Determinants of progression of diabetic retinopathy in pregnancy.

AIMS: To assess the rate of diabetic retinopathy (DR) progression in an Australian cohort and to identify the determinants of DR progression in pregnancy. METHODS: A total of 367 pregnancies of women with Type 1 or 2 diabetes mellitus attending King Edward Memorial Hospital, Western Australia, between June 2020 and July 2023 were included. These women were screened for the presence and severity of DR in the first trimester and/or at 28-32 weeks gestation via retinal imaging with a DRS camera. RESULTS: DR was seen in 121 (33 %) pregnancies at baseline and DR progression was seen in 62 (17 %) pregnancies. Only 11 (4 %) women with no baseline DR developed DR and none of these progressed to more than moderate non-proliferative DR. A total of 51 (42 %) women with baseline DR had DR progression. The presence of baseline DR was the only significant predictor for DR progression on multivariate analysis (OR 9.88 (4.43-22.07), p < 0.001). CONCLUSIONS: Women without DR at baseline are unlikely to progress to more severe forms of DR and usually do not require treatment. The presence of DR at baseline screening during pregnancy is a strong predictor of DR progression during pregnancy.

Perinatal Outcomes Associated With Metformin Use During Pregnancy in Women With Pregestational Type 2 Diabetes Mellitus.

OBJECTIVE: We emulated a modified randomized trial (Metformin in Women With Type 2 Diabetes in Pregnancy [MiTy]) to compare the perinatal outcomes in women continuing versus discontinuing metformin during pregnancy among those with type 2 diabetes treated with metformin plus insulin before pregnancy. RESEARCH DESIGN AND METHODS: This study used two health care claims databases (U.S., 2000-2020). Pregnant women age 18-45 years with type 2 diabetes who were treated with metformin plus insulin at conception were eligible. The primary outcome was a composite of preterm birth, birth injury, neonatal respiratory distress, neonatal hypoglycemia, and neonatal intensive care unit admission. Secondary outcomes included the components of the primary composite outcome, gestational hypertension, preeclampsia, maternal hypoglycemia, cesarean delivery, infants large for gestational age, infants small for gestational age (SGA), sepsis, and hyperbilirubinemia. We adjusted for potential baseline confounders, including demographic characteristics, comorbidities, and proxies for diabetes progression. RESULTS: Of 2,983 eligible patients, 72% discontinued use of metformin during pregnancy. The average age at conception was 32 years, and the prevalence of several comorbidities was higher among continuers. The risk of the composite outcome was 46% for continuers and 48% for discontinuers. The adjusted risk ratio was 0.92 (95% CI 0.81, 1.03). Risks were similar between treatments and consistent between databases for most secondary outcomes, except for SGA, which was elevated in continuers only in the commercially insured population. CONCLUSIONS: Our findings were consistent with those reported in the MiTy randomized trial. Continuing metformin during pregnancy was not associated with increased risk of a neonatal composite adverse outcome. However, a possible metformin-associated risk of SGA warrants further consideration.

Factors Affecting Mode of Birth in Women With Preexisting Diabetes and Gestational Diabetes: A Retrospective Cohort at a Tertiary Referral Center.

Women with preexisting diabetes and gestational diabetes mellitus (GDM) are at higher risk for adverse maternal and neonatal outcomes. However, there is no consensus on a uniform approach regarding mode of birth (MOB) for all forms of diabetes. The aim of the study is to compare MOB in women with preexisting diabetes and GDM and possible factors influencing it. A retrospective cohort study of women with GDM and preexisting diabetes between 2015 and 2021 at a tertiary referral center was conducted. One thousand three hundred eighty-five singleton pregnancies were included. One thousand twenty-two (74.4%) women had a vaginal birth (VB) and 351 (25.6%) a caesarean section. Preexisting diabetes was significantly associated with caesarean section compared to GDM (OR 2.43). Five hundred fifty-one (40.1%) women underwent induction of labor, and 122 (22.1%) women had a secondary caesarean after IOL. Women induced due to spontaneous rupture of membrane (SROM) achieved the highest rate of VB at 93%. The lowest rates of VB occurred if indication for induction was for preeclampsia or hypertension. IOL was significantly less successful in preexisting diabetes with a VB achieved in 56.4% for type 1 diabetes and 52.6% of type 2 diabetes compared to GDM (78.2% in GDM; 81.2% in IGDM; OR 3.25, 95% CI 1.70-6.19, p < 0.001). The rate of VB was higher who were induced preterm compared to women with term IOL (n = 240 (81.9%) vs. n = 199 (73.2%); p < 0.05). Parity, previous VB and SROM favored VB after IOL, whereas preexisting diabetes, hypertension, and IOL after 40 + 0 weeks are independent risk factors for caesarean delivery.

