Evidence map›Paper›PMID 36928064›Full record

Trial reportPloS one2023

A new method for customized fetal growth reference percentiles.

Katherine L Grantz, Stefanie N Hinkle, Dian He, John Owen, Daniel Skupski, Cuilin Zhang, Anindya Roy

Registry-linked trialFull text readClinical Trial
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00912132 (The National Standard for Normal Fetal Growth), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00912132 completednot on this map

The National Standard for Normal Fetal Growth

TypeobservationalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2009 to 2013Enrolled2,802ConditionsPregnancy, Fetal Growth
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Katherine L GrantzDivision of Population Health Research, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, United States of America.ORCID 0000-0003-0276-8534
Stefanie N HinkleDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.ORCID 0000-0003-4312-708X
Dian HeDivision of Population Health Research, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, United States of America.
John OwenDivision of Maternal and Fetal Medicine, Department of Obstetrics and Gynecology, Heersink School of Medicine, Birmingham, Alabama, United States of America.
Daniel SkupskiDepartment of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Weill Cornell Medicine and New York Presbyterian Queens, New York, New York, United States of America.ORCID 0000-0003-1504-0024
Cuilin ZhangDivision of Population Health Research, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, United States of America.
Anindya RoyDepartment of Mathematics and Statistics, University of Maryland Baltimore County, Baltimore, Maryland, United States of America.

Funding

NICHD NIH HHS HHSN267200603425CNICHD NIH HHS HHSN275200800002CNICHD NIH HHS HHSN275200800002INICHD NIH HHS HHSN275200800003CNICHD NIH HHS HHSN275200800003INICHD NIH HHS HHSN275200800012CNICHD NIH HHS HHSN275200800013CNICHD NIH HHS HHSN275200800014CNICHD NIH HHS HHSN275200800028CNICHD NIH HHS HHSN275201000009C
6 · The paper itself

Abstract

backgroundCustomized fetal growth charts assume birthweight at term to be normally distributed across the population with a constant coefficient of variation at earlier gestational ages. Thus, standard deviation used for computing percentiles (e.g., 10th, 90th) is assumed to be proportional to the customized mean, although this assumption has never been formally tested.

methodsIn a secondary analysis of NICHD Fetal Growth Studies-Singletons (12 U.S. sites, 2009-2013) using longitudinal sonographic biometric data (n = 2288 pregnancies), we investigated the assumptions of normality and constant coefficient of variation by examining behavior of the mean and standard deviation, computed following the Gardosi method. We then created a more flexible model that customizes both mean and standard deviation using heteroscedastic regression and calculated customized percentiles directly using quantile regression, with an application in a separate study of 102, 012 deliveries, 37-41 weeks.

resultsAnalysis of term optimal birthweight challenged assumptions of proportionality and that values were normally distributed: at different mean birthweight values, standard deviation did not change linearly with mean birthweight and the percentile computed with the normality assumption deviated from empirical percentiles. Composite neonatal morbidity and mortality rates in relation to birthweight < 10th were higher for heteroscedastic and quantile models (10.3% and 10.0%, respectively) than the Gardosi model (7.2%), although prediction performance was similar among all three (c-statistic 0.52-0.53).

conclusionsOur findings question normality and constant coefficient of variation assumptions of the Gardosi customization method. A heteroscedastic model captures unstable variance in customization characteristics which may improve detection of abnormal growth percentiles.

trial registrationClinicalTrials.gov identifier: NCT00912132.

Indexed as

Fetal DevelopmentPrenatal CareBirth WeightFemaleFetusGestational AgeHumansInfant, NewbornPregnancyReference ValuesUltrasonography, Prenatal

Identifiers

PMID36928064
PMCPMC10019672

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.