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Cited by 78Gestational Diabetes Research and ManagementPregnancy and Medication ImpactDiabetes Management and Research

Perinatal Outcomes of Two Screening Strategies for Gestational Diabetes Mellitus: A Randomized Controlled Trial

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Davis, Esa M., Abebe, Kaleab Z., Simhan, Hyagriv N., Catalano, Patrick, Costacou, Tina, Comer, Diane, Orris, Steven, Ly, Kathleen +4 more·2021·Obstetrics & Gynecology
DOI 10.1097/aog.0000000000004431PMC PMC8288467
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Abstract

OBJECTIVE: To evaluate differences in short-term perinatal outcomes between the two prominent screening strategies for gestational diabetes mellitus, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and Carpenter-Coustan. METHODS: In this single-site, blinded, randomized, comparative effectiveness trial, participants received a nonfasting 50-g oral glucose tolerance test and, if less than 200 mg/dL (less than 11.1 mmol/L), were randomized to further screening with either IADPSG or Carpenter-Coustan criteria. Gestational diabetes treatment occurred per routine clinical care. The primary outcome was incidence of large-for-gestational-age (LGA) neonates. Prespecified secondary outcomes included small-for-gestational-age (SGA) neonates, cesarean birth, and neonatal and maternal composites of adverse perinatal outcomes. Assuming a 15% incidence of LGA neonates in the Carpenter-Coustan group, 782 participants provided more than 80% power to detect a 7% absolute risk reduction with the use of IADPSG; planned recruitment was 920 for anticipated attrition. RESULTS: From June 2015 to February 2019, 1,016 participants were enrolled and 921 were randomized to IADPSG (n=461) or Carpenter-Coustan (n=460) groups. Gestational diabetes incidence (14.4% vs 4.5%, P<.001) and diabetes medication use (9.3% vs 2.4%; P<.001) were more common in the IADPSG group; there were no differences in LGA neonates, either overall (risk reduction 0.90, 97.5% CI 0.53–1.52) or among women without gestational diabetes (risk reduction 0.85, 97.5% CI 0.49–1.48). Those screened with IADPSG had higher rates of neonatal morbidity but fewer study-related adverse events. Rates of SGA neonates, cesarean birth, and maternal morbidity composite did not differ significantly between study groups. CONCLUSIONS: The IADPSG screening criteria resulted in more women diagnosed and treated for gestational diabetes than Carpenter-Coustan without reducing the incidence of LGA birth weight or maternal or neonatal morbidity. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02309138.

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  • In Davis et al., the IADPSG group had a significantly higher incidence of GDM than the Carpenter-Coustan group (14.4% vs. 4.5%) and a higher number of women with GDM requiring medication (9.3% vs. 2.4%).

    “The IADPSG group had a significantly higher incidence of GDM than the Carpenter-Coustan group (one-step vs. two-step, 14.4% vs. 4.5%) and a higher number of women with GDM requiring medication (9.3% vs. 2.4%).”

    From Gestational Diabetes Mellitus: Diagnostic Approaches and Maternal-Offspring Complications (2022) · cites this paper as [22]

    The Results report significantly higher GDM incidence in the IADPSG group, but give 14.5% versus 4.5%, rather than the claimed 14.4% versus 4.5%. They also report that IADPSG participants were more likely to receive GDM medication, but the Results passage does not give the claimed 9.3% versus 2.4% figures. No page numbers are provided in our copy. (LLM, conf=0.85)

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  • In Davis et al., there was no significant difference in the primary outcome of large for gestational age neonates (7.7% vs. 8.5%), and no differences in other maternal or neonatal adverse pregnancy outcomes, with the exception of a higher risk of neonatal hypoglycemia in the IADPSG group.

    “However, there was no significant difference in the primary outcome of LGA neonates (7.7% vs. 8.5%), and no differences in other maternal or neonatal adverse pregnancy outcomes, with the exception of a higher risk of neonatal hypoglycemia in the IADPSG group.”

    From Gestational Diabetes Mellitus: Diagnostic Approaches and Maternal-Offspring Complications (2022) · cites this paper as [22]

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  • Taken together, the RCTs suggest a significant increase in both GDM incidence and health care utilization when using the one-step approach suggested by the IADPSG, with no commensurate improvement in adverse pregnancy outcomes compared to the two-step approach.

    “Taken together, these RCTs suggest a significant increase in both GDM incidence and health care utilization when using the one-step approach suggested by the IADPSG, with no commensurate improvement in adverse pregnancy outcomes compared to the two-step approach (Table 2).”

    From Gestational Diabetes Mellitus: Diagnostic Approaches and Maternal-Offspring Complications (2022) · cites this paper as [22]

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Authors
Davis, E. M., Abebe, K. Z., Simhan, H. N., Catalano, P., Costacou, T., Comer, D., Orris, S., Ly, K., Decker, A., Mendez, D., Day, N., & Scifres, C. M.
Affiliations
Tufts University (US)
ORCID
Venue
Obstetrics & Gynecology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2021-06-09
Volume
138
Issue
1
Pages
6-15
ISSN
0029-7844 (ISSN-L)
DOI
10.1097/aog.0000000000004431
PMC
PMC8288467
OpenAlex
W3174459054
Cited by
78
References
36
Citations by year
2026: 9 · 2025: 10 · 2024: 18 · 2023: 15 · 2022: 17 · 2021: 9
FWCI
13.35
Type
journal article
Language
en
Open access
Locations
  • Obstetrics and Gynecology (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • IUScholarWorks (Indiana University) (submittedVersion)
Funders
  • University of Pittsburgh (UL1-TR-001,857)
  • National Institutes of Health (UL1TR001857)
  • National Institute of Child Health and Human Development
  • National Center for Advancing Translational Sciences
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD079647)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
gestational diabetes mellitus, prenatal screening, IADPSG criteria, Carpenter and Coustan criteria, large-for-gestational-age neonates, small for gestational age, cesarean section, neonatal morbidity, maternal morbidity, oral glucose tolerance test, screening strategy comparison, diabetes medication use, perinatal outcomes
MeSH terms
Adult, Female, Fetal Macrosomia, Humans, Infant, Newborn, Mass Screening, Pennsylvania, Pregnancy, Pregnancy Outcome, Diabetes, Gestational, Young Adult

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