Real-world data on the Minimed 780G advanced hybrid closed-loop system use during type 1 diabetes pregnancy: One centre observational study.

Aim The efficacy of hybrid closed-loop systems (HCLs) in managing glycemic control in pregnant women with type 1 diabetes remains inadequately characterized. We evaluated the use of the Medtronic Minimed 780G HCLs. METHODS: The retrospective observational study analyzed the glycemic and perinatal outcomes of pregnant women using the HCLs, followed at our tertiary centre. Independent t-tests were employed to compare data among trimesters based on pre-pregnancy HbA1c. The associations between glycemic parameters and perinatal outcomes were explored using Spearman rho. RESULTS: Among the 21 women (age: 33.5 ± 4.2 years, diabetes duration: 21.2 ± 7.6 years, pre-pregnancy HbA1c 7.0 ± 1.1 % (52.9 ± 11.9 mmol/mol)) time in range (pTIR, 63-140 mg/dl; 3.5-7.8 mmol/l) increased progressively throughout pregnancy (trimesters: first: 64.0 ± 9.0 %; second:71.3 ± 11.8 %; third: 75.7 ± 8.1 %). Simultaneously, mean sensor glucose decreased (trimesters: first: 130 ± 10.4 mg/dl (7.2 ± 0.6 mmol/l); second: 120.9 ± 13.4 mg/dl (6.7 ± 0.7 mmol/l); third: 117.3 ± 9.1 mg/dl (6.5 ± 0.5 mmol/l)). Although a majority of women achieved the target pTIR until the third trimester, this did not consistently prevent the delivery of a large-for-gestational-age baby. Notably, one ketoacidosis event occurred, and there were no reported instances of severe hypoglycemia. CONCLUSION: Use of the Minimed 780G HCLs enabled the attainment of recommended pregnancy glycemic targets for most women with type 1 diabetes in a real-world setting.

Maternal poor glycemic control increases risk of neonatal left ventricular hypertrophy.

BACKGROUND: Left ventricular hypertrophy (LVH) is an important complication of infants of diabetic mothers (IDMs). However, the defined factors, such as the influence of glycemic control, insulin administration of diabetic mothers and large for gestational age (LGA) in infants, are largely unknown on the incidence of LVH. Therefore, this study aimed to evaluate the prevalence of maternal and neonatal risk factors associated with LVH in IDMs. METHODS: This prospective analytic study was conducted at tertiary care hospitals in a 1-year period. Inborn IDMs were enrolled, and ventricular hypertrophy was identified by 2D echocardiography in the first 72 hours after birth. RESULTS: A total of 160 IDMs met the inclusion criteria, 33 (20.6%) of which had LVH. The incidence of infants with LVH born to mothers with poor glycemic control (fasting blood sugar >95 mg/dL) was significantly elevated than those with good glycemic control (45.5% vs. 14.4%, P<0.001). Twelve IDMs (12/33, 36.5%) of LVH and 17 IDMs (17/127, 13.4%) of non-LVH were LGA. IDMs with LVH, compared those with non-LVH, had significantly increased left ventricular (LV) geometry; IVSd (6.5±0.8 vs. 4.0±0, 7 mm), LV IDd (16.8±3.3 mm vs. 18.4±1.1), left ventricular ejection fraction (LVEF) (68.3±8.5% vs. 62.9±17.5%), left ventricular fraction shortening (LVFS) (35.9±6.6% vs. 32.2±5.5%), LV mass (15.3±11.6 vs. 9.3±2.5 g) and LV mass index (66.2±17.5 vs. 46.6±9.7 g/m2), all with P<0.001. There was significant correlation in LV mass with infants' weight, height and body surface area (BSA) (r=0.408, 0.337 and 0.424, respectively; P<0.001). CONCLUSIONS: The prevalence of neonatal ventricular hypertrophy in IDMs was 20.6%. Maternal poor glycemic control and LGA status in IDMs were dominant risk factors of LVH.

