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Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes
Open accessAbstract
BACKGROUND: We conducted a randomized clinical trial to determine whether treatment of women with gestational diabetes mellitus reduced the risk of perinatal complications. METHODS: We randomly assigned women between 24 and 34 weeks' gestation who had gestational diabetes to receive dietary advice, blood glucose monitoring, and insulin therapy as needed (the intervention group) or routine care. Primary outcomes included serious perinatal complications (defined as death, shoulder dystocia, bone fracture, and nerve palsy), admission to the neonatal nursery, jaundice requiring phototherapy, induction of labor, cesarean birth, and maternal anxiety, depression, and health status. RESULTS: The rate of serious perinatal complications was significantly lower among the infants of the 490 women in the intervention group than among the infants of the 510 women in the routine-care group (1 percent vs. 4 percent; relative risk adjusted for maternal age, race or ethnic group, and parity, 0.33; 95 percent confidence interval, 0.14 to 0.75; P=0.01). However, more infants of women in the intervention group were admitted to the neonatal nursery (71 percent vs. 61 percent; adjusted relative risk, 1.13; 95 percent confidence interval, 1.03 to 1.23; P=0.01). Women in the intervention group had a higher rate of induction of labor than the women in the routine-care group (39 percent vs. 29 percent; adjusted relative risk, 1.36; 95 percent confidence interval, 1.15 to 1.62; P<0.001), although the rates of cesarean delivery were similar (31 percent and 32 percent, respectively; adjusted relative risk, 0.97; 95 percent confidence interval, 0.81 to 1.16; P=0.73). At three months post partum, data on the women's mood and quality of life, available for 573 women, revealed lower rates of depression and higher scores, consistent with improved health status, in the intervention group. CONCLUSIONS: Treatment of gestational diabetes reduces serious perinatal morbidity and may also improve the woman's health-related quality of life.
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In the citing paper
“The results of the ACHOIS trial showed that treatment did not reduce the rates of symptomatic neonatal hypoglycemia or jaundice requiring phototherapy.8”
From A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes (2009) · cites this paper as [8]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In the MFMU study, no changes were noted in the composite endpoint, but the incidence of LGA and shoulder dystocia decreased significantly [2,29,30].”
From Gestational Diabetes Mellitus—Recent Literature Review (2022) · cites this paper as [2]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In the ACHOIS study, the composite endpoint (neonatal death, perinatal injury, hyperbilirubinemia, neonatal hypoglycemia and hyperinsulinemia) was significantly reduced with antihyperglycemic intervention, and there was also a lower weight gain (by 1.7 kg on average) and a lower incidence of LGA.”
From Gestational Diabetes Mellitus—Recent Literature Review (2022) · cites this paper as [2]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The expected bene fi ts of using IADPSG criteria to the offspring are inferred from intervention trials that focused on individuals with lower levels of hyperglycemia than those identi fi ed using older GDM diagnostic criteria. Those trials found modest bene fi ts, including reduced rates of largefor-gestational-age births and preeclampsia (211,212).”
From 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024 (2024) · cites this paper as [212]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Of note, 80-90% of participants being treated for mild GDM in these two randomized controlled trials could be managed with lifestyle therapy alone.”
From 2. Diagnosis and classification of diabetes: standards of care in diabetes-2025 (2025) · cites this paper as [195]
Experimental — accuracy not yet measured
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Although the diagnostic criteria for GDM differ, several randomized controlled trials (RCTs) have provided evidence of improved perinatal outcomes of GDM in the second half of pregnancy.”
From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [13]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“For some women, the diagnosis is a catalyst for positive behavioural change 36 and improved quality of life. 15”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [15]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“This approach is based on available trial evidence, 15 , 16”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [15]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“Overall, consistent with findings from the ACHOIS trial, the findings from our trial confirm a modest benefit from the identification and treatment of women with mild carbohydrate intolerance during pregnancy.8”
From A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes (2009) · cites this paper as [8]
The cited source says what the claim attributes to it.
