SPAM-sub partual analgesia with meptazinol: a prospective cohort study comparing intramuscular with intravenous administration.

PURPOSE: Safe and effective analgesia sub partu is one of the central issues in optimizing vaginal delivery birth experiences. Meptazinol is a common opiate approved for treating labor pain in the first stage of labor. According to the manufacturer, manual meptazinol can be applied intramuscularly or intravenously. The aim of this study was to compare the two application methods in terms of efficacy in pain relief, occurrence of side effects and treatment satisfaction. METHODS: 132 patients with singleton term pregnancies and intended vaginal delivery, receiving meptazinol during first stage of labor were included in this prospective cohort study from 05/2020 to 01/2021. We evaluated effectiveness in pain relief and treatment satisfaction using numeric rating scales (NRS) and documented the occurrence of adverse effects. Chi-square test or Fisher exact test were used to compare categorical data and Mann-Whitney U test to compare continuous data between the two treatment groups. Statistical analysis was done by SPSS 27.0. A p value < 0.05 was considered to indicate statistical significance (two tailed). RESULTS: Meptazinol decreased labor pain significantly from a NRS of 8 (IQR 8-10) to 6 (IQR 4.75-8) in both treatment groups with no difference in effectiveness between the groups. Frequency of effective pain reduction of a decrease of 2 or more on the NRS did not differ between groups (39.4% vs 54.5%, p = 0.116), as the occurrence of adverse effects. 12% of the newborns were admitted to NICU, the median NApH was 7.195. CONCLUSION: Meptazinol significantly reduces labor pain regardless of the method of application: intramuscular or intravenous. According to our data, no preferable route could be identified. The comparably poorer perinatal outcome in our study cohort hinders us to confirm that meptazinol is safe and can be recommended without restrictions.

Disease Perception and Mental Health in Pregnancies with Gestational Diabetes-PsychDiab Pilot Study.

(1) Background: The aim of this work is to investigate the extent to which pregnant women's well-being is burdened by the diagnosis of gestational diabetes, as well as their sensitivities and illness perceptions. Since gestational diabetes is associated with mental disorders, we hypothesized that the burden of illness might be related to pre-existing mental distress. (2) Methods: Patients treated for gestational diabetes in our outpatient clinic were retrospectively asked to complete a survey, including the self-designed Psych-Diab-Questionnaire to assess treatment satisfaction, perceived limitations in daily life and the SCL-R-90 questionnaire to assess psychological distress. The association between mental distress and well-being during treatment was analyzed. (3) Results: Of 257 patients invited to participate in the postal survey, 77 (30%) responded. Mental distress was found in 13% (n = 10) without showing other relevant baseline characteristics. Patients with abnormal SCL-R-90 scores showed higher levels of disease burden, were concerned about glucose levels as well as their child's health, and felt less comfortable during pregnancy. (4) Conclusions: Analogous to the postpartum depression screening, screening for mental health problems during pregnancy should be considered to target psychologically distressed patients. Our Psych-Diab-Questionnaire has been shown to be suitable to assess illness perception and well-being.

Obesity during Pregnancy and SARS-CoV-2/COVID-19-Case Series of the Registry Study "COVID-19 Related Obstetric and Neonatal Outcome Study" (CRONOS-Network).

(1) Background: Obesity is an increasing challenge in the care of pregnant women. The aim of our study was to investigate whether obesity is an independent risk factor for severe maternal and neonatal outcomes in pregnant women with COVID-19. (2) Methods: Data from the COVID-19 Related Obstetric and Neonatal Outcome Study (CRONOS), a prospective multicenter registry for SARS-CoV-2 positive pregnant women, was used to analyze the effect of obesity on selected individual and combined outcome parameters (3) Results: With 20.1%, the prevalence of obesity in the CRONOS registry exceeds the German background rate of 17.5%. Obese women showed significantly higher rates of GDM (20.4% vs. 7.6%; p < 0.001), hypertensive pregnancy disorders (6.2% vs. 2%; p = 0.004) and C-sections (50% vs. 34.5%; p < 0.001). BMI was revealed to be an individual risk factor for the severe combined pregnancy outcome (maternal death, stillbirth or preterm birth < 32 weeks) (OR 1.050, CI 1.005-1.097). (4) Conclusions: Maternal BMI is a predictor for the most severe outcome as maternal or neonatal death and preterm delivery <32 weeks of gestation. Unexpectedly, categorized obesity seems to have limited independent influence on the course and outcome of pregnancies with COVID infections.

Using flash glucose monitoring in pregnancies in routine care of patients with gestational diabetes mellitus: a pilot study.