Pregnancy Outcomes in Women with Poorly Controlled Pregestational Diabetes Mellitus.

BACKGROUND: The prevalence of pregestational diabetes mellitus (PGDM) in women of reproductive age has surged globally, contributing to increased rates of adverse pregnancy outcomes. Hemoglobin A1c (HbA1c) is a crucial marker for diagnosing and monitoring PGDM, with periconceptional levels influencing the risk of congenital anomalies and complications. OBJECTIVES: To evaluate the association between periconceptional HbA1c levels and perinatal complications in pregnant women with poorly controlled PGDM. METHODS: We conducted a retrospective analysis of prospectively collected data of pregnancies between 2010 and 2019, HbA1c > 6% at 3 months prior to conception or during the first trimester. Outcomes of periconceptional HbA1c levels were compared. RESULTS: The cohort included 89 women: 49 with HbA1c 6-8%, 29 with HbA1c 8-10%, and 11 with HbA1c > 10%. Higher HbA1c levels were more prevalent in type 1 diabetics and were associated with increased end-organ damage risk. Women with elevated HbA1c levels tended toward unbalanced glucose levels during pregnancy. The cohort exhibited high rates of preterm delivery, hypertensive disorders, cesarean delivery, and neonatal intensive care unit admission. Overall live birth rate was 83%. While a significant correlation was found between HbA1c levels and preterm delivery, no consistent association was observed with other adverse outcomes. CONCLUSIONS: Periconceptional glycemic control in PGDM pregnancies is important. Elevated HbA1c levels are associated with increased risks of adverse outcomes. Beyond a certain HbA1c level, risks of complications may not proportionally escalate.

Long-term Neurobehavioral and Metabolic Outcomes in Offspring of Mothers With Diabetes During Pregnancy: A Large, Population-Based Cohort Study in Ontario, Canada.

OBJECTIVE: Offspring of women with diabetes are at increased risk of developing neurobehavioral and cardiometabolic disorders, but there is scant evidence regarding the association between glycemic level during pregnancy and these long-term offspring outcomes. RESEARCH DESIGN AND METHODS: We conducted a population-based, cohort study of deliveries in Ontario between April 1991 and March 2018. Women had preexisting diabetes, gestational diabetes, or no diabetes. We applied a Cox proportional hazard model to examine the risk of developing attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and cardiometabolic outcomes in offspring and assessed the association between pregnancy HbA1c levels and risk of outcomes, adjusting for confounders. RESULTS: A total of 3,407,961 mother-infant pairs were followed up to 29 years. Using a Cox proportional hazard model, offspring of women with type 1 diabetes had the highest risk of ADHD (adjusted hazard ratio [aHR] 1.43 [95% CI 1.36-1.49]), ASD (aHR 1.94 [1.80-2.09]), diabetes (aHR 4.73 [4.34-5.16]), hypertension (aHR 2.32 [2.07-2.61]), and cardiovascular disease (CVD) (aHR 1.72 [1.56-1.90]), followed by offspring of women with type 2 diabetes and gestational diabetes compared with those unexposed. Among women with preexisting diabetes, there was an association between level of pregnancy HbA1c and offspring diabetes (aHR 1.22 [95% CI 1.12-1.32]), hypertension (aHR 1.42 [1.29-1.57]), and CVD (aHR 1.20 [1.11-1.29]) but no statistically significant association with neurobehavioral outcomes. CONCLUSIONS: In utero exposure to maternal diabetes was associated with an increase in ADHD, ASD, and cardiometabolic outcomes in offspring, with differences seen across diabetes subtypes. Pregnancy glycemia was associated with cardiometabolic outcomes, but not neurobehavioral outcomes, and provides a potentially modifiable risk factor to decrease cardiometabolic outcomes in offspring.

Hemoglobin A1c Trajectories During Pregnancy and Adverse Outcomes in Women With Type 2 Diabetes: A Danish National Population-Based Cohort Study.