In the citing paper
“The Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS), a large, randomized trial of treatment for gestational diabetes mellitus, concluded that treatment reduces serious perinatal complications and may also improve health-related quality of life.8”
From A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes (2009) · cites this paper as [8]
The cited source says what the claim attributes to it.
In the citing paper
“Consistent with the results of our trial, the ACHOIS trial also showed a reduction in the rate of shoulder dystocia when women with mild gestational diabetes mellitus received treatment (1%, vs. 3% in the untreated group).8”
From A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes (2009) · cites this paper as [8]
The cited source says what the claim attributes to it.
In the citing paper
“Two randomized clinical trials (RCTs) in women with GDM demonstrated the improvement of these pregnancy outcomes in women identified with and treated for GDM compared with women left untreated [6,7].”
From Gestational Diabetes Mellitus: Diagnostic Approaches and Maternal-Offspring Complications (2022) · cites this paper as [7]
The cited source says what the claim attributes to it.
In the citing paper
“There are two randomized trials showing that treatment of mild GDM (predominantly with diet) compared with standard pregnancy care was associated with improved pregnancy outcomes (22,23)”
From Metformin in Gestational Diabetes: The Offspring Follow-Up (MiG TOFU) (2011) · cites this paper as [22]
The cited source says what the claim attributes to it.
In the citing paper
“Both studies found that treatment of GDM can reduce both serious adverse outcomes and the frequency of large babies (macrosomia) (174,175).”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [174]
The cited source says what the claim attributes to it.
In the citing paper
“Two randomized clinical trials have now demonstrated a benefit from the treatment of”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [174]
The cited source says what the claim attributes to it.
In the citing paper
“The treatment of even mild forms of glucose intolerance in GDM offers an added benefit, as demonstrated by the Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) and Maternal-Fetal Medicine Units Network (MFMU).”
From Gestational Diabetes Mellitus—Recent Literature Review (2022) · cites this paper as [2]
The cited source says what the claim attributes to it.
In the citing paper
“Although two RCTs found that treatment of GDM can reduce perinatal morbidity (264,265), it is not known whether treatment reduces long-term risks in children.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [264]
The cited source says what the claim attributes to it.
In the citing paper
“It is important to note that 80 -90% of participants being treated for mild GDM in these two randomized controlled trials could be managed with lifestyle therapy alone.”
From 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024 (2024) · cites this paper as [212]
The cited source says what the claim attributes to it.
In the citing paper
“The OGTT glucose cutoffs in these two trials overlapped the thresholds recommended by the IADPSG, and in one trial (212), the 2-h PG threshold (140 mg/dL [7.8 mmol/L]) was lower than the cutoff recommended by the IADPSG (153 mg/dL [8.5 mmol/L]).”
From 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024 (2024) · cites this paper as [212]
The cited source says what the claim attributes to it.
In the citing paper
“The OGTT glucose cutoffs in these two trials overlapped the thresholds recommended by the IADPSG, and in one trial (195), the 2-h PG threshold (140 mg/dL [7.8 mmol/L]) was lower than the cutoff recommended by the IADPSG (153 mg/dL [8.5 mmol/L]).”
From 2. Diagnosis and classification of diabetes: standards of care in diabetes-2025 (2025) · cites this paper as [195]
The cited source says what the claim attributes to it.
In the citing paper
“Those trials found modest benefits, including reduced rates of largefor-gestational-age births and preeclampsia (194,195).”
From 2. Diagnosis and classification of diabetes: standards of care in diabetes-2025 (2025) · cites this paper as [195]
The cited source says what the claim attributes to it.
In the citing paper
“However, that RCT study was not based on the IADPSG criteria for GDM.”
From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [13]
The cited source says what the claim attributes to it.
In the citing paper
“In the GDM cases in ACHOIS, the intervention group had a significantly lower risk of neonatal complications than the non‐intervention group 13 .”
From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [13]
The cited source says what the claim attributes to it.