AIM: Flash glucose monitoring (FGM) has been approved for the care of pregnant women with preexisting diabetes since 2017. However, its use in gestational diabetes (GDM) has been critically discussed. Inaccuracy and missing recommendations for target values are the main arguments against the use of FGM in GDM. To date, there is a lack of data to justify routine use of FGM in GDM pregnancies. Consequently, this new technology has been withheld from GDM-patients. Aim of our pilot study was to analyze the impact of FGM use on pregnancy outcomes, patient's satisfaction and to confirm the safe use in GDM pregnancies. METHODS: Cohort study of 37 FGM-managed GDM pregnancies compared with 74 matched women using self-monitoring of blood glucose (SMBG). Group comparison using nonparametric testing concerning patients characteristic and perinatal outcome focusing on adverse outcomes (preeclampsia, preterm delivery, large for gestational age, C-sections, neonatal intensive care unit admission, hyperbilirubinemia and hypoglycemia). Evaluation of patient's treatment satisfaction using the "Diabetes Treatment Satisfaction Questionnaire change" (DTSQc) and patient interviews. RESULTS: No significant differences in patient's characteristics despite gestational age at diagnosis (FGM with 20 vs. SMBG with 25 weeks). No difference in gestational weight gain, HbA1c progression and perinatal outcome. Treatment satisfaction obtained by the DTSQc revealed a high level of satisfaction with FGM use. CONCLUSION: FGM use was well accepted and did not affect perinatal outcome. Use of FGM during pregnancy is safe and non-inferior to the management with SBGM. FGM should be considered as an option in the management of GDM patients.

[SARS-CoV-2/COVID-19 and Hypertensive Pregnancy Disorders: Evaluation of the CRONOS National Registry]. / Hypertensive Schwangerschaftserkrankungen und SARS-CoV-2/COVID-19: Auswertung des nationalen CRONOS-Registers.

SARS-CoV-2 infection and COVID-19 disease are associated with an increased risk of hypertensive pregnancy disease in international registry studies. Preexisting hypertensive disorders are recognized as a risk factor of severe COVID-19 progression in pregnancy. The respective damage to the endothelium is discussed as a pathophysiological commonality of both diseases.Data of the national CRONOS registry (data status 05/2021; 1104 pregnant women with SARS-CoV-2 infection) were analyzed regarding the association of hypertensive pregnancy disease and maternal, pregnancy, neonatal, and COVID-19 disease outcomes. In the presence of hypertensive pregnancy disease, a severe combined outcome of pregnancy (17.3 vs. 4.3%, p=0.001), mother (25.0 vs. 9.4%, p=0.001), and newborn (28.8 vs. 9.1%, p<0.0005) occurred significantly more frequent. In contrast, the outcome of COVID-19 disease did not differ (3.8 vs. 7.5%, p=0.424). The co-occurrence of SARS-CoV-2 infection and hypertensive pregnancy disease should be acknowledged as risk factor during management decisions.

Induction of Labor at Term with Oral Misoprostol or as a Vaginal Insert and Dinoprostone Vaginal Insert - A Multicenter Prospective Cohort Study.

Introduction The efficacy, safety, and perinatal outcome of oral misoprostol (OM), a misoprostol vaginal insert (MVI), and a dinoprostone vaginal insert (DVI) for induction of labor at term was examined in a prospective multicenter cohort study (ethics committee vote 4154-07/14). The primary aims of the study were the induction-birth interval (IBI), the cumulative delivery rates after 12 h, 24 h, and 48 h as well as the mode of delivery. Method 322 pregnant women were included in four German tertiary perinatal centers (MVI 110, DVI 64, OM 148). They did not vary in age or BMI. Statistical analysis was carried out using a multivariate linear regression analysis and binary logistic regression analysis. Results With regards to the median IBI, MVI and OM were equally effective and superior to the DVI (MVI 823 min [202, 5587]; DVI 1226 min [209, 4909]; OM 847 min [105, 5201]; p = 0.006). Within 24 hours, 64% were able to deliver with DVI, 85.5% with MVI and 87.5% with OM (p < 0.01). The rates of secondary Caesarean sections (MVI 24.5%; DVI 26.6%; OM 18.9%) did not differ significantly. Uterine tachysystole was found in 20% with MVI, 4.7% with DVI and 1.4% with OM (p < 0.001). A uterine rupture did not occur in any of the cases. Perinatal acidosis occurred (umbilical cord arterial pH < 7.10) in 8.3% with MVI, 4.7 with DVI and 1% with OM (p = 0.32). Neonatal condition was only impaired in three cases (5-minute Apgar score < 5). Summary Induction of labor at term using the prostaglandins misoprostol and dinoprostone is an effective intervention that is safe for the mother and child. Oral application of misoprostol demonstrated the highest efficacy while maintaining a favorable safety profile.

