A pragmatic, randomized clinical trial of gestational diabetes screening
Open accessAbstract
BACKGROUND: Gestational diabetes mellitus is common and is associated with an increased risk of adverse maternal and perinatal outcomes. Although experts recommend universal screening for gestational diabetes, consensus is lacking about which of two recommended screening approaches should be used. METHODS: We performed a pragmatic, randomized trial comparing one-step screening (i.e., a glucose-tolerance test in which the blood glucose level was obtained after the oral administration of a 75-g glucose load in the fasting state) with two-step screening (a glucose challenge test in which the blood glucose level was obtained after the oral administration of a 50-g glucose load in the nonfasting state, followed, if positive, by an oral glucose-tolerance test with a 100-g glucose load in the fasting state) in all pregnant women who received care in two health systems. Guidelines for the treatment of gestational diabetes were consistent with the two screening approaches. The primary outcomes were a diagnosis of gestational diabetes, large-for-gestational-age infants, a perinatal composite outcome (stillbirth, neonatal death, shoulder dystocia, bone fracture, or any arm or hand nerve palsy related to birth injury), gestational hypertension or preeclampsia, and primary cesarean section. RESULTS: A total of 23,792 women underwent randomization; women with more than one pregnancy during the trial could have been assigned to more than one type of screening. A total of 66% of the women in the one-step group and 92% of those in the two-step group adhered to the assigned screening. Gestational diabetes was diagnosed in 16.5% of the women assigned to the one-step approach and in 8.5% of those assigned to the two-step approach (unadjusted relative risk, 1.94; 97.5% confidence interval [CI], 1.79 to 2.11). In intention-to-treat analyses, the respective incidences of the other primary outcomes were as follows: large-for-gestational-age infants, 8.9% and 9.2% (relative risk, 0.95; 97.5% CI, 0.87 to 1.05); perinatal composite outcome, 3.1% and 3.0% (relative risk, 1.04; 97.5% CI, 0.88 to 1.23); gestational hypertension or preeclampsia, 13.6% and 13.5% (relative risk, 1.00; 97.5% CI, 0.93 to 1.08); and primary cesarean section, 24.0% and 24.6% (relative risk, 0.98; 97.5% CI, 0.93 to 1.02). The results were materially unchanged in intention-to-treat analyses with inverse probability weighting to account for differential adherence to the screening approaches. CONCLUSIONS: Despite more diagnoses of gestational diabetes with the one-step approach than with the two-step approach, there were no significant between-group differences in the risks of the primary outcomes relating to perinatal and maternal complications. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ScreenR2GDM ClinicalTrials.gov number, NCT02266758.).
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The HAPO study showed that increasing glycemia is associated with more neonatal adverse outcomes such as macrosomia, neonatal hypoglycemia, and cesarean delivery.
“The HAPO study showed that increasing glycemia is associated with increased neonatal adverse outcomes such as macrosomia, neonatal hypoglycemia, and cesarean delivery.64,115–119”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [64]
The Introduction links gestational diabetes with fetal overgrowth and cesarean delivery, and Methods > Study Outcomes cites the HAPO study as prior research for large-for-gestational-age infants and primary cesarean section (pages unavailable). Our copy does not state that HAPO found a graded association with increasing glycemia or link HAPO to neonatal hypoglycemia. (LLM, conf=0.75)
Experimental — accuracy not yet measuredEven among women without GDM as currently defined, maternal glucose concentration during pregnancy has a linear association with newborn weight, large-for-gestational-age rates, and cesarean delivery.
“The HAPO study confirmed findings in Pima Indians1409 that, even among offspring of women without GDM as it is currently defined, there is a linear association between maternal glucose concentration during pregnancy and newborn weight, rates of large-for-gestational-age, and cesarean delivery.64,1418–1421”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [64]
The Introduction (page not provided) states that maternal hyperglycemia has a clear linear relationship with maternal and perinatal outcomes, citing the HAPO study. It does not specify that this relationship holds among women without GDM, establish it separately for newborn weight, large-for-gestational-age rates and cesarean delivery, or describe confirmation of findings in Pima Indians. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn Hillier et al., a similar proportion of women diagnosed with GDM using the two approaches required medication to manage glucose levels during pregnancy (42.6% for one-step and 45.5% for two-step), meaning that more women who underwent the one-step approach received treatment to manage glucose during pregnancy.
“A similar proportion that were diagnosed with GDM using the two approaches required medication to manage glucose levels during pregnancy (42.6% [n=783] for one-step and 45.5% [n=431] for two-step), meaning that more women who underwent the one-step approach received treatment to manage glucose during pregnancy.”
