A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening

Hillier, Teresa A.; Pedula, Kathryn L.; Ogasawara, Keith K.; Vesco, Kimberly K.; Oshiro, Caryn; Lubarsky, Suzanne L.; Marter, Jan Van

doi:10.1056/nejmoa2026028

Cited by 197 publications

(193 citation statements)

References 31 publications

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“…The study by Hillier et al [1] was designed and conducted as a "pragmatic RCT." The major advantages of this approach were that the study was integrated into standard care across the two Kaiser Permanente health systems involved and recruited a very substantial number of women (23 792 randomized).…”

Section: Considerations Regarding the Hillier Et Al [1] Trial Protocol And Resultsmentioning

confidence: 99%

“…Considering the study results as published [1], we note that overall, 16.5% of women were classified as GDM with the one-step IADPSG approach compared to 8.5% with the two-step USA approach [3]. Thus, in each group, approximately 83.5% received no GDM treatment and 8.5% received GDM treatment, irrespective of randomization.…”

Section: Accepted Articlementioning

confidence: 96%

“…The publication by Hillier et al [1] focused primarily on USA-based clinical practice for GDM management and included predominantly white and Asian women. However, the issues related to GDM diagnosis are even more pressing on a global scale, especially in low-and middle-income countries (LMICs) [6].…”

Section: Accepted Articlementioning

confidence: 99%

“…The optimal process for detecting and treating gestational diabetes mellitus (GDM) remains controversial, with wide variances in practice within and between countries. A recent pragmatic randomized controlled trial (RCT) undertaken by Hillier et al [1] in the USA has raised renewed worldwide interest in and discussion of GDM diagnosis. The study reported no benefit at a population level in frequency of large-for-gestational-age (LGA) infants, hypertensive disorders of pregnancy, primary cesarean delivery, or a predefined composite perinatal outcome using a "one-step" diagnostic process and diagnostic criteria (primary diagnostic 75 g oral glucose tolerance test [OGTT]) as suggested in 2010 by the International Association of Diabetes in Pregnancy Study Groups (IADPSG) [2] as compared to current dominant USA-based criteria [3], which employ a "two-step" process (initial nonfasting glucose challenge test [GCT] followed by a full OGTT if threshold glucose values are exceeded on the GCT).…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Update on diagnosis of hyperglycemia in pregnancy and gestational diabetes mellitus from FIGO’s Pregnancy & Non‐Communicable Diseases Committee

McIntyre

Oats

Kihara

et al. 2021

Intl J Gynecology & Obste

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The optimal process for detecting and treating gestational diabetes mellitus (GDM) remains controversial, with wide variances in practice within and between countries. A recent pragmatic randomized controlled trial (RCT) undertaken by Hillier et al. 1 in the USA has raised renewed worldwide interest in and discussion of GDM diagnosis.The study reported no benefit at a population level in frequency of large-for-gestational-age (LGA) infants, hypertensive disorders of pregnancy, primary cesarean delivery, or a predefined composite perinatal outcome using a "one-step" diagnostic process and diagnostic criteria (primary diagnostic 75 g oral glucose tolerance test [OGTT]) as suggested in 2010 by the International Association of Diabetes in Pregnancy Study Groups (IADPSG) 2 as compared to current dominant USA-based criteria, 3 which employ a "two-step" process (initial nonfasting glucose challenge test [GCT] followed by a full OGTT if threshold glucose values are exceeded on the GCT).It should be noted that the USA criteria use very similar OGTT diagnostic thresholds to the IADPSG criteria, but require two elevated values for a GDM diagnosis. This time-honored practice lies contrary to the large body of evidence, confirmed in a recent USA-based systematic review, demonstrating that women with one abnormal value on their diagnostic OGTT carry substantially higher risks of LGA babies, cesarean delivery, pregnancy-induced hypertension, Apgar score <7, neonatal intensive care unit admission, and respiratory distress syndrome. 4 Since the IADPSG criteria classified 16.5% of women as GDM compared to an 8.5% frequency using the dominant USA criteria in the Hillier et al. study, 1 an accompanying editorial by Casey 5 concluded that the IADPSG approach offered "no apparent maternal or perinatal benefit overall." While we applaud the efforts of Hillier et al. 1 in conducting such an important study, we consider that the interpretation of the trial's results merits detailed scrutiny. | CONSIDERATIONS REGARDING THE HILLIER ET AL. 1 TRIAL PROTOCOL AND RESULTSThe study by Hillier et al. 1 was designed and conducted as a "pragmatic RCT." The major advantages of this approach were that the study was integrated into standard care across the two Kaiser Permanente health systems involved and recruited a very substantial number of women (23 792 randomized). The investigators obtained

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Section: Considerations Regarding the Hillier Et Al [1] Trial Protocol And Resultsmentioning

confidence: 99%

Section: Accepted Articlementioning

confidence: 96%

Section: Accepted Articlementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Update on diagnosis of hyperglycemia in pregnancy and gestational diabetes mellitus from FIGO’s Pregnancy & Non‐Communicable Diseases Committee