Inadequate Timing Limits the Benefit of Antenatal Corticosteroids on Neonatal Outcome: Retrospective Analysis of a High-Risk Cohort of Preterm Infants in a Tertiary Center in Germany.

Introduction A common problem in the treatment of threatened preterm birth is the timing and the unrestricted use of antenatal corticosteroids (ACS). This study was performed to evaluate the independent effects of the distinct timing of antenatal corticosteroids on neonatal outcome parameters in a cohort of very low (VLBW; 1000 - 1500 g) and extreme low birth weight infants (ELBW; < 1000 g). We hypothesize that a prolonged ACS-to-delivery interval leads to an increase in respiratory complications. Materials and Methods Main data source was the prospectively collected single center data for the German nosocomial infection surveillance system (KISS) between 2015 and 2018. Multivariate regression analysis was performed to determine independent effects of the ACS-to-delivery interval on the need for ventilation, surfactant or the occurrence of bronchopulmonary dysplasia, neonatal sepsis or necrotizing enterocolitis. Subgroup analysis was performed for ELBW and VLBW neonates. Results A total of 239 neonates were included. We demonstrate a significantly increased risk of respiratory distress characterized by the need for ventilation (OR 1.045; CI 1.011 - 1.080) and surfactant administration (OR 1.050, CI 1.018 - 1.083) depending on the ACS-to-delivery interval irrespective of other confounders. Every additional day between ACS and delivery increased the risk for ventilation by 4.5% and for surfactant administration by 5%. Subgroup analysis revealed significant differences of respiratory complications in VLBW infants. Conclusions Our data strongly support the deliberate use and timing of antenatal corticosteroids in pregnancies with threatened preterm birth versus a liberal strategy. When given more than 7 days before birth, each day between application and delivery increases is relevant concerning major effects on the infant. Especially VLBW preterm neonates benefit from optimal timing.

Predictors of a successful vaginal delivery in women with type 1 diabetes: a retrospective analysis of 20 years.

PURPOSE: To evaluate the independent factors associated with the success of a trial of vaginal birth (TVB) in women with type 1 diabetes. Despite all therapeutic efforts and technological innovations, rates of caesarean sections (CS) in pregnant women with type 1 diabetes remain unchanged above 60%. Our aim was to point out influencing factors to improve the quality of antepartum counseling. METHODS: We performed a retrospective cohort study of 195 pregnancies with type 1 diabetes treated between 2000 and 2019. After exclusions, 118 women with near-term singleton pregnancies intended vaginal birth (TVB). Group differences between CS and successful vaginal delivery were analyzed. Multivariate logistic regression was performed by including clinical and metabolic variables to determine the independent effects on a successful vaginal delivery. Subgroup analysis for nulliparous women. RESULTS: Of 118 women with TVB, 67 (56.8%) were delivered vaginally. History of previous vaginal delivery (OR 10.29; CI 2.39; 44.30), HbA1c changes during pregnancy (per % increase; OR 0.59; CI 0.36; 0.96) and gestational weight gain (per kg; OR 0.87; CI 0.80; 0.96) were independent predictors for a successful vaginal delivery. In nulliparous women, the duration of diabetes was independently and negatively associated with vaginal delivery. CONCLUSION: Provided data can help to improve antepartum counseling in type 1 diabetic patients. It seems that women with type 1 diabetes should avoid postponing pregnancy and childbirth.

Predictors of Treatment Requirements in Women with Gestational Diabetes: A Retrospective Analysis.

The diagnosis of gestational diabetes is usually very stressful for pregnant women, especially because they fear that insulin treatment may become necessary. Knowledge about personal risk factors predicting the probability of insulin treatment could therefore help to improve acceptance of the diagnosis and therapy adherence. The aim of this study was to find potential risk factors for insulin dependency and treatment requirements using information available at the time of diagnosis of gestational diabetes during pregnancy. We included 454 singleton pregnancies diagnosed ≥24 weeks of gestation. Multivariate regression analysis was used to evaluate independent associations of metabolic, anthropometric and fetal ultrasound parameters with the general need for insulin treatment and further stratified treatment options: diet (n = 275), bolus insulin only (n = 45), basal insulin only (n = 73) and multiple daily injections (n = 61). Receiver operator characteristics and cut-off values for independent variables were generated. Treatment groups differed significantly concerning pre-pregnancy weight and BMI as well as fasting glucose and 1 h glucose test values. Significant cut-offs for insulin dependency were HbA1c level of 5.4%, FPG of 5.5 mmol/L and 1 h glucose of 10.6 mmol/L. At time of diagnosis, certain patient characteristics and measurements can help to predict treatment necessities and therefore improve individualized counselling.

The Relationship between Gestational Diabetes Metabolic Control and Fetal Autonomic Regulation, Movement and Birth Weight.