From Gestational Diabetes Mellitus: Diagnostic Approaches and Maternal-Offspring Complications (2022) · cites this paper as [21]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredTaken 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 [21]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn that cohort study, approximately 25% of those assigned to the 1-step group went through the 2-step process and the caregivers were not blinded to assignment of the participants.
“Unfortunately, approximately 25% of those assigned to the 1-step group went through the 2-step process and the caregivers were not blinded to assignment of the participants.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [261]
Methods (Randomization; page unavailable) states that providers could not be blinded, and Methods (Statistical Methods; page unavailable) says some participants assigned to 1-step screening received 2-step screening. Results (Trial Population; page unavailable) reports 66% adherence in the 1-step arm, but does not establish that approximately 25% specifically underwent 2-step screening. The paper describes a randomized trial, not a cohort study. (LLM, conf=0.86)
Experimental — accuracy not yet measured
In a large (23,792 women) cohort study, the frequency of GDM detected with the 1-step process was approximately twice that found with the 2-step process, but no significant differences in prespecified single or composite outcomes were found between the two groups.
“The frequency of GDM detected with the 1-step process was approximately twice that found with the 2-step process, but no significant differences in prespecified single or composite outcomes were found between the two groups.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [261]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredHillier et al. showed that one-step screening, compared with two-step screening, doubled the incidence of GDM diagnosis but did not affect risks of LGA, adverse perinatal outcomes, primary Caesarean section, gestational hypertension or pre-eclampsia.
“In a large randomized trial (among 23,792 pregnant women), Hillier et al. showed that one-step screening, as compared with two-step screening, doubled the incidence of the diagnosis of GDM, but did not affect the risks of LGA, adverse perinatal outcomes, primary Caesarean section, or gestational hypertension or pre-eclampsia [32].”
From Gestational Diabetes Mellitus—Recent Literature Review (2022) · cites this paper as [32]
In that cohort study, different glucose cutoffs for the 2-step screening were applied at the two sites.
“Moreover, different glucose cutoffs for the 2-step screening were applied at the two sites.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [261]
Data that compare population-wide outcomes with one-step versus two-step approaches have been inconsistent to date.
“Data that compare population-wide outcomes with one-step versus two-step approaches have been inconsistent to date (213,230 -232).”
From 2. Diagnosis and Classification of Diabetes: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [213]
A recent randomized trial of testing for GDM at 24-28 weeks by the one-step IADPSG method versus the two-step method identified twice as many individuals with GDM using the one-step method; despite treating more individuals, there was no difference in pregnancy and perinatal complications.
“However, a recent randomized trial of testing for GDM at 24 -28 weeks of gestation by the one-step method using IADPSG criteria versus the two-step method using a 1-h 50-g glucose loading test (GLT) and, if positive, a 3-h OGTT by Carpenter-Coustan criteria identi fi ed twice as many individuals with GDM using the one-step method compared with the two-step method. Despite treating more individuals”
From 2. Diagnosis and Classification of Diabetes: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [213]
Data that compare population-wide outcomes with one-step versus two-step approaches have been inconsistent to date.
“Data that compare population-wide outcomes with one-step versus two-step approaches have been inconsistent to date (196,(212)(213)(214).”
From 2. Diagnosis and classification of diabetes: standards of care in diabetes-2025 (2025) · cites this paper as [196]
Using the one-step strategy, gestational diabetes mellitus was diagnosed in double the number of women compared with the two-step method.
“The results showed that using the one-step strategy, GDM was diagnosed in doubled number of women in comparison with the two-step method.”
From Evolution of Gestational Diabetes Mellitus across Continents in 21st Century (2022) · cites this paper as [44]
There was no disparity between maternal and perinatal outcomes between the one-step and two-step screening strategies.
“Nevertheless, there was no disparity between maternal and perinatal outcomes, while more pregnant women were treated for GDM after diagnosis with the one-step method [44].”
From Evolution of Gestational Diabetes Mellitus across Continents in 21st Century (2022) · cites this paper as [44]
More pregnant women were treated for gestational diabetes mellitus after diagnosis with the one-step method.
“while more pregnant women were treated for GDM after diagnosis with the one-step method [44].”
From Evolution of Gestational Diabetes Mellitus across Continents in 21st Century (2022) · cites this paper as [44]
The trial's prespecified primary outcomes and estimated incidences were gestational diabetes requiring insulin or oral agents 20%, gestational hypertension 15%, macrosomia 12%, cesarean delivery 25%, and a perinatal composite outcome 4%.