McIntyre

Oats

Kihara

et al. 2021

Intl J Gynecology & Obste

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show abstract

“…More recently Hillier et al randomised 23,792 women to perform either the one step approach with diagnostic cut-off similar to the IADPSG or a two-step approach with 50 g GCT then a 100 g OGTT and concluded there were no significant between-group differences in perinatal and maternal outcomes. It is arguable that the study was sufficiently powered to detect true differences due to the low rate of reported perinatal and maternal outcomes [ 28 ]. Reviews on the use of a one-step two-hour OGTT have commented there is increased convenience but higher costs compared to the two-step approach with an initial GCT or a fasting glucose for diagnosis [ 29 , 30 ].…”

Section: Discussionmentioning

confidence: 99%

Comparison of Pregnancy Outcomes Using Different Gestational Diabetes Diagnostic Criteria and Treatment Thresholds in Multiethnic Communities between Two Tertiary Centres in Australian and New Zealand: Do They Make a Difference?

Yuen

Wong

Wolmarans

et al. 2021

IJERPH

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Introduction: Australia, but not New Zealand (NZ), has adopted the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria to diagnose gestational diabetes (GDM). We compared pregnancy outcomes using these different diagnostic approaches. Method: Prospective data of women with GDM were collected from one NZ (NZ) and one Australian (Aus) hospital between 2007–2018. Aus screening criteria with 2-step risk-based 50 g Glucose Challenge Testing (GCT) followed by 75 g-oral glucose tolerance testing (OGTT): fasting ≥ 5.5, 2-h ≥ 8.0 mmol/L (ADIPS98) changed to a universal OGTT and fasting ≥5.1, 1-h ≥ 10, 2-h ≥ 8.5 mmol/L (IADPSG). NZ used GCT followed by OGTT with fasting ≥ 5.5, 2-h ≥ 9.0 mmol/L (NZSSD); in 2015 adopted a booking HbA1c (NZMOH). Primary outcome was a composite of macrosomia, perinatal death, preterm delivery, neonatal hypoglycaemia, and phototherapy. An Aus subset positive using NZSSD was also defined. RESULTS: The composite outcome odds ratio compared to IADPSG (1788 pregnancies) was higher for NZMOH (934 pregnancies) 2.227 (95%CI: 1.84–2.68), NZSSD (1344 pregnancies) 2.19 (1.83–2.61), and ADIPS98 (3452 pregnancies) 1.91 (1.66–2.20). Composite outcomes were similar between the Aus subset and NZ. Conclusions: The IADPSG diagnostic criteria were associated with the lowest rate of composite outcomes. Earlier NZ screening with HbA1c was not associated with a change in adverse pregnancy outcomes.

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Screening for Gestational Diabetes

Pillay

Donovan

Guitard

et al. 2021

JAMA

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STUDY SELECTION English-language intervention studies for screening and treatment; observational studies on screening; prospective studies on screening test accuracy. DATA EXTRACTION AND SYNTHESISDual review of titles/abstracts, full-text articles, and study quality. Single-reviewer data abstraction with verification. Random-effects meta-analysis or bivariate analysis (accuracy).MAIN OUTCOMES AND MEASURES Pregnancy, fetal/neonatal, and long-term health outcomes; harms of screening; accuracy. RESULTS A total of 76 studies were included (18 randomized clinical trials [RCTs] [n = 31 241], 2 nonrandomized intervention studies [n = 190], 56 observational studies [n = 261 678]). Direct evidence on benefits of screening vs no screening was limited to 4 observational studies with inconsistent findings and methodological limitations. Screening was not significantly associated with serious or long-term harm. In 5 RCTs (n = 25 772), 1-step (International Association of Diabetes and Pregnancy Study Group) vs 2-step (Carpenter and Coustan) screening was significantly associated with increased likelihood of gestational diabetes (11.5% vs 4.9%) but no improved health outcomes. At or after 24 weeks of gestation, oral glucose challenge tests with 140-and 135-mg/dL cutoffs had sensitivities of 82% and 93%, respectively, and specificities of 82% and 79%, respectively, against Carpenter and Coustan criteria, and a test with a 140-mg/dL cutoff had sensitivity of 85% and specificity of 81% against the National Diabetes Group Data criteria. Fasting plasma glucose tests with cutoffs of 85 and 90 mg/dL had sensitivities of 88% and 81% and specificities of 73% and 82%, respectively, against Carpenter and Coustan criteria. Based on 8 RCTs and 1 nonrandomized study (n = 3982), treatment was significantly associated with decreased risk of primary cesarean deliveries (relative risk [RR]

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A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening

Cited by 197 publications

References 31 publications

Update on diagnosis of hyperglycemia in pregnancy and gestational diabetes mellitus from FIGO’s Pregnancy & Non‐Communicable Diseases Committee

Update on diagnosis of hyperglycemia in pregnancy and gestational diabetes mellitus from FIGO’s Pregnancy & Non‐Communicable Diseases Committee

Comparison of Pregnancy Outcomes Using Different Gestational Diabetes Diagnostic Criteria and Treatment Thresholds in Multiethnic Communities between Two Tertiary Centres in Australian and New Zealand: Do They Make a Difference?

Screening for Gestational Diabetes

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