OBJECTIVE: To identify and characterize groups of pregnant women with type 2 diabetes with distinct hemoglobin A1c (HbA1c) trajectories across gestation and to examine the association with adverse obstetric and perinatal outcomes. RESEARCH DESIGN AND METHODS: This was a retrospective Danish national cohort study including all singleton pregnancies in women with type 2 diabetes, giving birth to a liveborn infant, between 2004 and 2019. HbA1c trajectories were identified using latent class linear mixed-model analysis. Associations with adverse outcomes were examined with logistic regression models. RESULTS: A total of 1,129 pregnancies were included. Three HbA1c trajectory groups were identified and named according to the glycemic control in early pregnancy (good, 59%; moderate, 32%; and poor, 9%). According to the model, all groups attained an estimated HbA1c <6.5% (48 mmol/mol) during pregnancy, with no differences between groups in the 3rd trimester. Women with poor glycemic control in early pregnancy had lower odds of having an infant with large-for-gestational-age (LGA) birth weight (adjusted odds ratio [aOR] 0.57, 95% CI 0.40-0.83), and higher odds of having an infant with small-for-gestational age (SGA) birth weight (aOR 2.49, 95% CI 2.00-3.10) and congenital malformation (CM) (aOR 4.60 95% CI 3.39-6.26) compared with women with good glycemic control. There was no evidence of a difference in odds of preeclampsia, preterm birth, and caesarean section between groups. CONCLUSIONS: Women with poor glycemic control in early pregnancy have lower odds of having an infant with LGA birth weight, but higher odds of having an infant with SGA birth weight and CM.

Shoulder dystocia in babies born to Aboriginal mothers with diabetes: a population-based cohort study, 1998-2015.

BACKGROUND: Australian Aboriginal and Torres Strait Islander women with diabetes in pregnancy (DIP) are more likely to have glycaemic levels above the target range, and their babies are thus at higher risk of excessive fetal growth. Shoulder dystocia, defined by failure of spontaneous birth of fetal shoulder after birth of the head requiring obstetric maneuvers, is an obstetric emergency that is strongly associated with DIP and fetal size. The aim of this study was to investigate the epidemiology of shoulder dystocia in Aboriginal babies born to mothers with DIP. METHODS: Stratifying by Aboriginal status, characteristics of births complicated by shoulder dystocia in women with and without DIP were compared and incidence and time-trends of shoulder dystocia were described. Compliance with guidelines aiming at preventing shoulder dystocia in women with DIP were compared. Post-logistic regression estimation was used to calculate the population attributable fractions (PAFs) for shoulder dystocia associated with DIP and to estimate probabilities of shoulder dystocia in babies born to mothers with DIP at birthweights > 3 kg. RESULTS: Rates of shoulder dystocia from vaginal births in Aboriginal babies born to mothers with DIP were double that of their non-Aboriginal counterparts (6.3% vs 3.2%, p < 0.001), with no improvement over time. Aboriginal mothers with diabetes whose pregnancies were complicated by shoulder dystocia were more likely to have a history of shoulder dystocia (13.1% vs 6.3%, p = 0.032). Rates of guideline-recommended elective caesarean section in pregnancies with diabetes and birthweight > 4.5 kg were lower in the Aboriginal women (28.6% vs 43.1%, p = 0.004). PAFs indicated that 13.4% (95% CI: 9.7%-16.9%) of shoulder dystocia cases in Aboriginal (2.7% (95% CI: 2.1%-3.4%) in non-Aboriginal) women were attributable to DIP. Probability of shoulder dystocia among babies born to Aboriginal mothers with DIP was higher at birthweights > 3 kg. CONCLUSIONS: Aboriginal mothers with DIP had a higher risk of shoulder dystocia and a stronger association between birthweight and shoulder dystocia. Many cases were recurrent. These factors should be considered in clinical practice and when counselling women.

Diabetes mellitus in pregnancy across Canada.

