Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial.

AIM: To investigate the association between continuous glucose monitoring (CGM) metrics and perinatal outcomes in insulin-treated diabetes mellitus in pregnancy. MATERIALS AND METHODS: In a post-hoc analysis of the GlucoMOMS randomized controlled trial, we investigated the association between the metrics of an offline, intermittent CGM, glycated haemoglobin (HbA1c) and perinatal outcomes per trimester in different types of diabetes (type 1, 2 or insulin-treated gestational diabetes mellitus [GDM]). Data were analysed using multivariable binary logistic regression. Outcomes of interest were neonatal hypoglycaemia, pre-eclampsia, preterm birth, large for gestational age (LGA) and Neonatal Intensive Care Unit (NICU) admission. The glucose target range was defined as 3.5-7.8 mmol/L (63-140 mg/dL). RESULTS: Of the 147 participants (N = 50 type 1 diabetes, N = 94 type 2 diabetes/insulin-treated GDM) randomized to the CGM group of the GlucoMOMS trial, 115 participants had CGM metrics available and were included in the current study. We found that, in pregnancies with type 1 diabetes, a higher second trimester mean glucose was associated with LGA (odds ratio 2.6 [95% confidence interval 1.1-6.2]). In type 2 and insulin-treated gestational diabetes, an increased area under the curve above limit was associated with LGA (odds ratio 10.0 [95% confidence interval 1.4-72.8]). None of the CGM metrics were associated with neonatal hypoglycaemia, pre-eclampsia, shoulder dystocia, preterm birth and NICU admission rates for pregnancies complicated by any type of diabetes. CONCLUSION: In this study, in type 2 diabetes or insulin-treated GDM, the glucose increased area under the curve above limit was associated with increased LGA. In type 1 diabetes, the mean glucose was the major determinant of LGA. Our study found no evidence that other CGM metrics determined adverse pregnancy outcomes.

Estimated impact of introduction of new diagnostic criteria for gestational diabetes mellitus.

BACKGROUND: Implementation of new diagnostic criteria for gestational diabetes mellitus (GDM) are still a subject of debate, mostly due to concerns regarding the effects on the number of women diagnosed with GDM and the risk profile of the women newly diagnosed. AIM: To estimate the impact of the World Health Organization (WHO) 2013 criteria compared with the WHO 1999 criteria on the incidence of gestational diabetes mellitus as well as to determine the diagnostic accuracy for detecting adverse pregnancy outcomes. METHODS: We retrospectively analyzed a single center Dutch cohort of 3338 women undergoing a 75 g oral glucose tolerance test where the WHO 1999 criteria to diagnose GDM were clinically applied. Women were categorized into four groups: non-GDM by both criteria, GDM by WHO 1999 only (excluded from GDM), GDM by WHO 2013 only (newly diagnosed) and GDM by both criteria. We compared maternal characteristics, pregnancy outcomes and likelihood ratios for adverse pregnancy outcomes. RESULTS: Retrospectively applying the WHO 2013 criteria increased the cohort incidence by 13.1%, from 19.3% to 32.4%. Discordant diagnoses occurred in 21.3%; 4.1% would no longer be labelled as GDM, and 17.2% were newly diagnosed. Compared to the non-GDM group, women newly diagnosed were older, had higher rates of obesity, higher diastolic blood pressure and higher rates of caesarean deliveries. Their infants were more often delivered preterm, large-for-gestational-age and were at higher risk of a 5 min Apgar score < 7. Women excluded from GDM were older and had similar pregnancy outcomes compared to the non-GDM group, except for higher rates of shoulder dystocia (4.3% vs 1.3%, P = 0.015). Positive likelihood ratios for adverse outcomes in all groups were generally low, ranging from 0.54 to 2.95. CONCLUSION: Applying the WHO 2013 criteria would result in a substantial increase in GDM diagnoses. Newly diagnosed women are at increased risk for pregnancy adverse outcomes. This risk, however, seems to be lower than those identified by the WHO 1999 criteria. This could potentially influence the treatment effect that can be achieved in this group. Evidence on treatment effects in newly diagnosed women is urgently needed.

Adverse maternal and perinatal pregnancy outcomes related to very advanced maternal age in primigravida and multigravida in the Netherlands: A population-based cohort.