“The prespecified primary outcomes (estimated incidences) were GDM requiring insulin or oral agents (20%), gestational hypertension (blood pressure of >140/90 twice after 20 weeks, no previous hypertension diagnosis, 15%), macrosomia (birthweight at the >90th percentile, 12%), cesarean delivery (25%), and a perinatal composite outcome consisting of stillbirth, neonatal death, shoulder dystocia, b”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The trial assumed gestational diabetes would be diagnosed in 18% of women randomized to 1-step testing and 6% of women randomized to 2-step screening, a 12% difference.
“The study design assumed that GDM would be diagnosed in 18% of women randomized to 1-step testing (group 1) and 6% of women randomized to 2-step screening (group 2), a 12% difference.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
In the Hillier et al trial, gestational diabetes was more common in the 1-step group (16.5% vs 8.5%), but there were no significant differences in large-for-gestational-age infants, gestational hypertension or preeclampsia, primary cesarean delivery, or the primary composite outcome.
“Although GDM was more common in the women randomized to receive 1-step testing (16.5% vs 8.5%), there were no significant differences between the 2 groups with respect to large for gestational age (LGA) infants (8.9% vs 9.2%), gestational hypertension or preeclampsia (13.6% vs 13.5%), primary cesarean delivery (24% vs 24.6%), or the primary composite outcome (3.1% vs 3.0%).”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The Hillier et al randomized trial found no significant differences in adverse outcomes between women diagnosed by 1-step versus 2-step testing, even though about twice as many women in the 1-step group were diagnosed with gestational diabetes and treated.
“The authors reported no signifi-cant between-group differences in adverse outcomes between women diagnosed using either approach, despite the fact that the number of women diagnosed as having GDM, and treated accordingly, were approximately doubled in women randomized to the 1step approach.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The trial investigators did not describe the estimates of treatment effect that underpinned the estimated relative risk of 1.2 for most adverse outcomes.
“The investigators do not describe estimates of the effect of treatment of GDM underpinning the estimated relative risk of 1.2 for most of the adverse outcomes.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The Hillier et al randomized controlled trial did not provide a definitive answer about which gestational diabetes testing protocol is more advantageous for patients and the healthcare system.
“we shall endeavor to outline why we believe that Hillier et al's 1 randomized controlled trial (RCT) fell short of delivering a definitive answer to which of the 2 protocols is most advantageous to our patients and to the healthcare system.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The Hillier et al randomized trial was intended to test whether 1-step or 2-step gestational diabetes screening and treatment improves outcomes in an entire obstetrical population under standard clinical care.
“The recent RCT by Hillier et al 1 was intended to investigate whether the 1step or 2-step approach to GDM screening and treatment results in improved outcomes in an entire obstetrical population in the setting of standard clinical care, including the excellent Kaiser Permanente system's protocol-based approach to care.27”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
In calculating sample size, the trial authors decided that a relative risk of 1.2, meaning a 20% higher rate in the 2-step group, would be meaningful evidence of benefit for the 1-step protocol.
“In calculating the needed sample size, the authors decided that a relative risk of 1.2, meaning a 20% higher rate for each adverse outcome in group 2 than in group 1, would be meaningful evidence of a benefit of the 1-step protocol.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
In group 1, 3247 of 11,922 women (27%) were screened by the 2-step protocol instead of the intended 1-step protocol, and 795 (6.7%) had neither type of screening.
“In group 1, of 11,922 women, 3247 (27%) were screened by the 2-step protocol instead of the intended 1-step protocol, and 795 (6.7%) had neither type of screening (778 had none at all; 17 had only a first trimester A1c).”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
Suboptimal adherence to assigned testing protocols, especially the 27% crossover in group 1 to the 2-step protocol and nontesting of many women in each group, throws into question the intention-to-treat analyses.
“In addition, the high level of suboptimal adherence to the assigned testing protocols, particularly the crossover in group 1 to the 2-step protocol of 27% of randomized women and the nontesting of so many women in each group, further throws into question the intention-to-treat analyses.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
A total of 92 gestational diabetes cases were diagnosed after oral glucose tolerance tests based on screening tests of 130 to 139 mg/dL, comprising 9.7% of the 945 gestational diabetes cases diagnosed in group 2.
“A total of 92 GDMs were diagnosed after OGTTs based on screening tests of 130 to 139 mg/dL, comprising 9.7% of the 945 GDMs diagnosed in group 2.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The 50 g 1-hour screening cutoff in group 2 was 130 mg/dL or higher at Kaiser Northwest (N=8140) but 140 mg/dL or higher in Hawaii (N=3730).