BACKGROUND: Contemporary estimates of diabetes mellitus (DM) rates in pregnancy are lacking in Canada. Accordingly, this study examined trends in the rates of type 1 (T1DM), type 2 (T2DM) and gestational (GDM) DM in Canada over a 15-year period, and selected adverse pregnancy outcomes. METHODS: This study used repeated cross-sectional data from the Canadian Institute of Health Information (CIHI) hospitalization discharge abstract database (DAD). Maternal delivery records were linked to their respective birth records from 2006 to 2019. The prevalence of T1DM, T2DM and GDM were calculated, including relative changes over time, assessed by a Cochrane-Armitage test. Also assessed were differences between provinces and territories in the prevalence of DM. RESULTS: Over the 15-year study period, comprising 4,320,778 hospital deliveries in Canada, there was a statistically significant increase in the prevalence of GDM and T1DM and T2DM. Compared to pregnancies without DM, all pregnancies with any form of DM had higher rates of hypertension and Caesarian delivery, and also adverse infant outcomes, including major congenital anomalies, preterm birth and large-for-gestational age birthweight. CONCLUSION: Among 4.3 million pregnancies in Canada, there has been a rise in the prevalence of DM. T2DM and GDM are expected to increase further as more overweight women conceive in Canada.

Prematurity and congenital malformations differ according to the type of pregestational diabetes.

BACKGROUND: Diabetes mellitus (DM) is the most common metabolic disorder in pregnancy. Women with Type 2 DM seems to have no better perinatal outcomes than those with Type 1 DM. METHODS: Single-center prospective cohort observational study. Pregnant women with diabetes (141 with Type 1 DM and 124 with Type 2 DM) that were followed in the university hospital between 2009 and 2021 were included in this study. Clinical data and obstetric and perinatal outcomes were collected. RESULTS: As expected, women with Type 1 DM were younger and had a longer duration of diabetes than women with Type 2 DM. Obesity and chronic hypertension were higher in the group of women with Type 2 DM and their value of HbA1c in the second and third trimesters were lower than in Type 1 DM. No differences in prematurity were found, but more extreme prematurity was observed in Type 2 DM, as well as a higher rate of congenital malformations. The frequency of hypoglycemia and the weight of the newborn was higher in Type 1 DM. The maternal independent factors related to the weight of the newborn were: the glycemic control at the third trimester, the weight gain during pregnancy, and pregestational BMI. CONCLUSIONS: Newborns born to mothers with Type 1 DM were larger and had a higher frequency of hypoglycemia, while congenital malformations and precocious preterm was more associated to Type 2 DM. Metabolic control, weight gain and pregestational weight were important determinants of both obstetric and neonatal complications.

Effect of Prenatal Care on Perinatal Outcomes of Pregnant Women with Diabetes Mellitus: A Systematic Review.

Objective: to evaluate the effect of prenatal care (PC) on perinatal outcomes of pregnant women with diabetes mellitus (DM). Methods: systematic review developed according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020 guidelines and conducted through the population, intervention, control, and outcomes (PICO) strategy. Clinical trials and observational studies were selected, with adult pregnant women, single-fetus pregnancy, diagnosis of DM, or gestational DM and who had received PC and/or nutritional therapy (NT). The search was carried out in PubMed, Scopus, and BIREME databases. The quality of the studies was evaluated using the tools of the National Heart, Lung and Blood Institute-National Institutes of Health (NHLBI-NIH). Results: We identified 5972 records, of which 15 (n=47 420 pregnant women) met the eligibility criteria. The most recurrent outcomes were glycemic control (14 studies; n=9096 participants), hypertensive disorders of pregnancy (2; n=39 282), prematurity (6; n=40 163), large for gestational age newborns (4; n=1556), fetal macrosomia (birth weight >4kg) (6; n=2980) and intensive care unit admission (4; n=2022). Conclusions: The findings suggest that PC interferes with the perinatal outcome, being able to reduce the risks of complications associated with this comorbidity through early intervention, especially when the NT is an integral part of this assistance.

Danish Diabetes Birth Registry 2: a study protocol of a national prospective cohort study to monitor outcomes of pregnancies of women with pre-existing diabetes.

