Blind Measurement in Fetal Weight Estimation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Blinded estimation of fetal weight, Non blinded estimation of fetal weight.
- Кому может быть актуально
- Состояния в реестре: Pregnancy. Базовые параметры: 18 лет — 45 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Does Blind Measurement of Biometric Indices Improve the Accuracy of Fetal Weight Estimation
Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест Blinded estimation of fetal weight
Blinded ultrasound-based estimation of fetal weight - Диагностический тест Non blinded estimation of fetal weight
Non-blinded ultrasound-based estimation of fetal weight
Первичные конечные точки
- Estimated fetal weight accuracy [Срок оценки: From estimation of fetal weight to delivery, up to 72 hours.]
Критерии участия
Критерии включения
- Singleton pregnancy
- Gestational age between 37 and 41 weeks
- Expected delivery within 72 hours
Критерии исключения
- Major Malformations
- Active labor
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- 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
Идентификаторы
NCT: NCT06687239 · 0081-23-AAA