In the citing paper
“women should be counselled that identification and treatment of gestational diabetes mellitus defined by elevated glucose concentrations following a glucose load is supported by high quality evidence, 15 , 16”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [15]
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“Follow-up of the children in both these studies at 4 to 5 (264-266) and 7 years of age (267), respectively, failed to observe differences in limited indicators of child adiposity between children of mothers with treated GDM and those with untreated GDM.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [264]
Experimental — accuracy not yet measuredIn the citing paper
“Blood glucose-lowering pharmacological therapy is effective at improving outcomes in women with gestational diabetes whose hyperglycemia does not respond sufficiently to lifestyle therapy (71, 82, 88–90).”
From Diabetes and Pregnancy: An Endocrine Society Clinical Practice Guideline (2013) · cites this paper as [82]
In the citing paper
“Despite recent improvements in maternal glycemic control and a reduction in the frequency of perinatal complications, the prevalence of adverse pregnancy outcomes continues to be higher than the general population.12,23”
From Gestational Diabetes Mellitus (2019) · cites this paper as [12]
In the citing paper
“Although the diagnostic tests and criteria used in the 2 RCTs differed substantially, treatment outcomes were quite similar (Table 1)”
From Gestational Diabetes Mellitus (2019) · cites this paper as [12]
In the citing paper
“Medical nutrition therapy (MNT) is a cornerstone of therapy for all women with GDM, and approximately 80% to 90% of women are able to meet therapeutic targets with MNT alone.12,13”
From Gestational Diabetes Mellitus (2019) · cites this paper as [12]
In the citing paper
“Multiple benefits have been attributed to lifestyle interventions, including decreased risk of macrosomia, decreased neonatal adiposity, and increased likelihood to achieve postpartum weight goals.12,13,50”
From Gestational Diabetes Mellitus (2019) · cites this paper as [12]
In the citing paper
“which fits with other data showing that maternal glycemia relates to birth weight.21–23”
From Metformin in gestational diabetes: the offspring follow-up (MiG TOFU): body composition and metabolic outcomes at 7-9 years of age (2018) · cites this paper as [21]
In the citing paper
“For example, in ACHOIS, 28 the rate of LGA was reduced from 21.95% to 13.44%, a 38.8% reduction, in the women who were identified and treated compared with the women whose GDM was not identified.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [28]
In the citing paper
“The incidence estimates, as stated in the online appendix (Supplemental Table 2 1 ), were based on reported outcomes in the Australian Carbohydrate Intolerance Study (ACHOIS) study, 28 an RCT that comprised high-risk women diagnosed as having mild GDM”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [28]
In the citing paper
“A similar analysis applies to the 35% reduction in preeclampsia, reported with diagnosis and treatment in ACHOIS, 28 to the additional 12% undiagnosed cases of mild GDM in group 2. The reported rate of preeclampsia or gestational hypertension in the treated GDM women in group 2 was 20.3%.Based on these values and calculations similar to those above for LGA, we obtain a relative risk estimate of 1.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [28]
In the citing paper
“Of importance, the incidence figures for adverse outcomes in ACHOIS 28 included only pregnancies with GDM.It is not clear how these ACHOIS figures factored into the sample size estimates, because the current study looked at the outcomes in the overall screened groups, rather than only in those with GDM.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [28]
In the citing paper
“ACHOIS compared 1 group (N¼506) identified and treated for their mild GDM and the other group (N¼524) blinded, along with their caregivers, to the diagnosis.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [28]
In the citing paper
“For example, the perinatal composite outcomes occurred in 4% of the untreated GDMs in ACHOIS yet the current study estimated its incidence as 4% in the entire sample.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [28]
In the citing paper
“Participants in the ACHOIS study 28 had 75 g, 2-hour OGTT plasma glucose between 140 mg/dL and 198 mg/dL, indicating milder GDM than those diagnosed by IADPSG criteria.17”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [28]
In the citing paper
“As shown in Table 3, the relative risk for some of the main adverse immediate outcomes were significantly reduced, by similar proportions of 40% to 60% for LGA and macrosomic babies and 30% to 40% for hypertensive disorders of pregnancy, when mild GDM was recognized and treated.”
