Reference intervals for hemoglobin Alc in pregnant women: Data from an Italian multicenter study

Andrea Mosca, Renata Paleari, Maria G. Dalfrà, Graziano Di Cianni, Ilaria Cuccuru, Giovanni Pellegrini, Lucia Malloggi, Matteo Bonomo, Simona Granata, Ferruccio Ceriotti, Maria T. Castiglioni, Marco Songini, Giuliana Tocco, Michela Masin, Mario Plebani, Annunziata Lapolla

Research output: Contribution to journalArticle

Abstract

Background: The reference intervals for hemoglobin A1c (Hb A1c) in pregnant women without diabetes are not well defined, and few examples of reference intervals established by networks of different laboratories are available. Methods: Five Italian Diabetic Care Units were involved in the study. Data were collected from 445 pregnant women without diabetes, selected on the basis of glucose challenge test results, and from 384 nonpregnant control women. The Hb A1c measurements were performed with HPLC systems aligned to the Diabetes Control and Complications Trial. Plasma glucose measurements were also performed locally. Both Hb A1c and glucose measurements were harmonized by running appropriate external quality assessment schemes. The reference intervals were calculated in terms of nonparametric 2.5th to 97.5th percentiles with 0.90 confidence intervals. Results: The Hb A1c measurements were reproducible (CV = 2.0%) and accurate [mean (SE) difference from the target values, -0.10 (0.06)%]. Glucose measurements were also reproducible (mean CV = 3.2%) and accurate [difference from the target values, -0.01(0.04) mmol/L]. To calculate common reference intervals, we merged the data collected in the different centers. The Hb A 1c reference intervals were 4.0%-5.5% for pregnant nondiabetic women and 4.8%-6.2% for nonpregnant controls. Conclusions: Healthy pregnant women have lower Hb A1c concentrations than nonpregnant women. The reference intervals for Hb A1c in pregnant women should therefore be lower than those currently in use.

Original languageEnglish
Pages (from-to)1138-1143
Number of pages6
JournalClinical Chemistry
Volume52
Issue number6
DOIs
Publication statusPublished - Jun 2006

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Multicenter Studies
Pregnant Women
Hemoglobins
Medical problems
Glucose
Diabetes Complications
High Pressure Liquid Chromatography
Confidence Intervals
Plasmas

ASJC Scopus subject areas

  • Clinical Biochemistry

Cite this

Mosca, A., Paleari, R., Dalfrà, M. G., Di Cianni, G., Cuccuru, I., Pellegrini, G., ... Lapolla, A. (2006). Reference intervals for hemoglobin Alc in pregnant women: Data from an Italian multicenter study. Clinical Chemistry, 52(6), 1138-1143. https://doi.org/10.1373/clinchem.2005.064899

Reference intervals for hemoglobin Alc in pregnant women : Data from an Italian multicenter study. / Mosca, Andrea; Paleari, Renata; Dalfrà, Maria G.; Di Cianni, Graziano; Cuccuru, Ilaria; Pellegrini, Giovanni; Malloggi, Lucia; Bonomo, Matteo; Granata, Simona; Ceriotti, Ferruccio; Castiglioni, Maria T.; Songini, Marco; Tocco, Giuliana; Masin, Michela; Plebani, Mario; Lapolla, Annunziata.

In: Clinical Chemistry, Vol. 52, No. 6, 06.2006, p. 1138-1143.

