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PhenX Toolkit Supplemental Information Domain: Pregnancy Release Date: April 11, 2017 [International Fetal Growth Standards] About the Measure Domain Pregnancy Measure International Fetal Growth Standards Definition This measure includes abstraction of fetal growth and ultrasound information from a medical record. About the Protocol Description of Protocol Determination of fetal growth is a three-step process: Step 1: Ascertainment of Estimated Fetal Weight (EFW) Step 2: Verification of Gestational Age (GA) at which the EFW was recorded Step 3: Determination of EFW or biometry percentiles by plotting the EFW or relevant biometric measures at the appropriate GA on a predefined fetal growth curve. Protocol Text 1. Ascertainment of Estimated Fetal Weight (EFW) The investigator is encouraged to utilize one of the following approaches for documentation of EFW. Approach (a) is the preferred approach for retrospective studies, although it is recognized that biometric data may be less easily accessible in retrospective investigations, and as such approach (b) is provided as an alternative. (a) EFW (preferably in grams) derived by review of available ultrasound reports to obtain relevant biometric measures (bi-parietal diameter [BPD], head circumference [HC], abdominal circumference [AC], and femur length [FL]), followed by calculation of EFW from formula provided by Hadlock*. Date of ultrasound: ____________________ (DD/MMM/YYYY) Gestational Age: ________ weeks ________ days (as per protocol for GA) Biometric measures as they appear on the ultrasound report: Bi-parietal diameter (BPD): __________ mm Head circumference (HC): ___________ mm Abdominal circumference (AC): ___________ mm Femur length (FL): ___________ mm Estimated Fetal Weight (EFW): ________________ grams (b) EFW (preferably in grams) abstracted from ultrasound report contained within the medical record: PhenX Toolkit Supplemental Information [International Fetal Growth Standards] PhenX Toolkit Supplemental Information Domain: Pregnancy Release Date: April 11, 2017 [International Fetal Growth Standards] Date of ultrasound: ____________________ (DD/MMM/YYYY) Gestational Age: ________ weeks ________ days (as per protocol for GA) Estimated Fetal Weight: ________________ grams 2. Verification of Gestational Age (GA) See the PhenX measure for Gestational Age – Medical Record Abstraction. It is considered essential for interpretation of this measure. 3. Plotting the EFW or Biometric Measures – International standards Determination of fetal growth should then be undertaken, by plotting EFW or biometric measures on a growth curve, allowing for determination of percentiles, by using the following protocol: INTERGROWTH-21st – Fetal Growth Longitudinal Study (FGLS) *An SR of 11 methods of EFW assessment did not identify a superior formula; given that Hadlock (1985) is the most widely used formula, it may provide the greatest degree of consistency across studies Once biometric measures and gestational age have been obtained using one of the approaches described, the investigator should consult the EFW centiles in the INTERGROWTH-21st Fetal Growth Standards Project. Participant Pregnant women Rationale for Inclusion in Supplemental Information The INTERGROWTH 21st Project investigators conducted a prospective population-based study in eight diverse locations to develop international fetal growth standards that are endorsed by the World Health Organization (WHO). The standards are based on the pooled data from those eight populations and do not represent the ethnic diversity of the U.S. Source Stirnemann, J., Villar, J., Salomon, L. J., Ohuma, E., Ruyan, P., Altman, D. G., Nosten, F., Craik, R., Munim, S., Cheikh Ismail, L., Barros, F. C., Lambert, A., Norris, S., Carvalho, M., Jaffer, Y. A., Noble, J. A., Bertino, E., Gravett, M. G., Purwar, M., Victora, C., Uauy, R., Bhutta, Z., Kennedy, S., Papageorghiou, A. T. (2016). International Estimated Fetal Weight Standards of the INTERGROWTH-21st Project. Ultrasound Obstet Gynecol. doi: 10.1002/uog.17347 Hadlock FP, Harrist RB, Sharman RS, Deter RL, Park SK. (1985). PhenX Toolkit Supplemental Information [International Fetal Growth Standards] PhenX Toolkit Supplemental Information Domain: Pregnancy Release Date: April 11, 2017 [International Fetal Growth Standards] Estimation of fetal weight using head, body and femur measurements - a prospective study. Am J Obstet Gynecol, 151:333-337. Language of Source English Personnel and Training Required Personnel who are trained in performing medical records review Equipment Needs None Protocol Type Medical Record Abstraction General References Anderson, N. H., et al. (2016). INTERGROWTH-21st vs customized birthweight standards for identification of perinatal mortality and morbidity. Am J Obstet Gynecol, 214(4): 509.e501-507. Bricker L, Neilson JP, Dowswell T. (2008). Routine ultrasound in late pregnancy (after 24 weeks’ gestation). Cochrane Database Syst Rev, 4: CD001451. Conde-Agudelo A, Papageorghiou AT, Kennedy SH, Villar J. (2013). Novel biomarkers for predicting intrauterine growth restriction: a systematic review and meta-analysis. BJOG, 120:681–94. Ioannou C, Talbot K, Ohuma E, et al. (2012). Systematic review of methodology used in ultrasound studies aimed at creating charts of fetal size. BJOG, 119:1425–39. Malone FD, Canick JA, et al. (2005). First- and Second-Trimester Evalution of Risk (FASTER) Research Consortium. First-trimester or second-trimester screening, or both, for Down’s Syndrome. N Engl J Med, 353(19):2001-11. Sylvan K, Ryding EL, Rydhstroem H. (2005). Routine ultrasound screening in the third trimester: a population-based study. Acta Obstet Gynecol Scand, 84: 1154–58. Process and Review The Expert Review Panel has not reviewed this measure yet. PhenX Toolkit Supplemental Information [International Fetal Growth Standards]