INTRODUCTION: Despite technological developments and intensified care, pregnancies in women with pre-existing diabetes are still considered high-risk pregnancies. The rate of adverse outcomes in pregnancies affected by diabetes in Denmark is currently unknown, and there is a limited understanding of mechanisms contributing to this elevated risk. To address these gaps, the Danish Diabetes Birth Registry 2 (DDBR2) was established. The aims of this registry are to evaluate maternal and fetal-neonatal outcomes based on 5 years cohort data, and to identify pathophysiology and risk factors associated with short-term and long-term outcomes of pregnancies in women with pre-existing diabetes. METHODS AND ANALYSIS: The DDBR2 registry is a nationwide 5-year prospective cohort with an inclusion period from February 2023 to February 2028 of pregnancies in women with all types of pre-existing diabetes and includes registry, clinical and questionnaire data and biological samples of mother-partner-child trios. Eligible families (parents age ≥18 years and sufficient proficiency in Danish or English) can participate by either (1) basic level data obtained from medical records (mother and child) and questionnaires (partner) or (2) basic level data and additional data which includes questionnaires (mother and partner) and blood samples (all). The primary maternal outcome is Hemoglobin A1c (HbA1c) levels at the end of pregnancy and the primary offspring endpoint is the birth weight SD score. The DDBR2 registry will be complemented by genetic, epigenetic and metabolomic data as well as a biobank for future research, and the cohort will be followed through data from national databases to illuminate possible mechanisms that link maternal diabetes and other parental factors to a possible increased risk of adverse long-term child outcomes. ETHICS AND DISSEMINATION: Approval from the Ethical Committee is obtained (S-20220039). Findings will be sought published in international scientific journals and shared among the participating hospitals and policymakers. TRIAL REGISTRATION NUMBER: NCT05678543.

Association between extrapolated time in range and large for gestational age infants in pregnant women with type 1 diabetes.

AIMS: To evaluate the association between extrapolated time in range (eTIR), measured by self-monitoring of blood glucose (SMBG), and large-for-gestational-age (LGA) infants in pregnancies with type 1 diabetes (T1D). METHODS: Retrospective cohort analysis including singleton pregnancies with T1D who started antenatal care before 20 gestational weeks and delivered live newborns at a Brazilian hospital between 2010 and 2019, with LGA fetuses as the main outcome. Glycemic records acquired using SMBG were categorized as eTIR, extrapolated time below range (eTBR), and extrapolated time above range (eTAR). Women were divided into two groups (LGA and adequate for gestational age [AGA]) and compared regarding clinical characteristics, obstetric outcomes, and frequencies of eTIR, eTBR, and eTAR. Logistic regression analysis verified the independent predictive variables for LGA infants. RESULTS: Data from 125 pregnancies were analyzed. For the first, second and third trimesters, each 1 % increase in eTIR was associated with a decreased risk of LGA by 2.9 % (OR: 0.971; 95%CI: 0.945-0.998), 2.5 % (OR: 0.975; 95%CI: 0.951-0.999) and 2.3 % (OR: 0.977; 95%CI: 0.955-0.998) and each 1 % increase in eTAR was associated with an increased risk of LGA by 2.7 % (OR: 1.027; 95%CI: 1.005-1.050), 3.9 % (OR: 1.039; 95%CI: 1.014-1.063) and 4.6 % (OR: 1.046; 95%CI: 1.018-1.075), respectively. CONCLUSION: The concept of TIR can be extrapolated to patients undergoing SMBG to assess the risk of LGA infants in pregnant women with T1D.

The IRELAnD study-investigating the role of early low-dose aspirin in diabetes mellitus: a double-blinded, placebo-controlled, randomized trial.