“Another inconsistency within the protocol was that the cutoff for the 50 g, 1-hour screen in group 2 was !130 mg/ dL for women recruited at the Kaiser Northwest site (N¼8140), but !140 mg/ dL in those recruited in Hawaii (N¼3730).”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
In the two compared groups, the use of insulin or oral antidiabetic drugs was similar, at 43% and 46%, under the same protocol-based care.
“The fact that the institution of medical treatment with insulin or oral antidiabetic agents was similar between the 2 groups (43% and 46%), using the same protocol-based approach to care”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
In group 2, 281 of 11,870 women (2.4%) had 1-step screening instead of the assigned 2-step protocol, and 708 (6%) had neither type of screening.
“In group 2, of 11,870 women, 281 (2.4%) had 1-step screening instead of the assigned 2-step protocol, and 708 (6%) had neither type of screening (672 had none at all; 36 had only a first trimester A1c).”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The subset of 165 group 2 women who did not have GDM by the 2-step protocol but were treated as GDM because of elevated fasting glucose levels presumably lowered adverse outcomes in group 2 and blurred the comparison with group 1.
“The subset of 165 group 2 women who did not have GDM by the 2-step protocol and were not counted among the GDMs, but were treated as such because of elevated fasting glucose levels, presumably lowered the number of adverse outcomes in group 2 and helped blur the comparison with adverse outcomes in group 1.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The trial design included identifying and treating women in group 2 who did not have two or more elevated values on the 100 g 3-hour oral glucose tolerance test but whose fasting plasma glucose was 95 mg/dL or above.
“The study design included identifying and treating women in group 2 who did not have 2 or more elevated values on the 100 g, 3-hour OGTT but whose fasting plasma glucose was 95 mg/dL or above (Supplemental Appendix, Section 2.5 1 ).”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The study ignored demonstrated opportunities to improve long-term morbidity such as future type 2 diabetes in women with GDM and potential opportunities to reduce long-term morbidity in offspring.
“Demonstrated opportunities for improvement in long-term morbidity such as future type 2 diabetes mellitus in the woman with GDM were ignored in the study, as were potential opportunities for”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
The GDM rate in the obstetrical population using the 1-step approach, even as projected by the authors to be 19.9% in the Hillier et al RCT, is lower than the prediabetes rate in reproductive-aged women.
“The rate of GDM in the obstetrical population using the 1-step approach, even as projected by us to be 19.9% in the RCT by Hillier et al 1 is lower than the prediabetes rate in reproductive aged women.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [1]
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Hillier, T. A., Pedula, K. L., Ogasawara, K. K., Vesco, K. K., Oshiro, C. E. S., Lubarsky, S. L., & Marter, J. L. V. (2021) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2021.08.006 · Cited by 7 · see citing works
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Gestational diabetes: screening, diagnosis, treatment and management
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- Authors
- Hillier, T. A., Pedula, K. L., Ogasawara, K. K., Vesco, K. K., Oshiro, C. E. S., Lubarsky, S. L., & Van Marter, J.
- Affiliations
- Kaiser Permanente (US)
- From the Center for Health Research, Kaiser Permanente Northwest (T.A.H., K.L.P., K.K.V., J.V.M.), and the Division of Perinatology, Department of Obstetrics and Gynecology, Northwest Permanente, Kaiser Permanente (S.L.L.), Portland, Oregon; and the Center for Integrated Health Care Research (T.A.H., C.E.S.O.) and the Division of Perinatology, Department of Obstetrics and Gynecology (K.K.O.), Hawaii Permanente Medical Group (K.L.P., K.K.O.), Kaiser Permanente Hawaii, Honolulu.
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-03-11
- Volume
- 384
- Issue
- 10
- Pages
- 895-904
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC9041326
- OpenAlex
- W3135372304
- Cited by
- 270
- References
- 33
- Citations by year
- 2026: 27 · 2025: 36 · 2024: 48 · 2023: 53 · 2022: 65 · 2021: 40
- FWCI
- 46.72
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD074794)
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- gestational diabetes mellitus, gestational diabetes screening, two-stage screening, glucose challenge test, oral glucose tolerance test, large for gestational age, perinatal outcomes, gestational hypertension, preeclampsia, cesarean section, screening adherence, maternal outcomes, birth trauma, shoulder dystocia, nerve palsy
- MeSH terms
- Adult, Blood Glucose, Female, Fetal Macrosomia, Glucose Tolerance Test, Humans, Hyperglycemia, Mass Screening, Pregnancy, Pregnancy Outcome, Incidence, Diabetes, Gestational
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