay, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eran Brazilay, MD PhD, Assuta Ashdod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687239
- Sponsor's protocol ID
- 0081-23-AAA
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPD will be shared upon reasonable request
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.
PubMed 39105327Papageorghiou 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.
PubMed 25209488Chang 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.
PubMed 8270670Hammami 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.
PubMed 29611251Perlow 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.
PubMed 8913978
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Blind Measurement of Biometric Indices Improve the Accuracy of Fetal Weight Estimation
- ClinicalTrials.gov ID
- NCT06687239
- Acronym / sponsor ID
- 0081-23-AAA
- Conditions
- Pregnancy
- Keywords
- estimated fetal weight, Blinded measurements
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eran Brazilay, MD PhDUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded | Other | Diagnostic Test: Blinded estimation of fetal weightBlinded biometric measurements |
| Non-blinded | Other | Diagnostic Test: Non blinded estimation of fetal weightNon-blinded biometric measurements |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Gestational age between 37 and 41 weeks
- Expected delivery within 72 hours
Key exclusion criteria (2 listed)
- Major Malformations
- Active labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinded estimation of fetal weightBlinded ultrasound-based estimation of fetal weight | Diagnostic test | Blinded |
| Non blinded estimation of fetal weightNon-blinded ultrasound-based estimation of fetal weight | Diagnostic test | Non-blinded |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Background: PubMed 39105327Sheiman 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.
- Background: PubMed 25209488Papageorghiou 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.
- Background: PubMed 8270670Chang 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.
- Background: PubMed 29611251Hammami 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.
- Background: PubMed 8913978Perlow 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.
- Individual participant dataSharing planned: Yes. Anonymized IPD will be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Blinded estimation of fetal weight and Non blinded estimation of fetal weight in people with Pregnancy, run by Eran Brazilay, MD PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eran Barzilay (+972-54-5409091, eranb@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated fetal weight accuracy (time frame: From estimation of fetal weight to delivery, up to 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06687239, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.