BACKGROUND: Although aspirin therapy is being increasingly advocated with the intention of risk modification for a wide range of pregnancy complications, women with prepregnancy diabetes mellitus are commonly excluded from clinical trials. OBJECTIVE: The primary aim of this study was to examine the effect of aspirin therapy on a composite measure of adverse perinatal outcome in pregnancies complicated by pregestational diabetes mellitus. STUDY DESIGN: A double-blinded, placebo-controlled randomized trial was conducted at 6 university-affiliated perinatology centers. Women with type 1 diabetes mellitus or type 2 diabetes mellitus of at least 6 months' duration were randomly allocated to 150-mg daily aspirin or placebo from 11 to 14 weeks' gestation until 36 weeks. Established vascular complications of diabetes mellitus, including chronic hypertension or nephropathy, led to exclusion from the trial. The primary outcome was a composite measure of placental dysfunction (preeclampsia, fetal growth restriction, preterm birth <34 weeks' gestation, or perinatal mortality). The planned sample size was 566 participants to achieve a 35% reduction in the primary outcome, assuming 80% statistical power. Secondary end points included maternal and neonatal outcomes and determination of insulin requirements across gestation. Data were centrally managed using ClinInfo and analyzed using SAS 9.4. The 2 treatment groups were compared using t tests or chi-square tests, as required, and longitudinal data were compared using a repeated-measures analysis. RESULTS: From February 2020 to September 2022, 191 patients were deemed eligible, 134 of whom were enrolled (67 randomized to aspirin and 67 to placebo) with a retrospective power of 64%. A total of 101 (80%) women had type 1 diabetes mellitus and 25 (20%) had type 2 diabetes mellitus. Reaching the target sample size was limited by the impact of the COVID-19 pandemic. Baseline characteristics were similar between the aspirin and placebo groups. Treatment compliance was very high and similar between groups (97% for aspirin, 94% for placebo). The risk of the composite measure of placental dysfunction did not differ between groups (25% aspirin vs 21% placebo; P=.796). Women in the aspirin group had significantly lower insulin requirements throughout pregnancy compared with the placebo group. Insulin requirements in the aspirin group increased on average from 0.7 units/kg at baseline to 1.1 units/kg by 36 weeks' gestation (an average 83% within-patient increase), and increased from 0.7 units/kg to 1.3 units/kg (a 181% within-patient increase) in the placebo group, over the same gestational period (P=.002). Serial hemoglobin A1c levels were lower in the aspirin group than in the placebo group, although this trend did not reach statistical significance. CONCLUSION: In this multicenter, double-blinded, placebo-controlled randomized trial, aspirin did not reduce the risk of adverse perinatal outcome in pregnancies complicated by prepregnancy diabetes mellitus. Compared with the placebo group, aspirin-treated patients required significantly less insulin throughout pregnancy, indicating a beneficial effect of aspirin on glycemic control. Aspirin may exert a plausible placenta-mediated effect on pregestational diabetes mellitus that is not limited to its antithrombotic properties.

The Examination and Exploration of Diabetes Distress in Pre-existing Diabetes in Pregnancy: A Mixed-methods Study.

OBJECTIVES: Diabetes distress (DD) has been understudied in the pregnancy population. Pregnancy is known to be a complex, highly stressful time for women with diabetes because of medical risks and the high burden of diabetes management. Our aim in this study was to explain and understand DD in women with pre-existing diabetes in pregnancy. METHODS: An explanatory, sequential mixed-methods study was undertaken. The first strand consisted of a cross-sectional study of 76 women with type 1 and type 2 diabetes. A nested sampling approach was used to re-recruit 18 women back into the second strand for qualitative interviews using an interpretive description approach. RESULTS: DD was measured by the validated Problem Area in Diabetes (PAID) scale. A PAID score of ≥40 was positive for distress. DD prevalence was 22.4% in the cross-sectional cohort and the average PAID score was 27.75 (standard deviation 16.08). In the qualitative strand, women with a range of PAID scores (10.0 to 60.0) were sampled for interviews. The majority of these participants described themes of DD in their interviews. Of the 15 women who described DD thematically, only 6 had positive PAID scores. CONCLUSIONS: Integration of the mixed-methods data underscores important meta-inferences about DD in pregnancy, namely that DD was present to a greater degree than the PAID tool is sensitive to. DD was present qualitatively in most of the qualitative sample, despite interviewing women with a range of PAID scores. Future research on a pregnancy-specific DD scale is needed.

Association between infant birth weight and gestational weight gain in Japanese women with diabetes mellitus.