Research output: Contribution to journalArticle

Mosca, A, Paleari, R, Dalfrà, MG, Di Cianni, G, Cuccuru, I, Pellegrini, G, Malloggi, L, Bonomo, M, Granata, S, Ceriotti, F, Castiglioni, MT, Songini, M, Tocco, G, Masin, M, Plebani, M & Lapolla, A 2006, 'Reference intervals for hemoglobin Alc in pregnant women: Data from an Italian multicenter study', Clinical Chemistry, vol. 52, no. 6, pp. 1138-1143. https://doi.org/10.1373/clinchem.2005.064899
Mosca A, Paleari R, Dalfrà MG, Di Cianni G, Cuccuru I, Pellegrini G et al. Reference intervals for hemoglobin Alc in pregnant women: Data from an Italian multicenter study. Clinical Chemistry. 2006 Jun;52(6):1138-1143. https://doi.org/10.1373/clinchem.2005.064899
Mosca, Andrea ; Paleari, Renata ; Dalfrà, Maria G. ; Di Cianni, Graziano ; Cuccuru, Ilaria ; Pellegrini, Giovanni ; Malloggi, Lucia ; Bonomo, Matteo ; Granata, Simona ; Ceriotti, Ferruccio ; Castiglioni, Maria T. ; Songini, Marco ; Tocco, Giuliana ; Masin, Michela ; Plebani, Mario ; Lapolla, Annunziata. / Reference intervals for hemoglobin Alc in pregnant women : Data from an Italian multicenter study. In: Clinical Chemistry. 2006 ; Vol. 52, No. 6. pp. 1138-1143.
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abstract = "Background: The reference intervals for hemoglobin A1c (Hb A1c) in pregnant women without diabetes are not well defined, and few examples of reference intervals established by networks of different laboratories are available. Methods: Five Italian Diabetic Care Units were involved in the study. Data were collected from 445 pregnant women without diabetes, selected on the basis of glucose challenge test results, and from 384 nonpregnant control women. The Hb A1c measurements were performed with HPLC systems aligned to the Diabetes Control and Complications Trial. Plasma glucose measurements were also performed locally. Both Hb A1c and glucose measurements were harmonized by running appropriate external quality assessment schemes. The reference intervals were calculated in terms of nonparametric 2.5th to 97.5th percentiles with 0.90 confidence intervals. Results: The Hb A1c measurements were reproducible (CV = 2.0{\%}) and accurate [mean (SE) difference from the target values, -0.10 (0.06){\%}]. Glucose measurements were also reproducible (mean CV = 3.2{\%}) and accurate [difference from the target values, -0.01(0.04) mmol/L]. To calculate common reference intervals, we merged the data collected in the different centers. The Hb A 1c reference intervals were 4.0{\%}-5.5{\%} for pregnant nondiabetic women and 4.8{\%}-6.2{\%} for nonpregnant controls. Conclusions: Healthy pregnant women have lower Hb A1c concentrations than nonpregnant women. The reference intervals for Hb A1c in pregnant women should therefore be lower than those currently in use.",
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T2 - Data from an Italian multicenter study

AU - Mosca, Andrea

AU - Paleari, Renata

AU - Dalfrà, Maria G.

AU - Di Cianni, Graziano

AU - Cuccuru, Ilaria

AU - Pellegrini, Giovanni

AU - Malloggi, Lucia

AU - Bonomo, Matteo

AU - Granata, Simona

AU - Ceriotti, Ferruccio

AU - Castiglioni, Maria T.

AU - Songini, Marco

AU - Tocco, Giuliana

AU - Masin, Michela

AU - Plebani, Mario

AU - Lapolla, Annunziata

PY - 2006/6

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N2 - Background: The reference intervals for hemoglobin A1c (Hb A1c) in pregnant women without diabetes are not well defined, and few examples of reference intervals established by networks of different laboratories are available. Methods: Five Italian Diabetic Care Units were involved in the study. Data were collected from 445 pregnant women without diabetes, selected on the basis of glucose challenge test results, and from 384 nonpregnant control women. The Hb A1c measurements were performed with HPLC systems aligned to the Diabetes Control and Complications Trial. Plasma glucose measurements were also performed locally. Both Hb A1c and glucose measurements were harmonized by running appropriate external quality assessment schemes. The reference intervals were calculated in terms of nonparametric 2.5th to 97.5th percentiles with 0.90 confidence intervals. Results: The Hb A1c measurements were reproducible (CV = 2.0%) and accurate [mean (SE) difference from the target values, -0.10 (0.06)%]. Glucose measurements were also reproducible (mean CV = 3.2%) and accurate [difference from the target values, -0.01(0.04) mmol/L]. To calculate common reference intervals, we merged the data collected in the different centers. The Hb A 1c reference intervals were 4.0%-5.5% for pregnant nondiabetic women and 4.8%-6.2% for nonpregnant controls. Conclusions: Healthy pregnant women have lower Hb A1c concentrations than nonpregnant women. The reference intervals for Hb A1c in pregnant women should therefore be lower than those currently in use.

AB - Background: The reference intervals for hemoglobin A1c (Hb A1c) in pregnant women without diabetes are not well defined, and few examples of reference intervals established by networks of different laboratories are available. Methods: Five Italian Diabetic Care Units were involved in the study. Data were collected from 445 pregnant women without diabetes, selected on the basis of glucose challenge test results, and from 384 nonpregnant control women. The Hb A1c measurements were performed with HPLC systems aligned to the Diabetes Control and Complications Trial. Plasma glucose measurements were also performed locally. Both Hb A1c and glucose measurements were harmonized by running appropriate external quality assessment schemes. The reference intervals were calculated in terms of nonparametric 2.5th to 97.5th percentiles with 0.90 confidence intervals. Results: The Hb A1c measurements were reproducible (CV = 2.0%) and accurate [mean (SE) difference from the target values, -0.10 (0.06)%]. Glucose measurements were also reproducible (mean CV = 3.2%) and accurate [difference from the target values, -0.01(0.04) mmol/L]. To calculate common reference intervals, we merged the data collected in the different centers. The Hb A 1c reference intervals were 4.0%-5.5% for pregnant nondiabetic women and 4.8%-6.2% for nonpregnant controls. Conclusions: Healthy pregnant women have lower Hb A1c concentrations than nonpregnant women. The reference intervals for Hb A1c in pregnant women should therefore be lower than those currently in use.

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