INTRODUCTION: The age at which women give birth is rising steadily in the western world. Advanced maternal age has been associated with adverse pregnancy outcomes. We assessed the association between advanced maternal age and the risk of adverse maternal and perinatal outcome in primigravid and multigravid women. MATERIAL AND METHODS: The study was a population-based cohort study and included women giving birth between January 2000 and December 2018 using data from the Dutch perinatal registration of Perined. Women were divided into age groups. We compared outcomes between women of 40-44, 45-49, and over 50 years old (the study groups) with women of 25-29 years old (reference group), stratified for parity. We employed multivariable regression to correct for possible confounders including methods of conception, multiple pregnancies, ethnicity, and socio-economic status. Our primary outcomes were maternal and perinatal mortality. Secondary outcomes included common maternal and perinatal complications, as well as cesarean section rate. RESULTS: A cohort of 3 700 326 women gave birth during the study period. Of these women, 3.2% were above 40 years of age. Maternal mortality was rare in all groups, but significantly higher in multigravid women over 50 years old. Perinatal mortality was significantly higher in all pregnancies of women over 40 years old, but not for primigravida over 50 years old. The most notable results with the steepest increase were in maternal complications. Both primigravida and multigravida over 40 years old were at a two times higher risk of perinatal mortality, cesarean section, gestational diabetes, hypertensive disorders, and a low Apgar score after 5 minutes. The risk for women over 45 was almost tripled for perinatal mortality and gestational diabetes and six times higher for cesarean section. Women over 50 years old had a seven times higher risk of cesarean section, a four times higher risk of gestational diabetes, postpartum hemorrhage, and neonatal intensive care unit admission, and a 10 times higher risk of hypertensive disorders. CONCLUSIONS: The risk of adverse maternal and perinatal outcomes for women over 40 years old surges as age increases. A novel aspect was the consistent increased risks not only for primigravid women but also for multigravida.

SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial.

INTRODUCTION: In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. METHODS: The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NTR6134; Pre-results.

Vaginal or laparoscopic hysterectomy: Do perioperative outcomes differ? A propensity score-matched analysis.

INTRODUCTION: There are assertions that vaginal mode may be the preferred approach of minimally invasive hysterectomy, yet rates of laparoscopic hysterectomy (LH) continue to rise while vaginal hysterectomy (VH) rate remains relatively unchanged. The aim of this study is to compare the perioperative outcomes of LH vs VH. MATERIAL AND METHODS: We identified women who underwent either LH or VH for benign indications between 2009 and 2015 at a large academic institution. A propensity score-matched analysis was used to adjust for differences between women undergoing VH vs LH. Outcome parameters were perioperative complications (both intraoperative and postoperative), operative time, blood loss, hospital length of stay, conversion and readmission. RESULTS: A total of 1921 patients underwent either LH or VH during the study period. In all, 155 patients from each group were successfully matched using propensity score match analysis. While most intra- and postoperative characteristics did not differ between groups, LH was associated with lower blood loss during surgery (102.8 ± 166.5 mL vs 185.0 ± 179.0 mL, P < 0.001) and shorter hospital stay (0.9 ± 1 days vs 1.2 ± 0.9 days, P < 0.0001). Concomitant adnexal surgery was performed more frequently during LH (47.7% vs 12.3%, P < 0.0001), and concomitant prolapse surgery was performed more frequently at the time of VH (14.2% vs 68.4%, P < 0.0001). CONCLUSIONS: Both VH and LH have overall favorable perioperative outcomes; however, LH is associated with lower blood loss and a shorter hospital stay. The results support the trend toward increasing rates of laparoscopic approach to hysterectomy when appropriate.

Essure Removal for the Treatment of Device-Attributed Symptoms: An Expanded Case Series and Follow-up Survey.

STUDY OBJECTIVE: To evaluate perioperative outcomes and symptom resolution in women undergoing removal of the Essure device for device-attributed symptoms. DESIGN: Retrospective case series and follow-up patient survey (Canadian Task Force classification III). SETTING: Large academic medical center. PATIENTS: Fifty-two women who underwent laparoscopic or hysteroscopic Essure removal between 2012 and 2016. INTERVENTIONS: Women underwent one of four procedures: laparoscopic hysterectomy (LH) and bilateral salpingectomy (BS), laparoscopic BS and cornuectomy, laparoscopic Essure removal and BS, or hysteroscopic Essure removal and laparoscopic BS. MEASUREMENTS AND MAIN RESULTS: Fifty-two women who underwent Essure removal were asked to complete a survey regarding symptom resolution and quality of life following the procedure. Thirty-two women (61.5%) responded to the survey. Seventy-five percent (24/32) reported almost total or total improvement in quality of life, 56.3% (18/32) for sex life, 53.1% (17/32) for pelvic pain, and 65.6% (21/32) for daily activities. The majority of women reported some degree of improvement in all four domains queried (87.5%, 28/32). When asked about their symptoms in general, 31.3% (10/32) of women reported ongoing or worse symptoms after Essure removal. All procedures took approximately one hour (mean 65 min, SD 33 min), were associated with minimal blood loss (mean 31 mL, SD 17), and had no perioperative complications. CONCLUSION: Essure removal is a procedure that may be effective for treating most women with symptoms attributed to the device. Patients should be counseled that some symptoms may persist or even worsen following surgery.