PhenX Toolkit:



|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 pre-defined fetal growth curve. |

|Protocol Text |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: |

| | |

| |Date of ultrasound: ____________________ (DD/MMM/YYYY) |

| |Gestational Age: ________ weeks ________ days (as per protocol for GA) |

| | |

| |Estimated Fetal Weight: ________________ grams |

| | |

| |Verification of Gestational Age (GA) |

| | |

| |See the PhenX measure for Gestational Age – Medical Record Abstraction. It is considered essential for |

| |interpretation of this measure. |

| | |

| |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 |The INTERGROWTH 21st Project investigators conducted a prospective population-based study in eight |

|Supplemental Information |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). 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. |

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