AIMS/INTRODUCTION: In 2021, the guidelines on gestational weight gain (GWG) were revised and increased by 2-3 kg in Japan. This study aimed to investigate whether the revised guidelines would increase the incidence of babies with excessive birth weight in mothers with diabetes. MATERIALS AND METHODS: This retrospective study included 369 deliveries of women with diabetes whose pre-pregnancy body mass index was below 30 kg/m2 between 1982 and 2021. The primary outcome measure was large for gestational age (LGA). We compared the incidence of LGA between women who gained weight within the previous guidelines and women who gained weight within the revised guidelines. We also compared the incidence of macrosomia, preeclampsia, small for gestational age (SGA), and low birth weight. RESULTS: The incidence of LGA was not significantly different between women who gained weight within the revised guidelines and those within the previous guidelines (34.6% [95% confidence interval 25.6-44.6%] for the revised guidelines vs 28.9% [21.6-37.1%] for the previous guidelines; P = 0.246). Neither was the incidence of macrosomia or preeclampsia significantly different (8.7% [4.0-15.8%] vs 5.6% [2.5-10.8%] and 5.8% [2.1-12.1%] vs 6.3% [2.9-11.7%]; P = 0.264 and 0.824, respectively), while women who gained weight within the revised guidelines had a lower incidence of SGA (1.9% [0.2-6.8%] vs 10.6% [6.0-16.8%]; P = 0.001) and low birth weight (1.0% [0.02-5.2%] vs 7.0% [3.4-12.6%]; P = 0.023). CONCLUSIONS: The revised GWG guidelines could be beneficial in women with diabetes in terms of delivering babies with appropriate birth weight.

Urinary Incontinence in the Third Trimester of Pregnancy of Type 1 Diabetic Women.

BACKGROUND: Type 1 diabetes increases the prevalence of urinary incontinence and may be responsible for additional changes to those existing in a regular gestational period. This study aimed to describe the presence and symptoms of urinary incontinence in pregnant women with type 1 diabetes. METHODS: In this Cross-sectional case control study, forty pregnant women in third gestational trimester were allocated in two equal groups - control group (CG) and type 1 diabetic group (1DMG). The patients answered the International Consultation on Incontinence Questionnaire Short Form and, to characterize the sample, they answered the Pregnancy Physical Activity Questionnaire, gynecological history and, after delivery, the newborn weight was registered. The groups were compared using the Student's T Test for parametric variables and the U-Mann Whitney Test for non-parametric variables, both at 5% probability. RESULTS: The International Consultation on Incontinence Questionnaire Short Form score (p = 0.026) is higher in 1DMG (3.95 ± 4.70) compared to CG (1.05 ± 2.23). No correlations were found between time of diagnosis, HbA1c and newborn weight in relation to ICIQ-SF and other variables in CG and 1DMG with ICIQ-SF (p < 0.05). CONCLUSION: Type 1 diabetes mellitus, in the third trimester of gestation, seem to be associated with increase in the ICIQ-SF score.

HIGHLIGHTS: No correlation between gestational characteristics and urinary incontinence symptoms.The diabetic women group had more episiotomies and abortions.The diabetic women had higher scores in the total score of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).

Preterm delivery and maternal obesity remain common complications in pregnancies with type 1 diabetes-A nationwide study in Sweden.

AIM: A primary goal of obstetric care of women with type 1 diabetes (T1D) is to reduce the risks of preterm birth (PTB). Besides hyperglycaemia, maternal obesity is an important risk factor for PTB in T1D. However, it's unclear if public health efforts decreased risks of maternal obesity and PTB in pregnancies with T1D. We examined time-trends over the last 20 years in the distribution of gestational ages at birth (GA) in offspring of women with T1D in Sweden, and in maternal BMI in the same mothers. METHODS: Population-based cohort study, using data from national registries in Sweden. To capture differences not only in the median values, we used quantile regression models to compare the whole distributions of GA's and early pregnancy BMI between deliveries in 1998-2007 (P1) and 2008-2016 (P2). Multivariable models were adjusted for differences in maternal age, smoking and education between periods 1 and 2. RESULTS: The study included 7639 offspring of women with T1D between 1998 and 2016. The 10% percentile GA, increased with 0.09 days (95% CI: -0.11 to 0.35) between P1 and P2. The 90% percentile for BMI was 1.20 kg/m2 higher (95% CI: 0.57 to 1.83) in P2. Risks of PTB remained stable over time also when adjusting for maternal BMI. CONCLUSION: Despite modern diabetes management, the distribution of GA, and consequently the risk of PTB in T1D, remained unchanged from 1998 to 2016. During the same time, maternal BMI increased, particularly in the already obese.