From One-step or 2-step testing for gestational diabetes: which is better? (2021) · cites this paper as [28]
In the citing paper
“the two trials that focused on the treatment of”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [174]
In the citing paper
“Both studies found that treatment of GDM can reduce both serious adverse outcomes and the frequency of large babies (macrosomia) (174,175).”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [174]
In the citing paper
“Considering this, the prevalence of the various maternal adverse events is similar to the 'routine care' groups in the Crowther et al. [10] and Landon et al. [11] studies.”
From Atlantic Diabetes in Pregnancy (DIP): the prevalence and outcomes of gestational diabetes mellitus using new diagnostic criteria (2011) · cites this paper as [10]
In the citing paper
“Unlike our study, Metzger et al. [2], Crowther et al. [10] and Landon et al. [11] excluded women with greater degrees of hyperglycaemia.”
From Atlantic Diabetes in Pregnancy (DIP): the prevalence and outcomes of gestational diabetes mellitus using new diagnostic criteria (2011) · cites this paper as [10]
In the citing paper
“It is important to note that 80–90% of women in both of the mild GDM studies (whose glucose values overlapped with the thresholds recommended herein) could be managed with lifestyle therapy alone.”
From Diagnosis and classification of diabetes mellitus (2013) · cites this paper as [16]
In the citing paper
“Expected benefits to their pregnancies and offspring is inferred from intervention trials that focused on women with more mild hyperglycemia than identified using older GDM diagnostic criteria and that found modest benefits (15,16).”
From Diagnosis and classification of diabetes mellitus (2013) · cites this paper as [16]
In the citing paper
“Two randomized controlled trials comparing active treatment versus standard obstetric care for mild GDM have been conducted during the years in which the HAPO study was carried out (47,48).”
From International Association of Diabetes and Pregnancy Study Groups Recommendations on the Diagnosis and Classification of Hyperglycemia in Pregnancy (2010) · cites this paper as [47]
In the citing paper
“Although not directly comparable, it was concluded that results of the two randomized controlled trials (47,48) and HAPO (25,26) are highly complementary.”
From International Association of Diabetes and Pregnancy Study Groups Recommendations on the Diagnosis and Classification of Hyperglycemia in Pregnancy (2010) · cites this paper as [47]
In the citing paper
“In both randomized controlled trials, treatment, achieved primarily by diet/lifestyle modification, resulted in reduced birth weight and frequency of LGA births and preeclampsia.”
From International Association of Diabetes and Pregnancy Study Groups Recommendations on the Diagnosis and Classification of Hyperglycemia in Pregnancy (2010) · cites this paper as [47]
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Metadata
- Authors
- Crowther, C. A., Hiller, J. E., Moss, J. R., McPhee, A. J., Jeffries, W. S., & Robinson, J. S.
- Affiliations
- The University of Adelaide (AU)
- Women's and Children's Hospital (AU)
- Lyell McEwin Hospital (AU)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2005-06-16
- Volume
- 352
- Issue
- 24
- Pages
- 2477-2486
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2074307717
- Cited by
- 3,159
- References
- 30
- Citations by year
- 2026: 116 · 2025: 105 · 2024: 117 · 2023: 147 · 2022: 159 · 2021: 193 · 2020: 189 · 2019: 163 · 2018: 195 · 2017: 163 · 2016: 163 · 2015: 168 · 2014: 187 · 2013: 172 · 2012: 169
- FWCI
- 111.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research Bank (Australian Catholic University) (submittedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- 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, perinatal complications, insulin therapy, dietary recommendations, blood glucose monitoring, labor induction, cesarean section, neonatal jaundice, maternal depression, health-related quality of life, shoulder dystocia
- MeSH terms
- Adult, Birth Weight, Blood Glucose, Cesarean Section, Dystocia, Female, Fetal Macrosomia, Glucose Tolerance Test, Humans, Hypoglycemic Agents, Infant Mortality, Infant, Newborn, Insulin, Labor, Induced, Paralysis, Pregnancy, Pregnancy Outcome, Diabetes, Gestational, Depression, Postpartum, Fractures, Bone
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