(1) Background: Maternal metabolic control in gestational diabetes is suggested to influence fetal autonomic control and movement activity, which may have fetal outcome implications. We aimed to analyze the relationship between maternal metabolic control, fetal autonomic heart rate regulation, activity and birth weight. (2) Methods: Prospective noninterventional longitudinal cohort monitoring study accompanying 19 patients with specialist clinical care for gestational diabetes. Monthly fetal magnetocardiography with electro-physiologically-based beat-to-beat heart rate recording for analysis of heart rate variability (HRV) and the 'fetal movement index' (FMI) was performed. Data were compared to 167 healthy pregnant women retrieved from our pre-existing study database. (3) Results: Fetal vagal tone was increased with gestational diabetes compared to controls, whereas sympathetic tone and FMI did not differ. Within the diabetic population, sympathetic activation was associated with higher maternal blood-glucose levels. Maternal blood-glucose levels correlated positively with birth weight z scores. FMI showed no correlation with birth weight but attenuated the positive correlation between maternal blood-glucose levels and birth weight. (4) Conclusion: Fetal autonomic control is altered by gestational diabetes and maternal blood-glucose level, even if metabolic adjustment and outcome is comparable to healthy controls.

Awareness of euglycaemic diabetic ketoacidosis during pregnancy prevents recurrence of devastating outcomes: a case report of two pregnancies in one patient.

BACKGROUND: Euglycaemic diabetic ketoacidosis (DKA) during pregnancy is a life-threatening obstetric emergency. It requires early identification and prompt action. Obstetricians' knowledge about symptoms, diagnostic pitfalls and management during pregnancy and delivery need to be improved. We report a case of a young diabetic woman developing severe euglycaemic DKA in two consecutive pregnancies; the first pregnancy resulted in the most deviating outcome (i.e., intrauterine death), while the second pregnancy resulted in the delivery of a healthy newborn. Thus, the novelty of the case presented here is the possibility to demonstrate how the management of DKA in pregnancy can dramatically change outcomes. CASE PRESENTATION: We report a case of a young diabetic woman in whom DKA was concealed by hyperemesis and oesophageal reflux. This woman presented to our delivery unit with severe euglycaemic DKA during her first pregnancy. While the mother's condition could be successfully stabilized, the foetus died shortly after admission. Two years later, the same woman presented with similar problems. Repeated episodes of mild euglycaemic DKA could be successfully managed with consequent interdisciplinary treatment and close observation, leading to a good pregnancy outcome, i.e., the birth of a healthy child. CONCLUSION: Awareness of euglycaemic DKA needs to be increased to reduce the risk of severe complications during pregnancies in diabetic women. This case report demonstrates that increased awareness of DKA with immediate recognition and a successful multidisciplinary approach are mandatory for an positive pregnancy outcomes.

Circadian rhythm and gestational diabetes: working conditions, sleeping habits and lifestyle influence insulin dependency during pregnancy.

OBJECTIVE: Management of gestational diabetes (GDM) is currently changing toward a more personalized approach. There  is a growing number of GDM patients requiring only a single dose of basal insulin at night to achieve glucose control. Well-known risk factors like obesity, parity and family history have been associated with GDM treatment requirements. Sleep quality and lifestyle factors interfering with the circadian rhythm are known to affect glucose metabolism. The aim of this study was to investigate the impact of such lifestyle factors on insulin requirement in GDM patients, in particular on long-acting insulin to control fasting glucose levels. RESEARCH DESIGN AND METHODS: A total of 805 patients treated for GDM between 2012 and 2016 received a study questionnaire on lifestyle conditions. Sleep quality and work condition categories were used for subgroup analysis. Independent effects on treatment approaches were evaluated using multivariate regression. RESULTS: In total, 235 (29.2%) questionnaires returned. Women reporting poor sleep conditions had higher pre-pregnancy weight and BMI, heavier newborns, more large for gestational age newborns and higher rates of hyperbilirubinemia. Treatment requirements were related to sleep and work condition categories. Multivariate regression for 'Basal' insulin-only treatment revealed an adjOR 3.4 (CI 1.23-9.40, p < 0.05) for unfavorable work conditions and adjOR 4.3 (CI 1.28-14.50, p < 0.05) for living with children. CONCLUSIONS: Our findings suggest that external stressors like unfavorable work conditions and living with children are independently associated with the necessity of long-acting insulin at night in GDM patients. Thus, fasting glucose levels of pregnant women presenting with such lifestyle conditions may be subject to close monitoring.

Contributing Factors to Perinatal Outcome in Pregnancies with Gestational Diabetes-What Matters Most? A Retrospective Analysis.

The aim of diabetes care of pregnant women with gestational diabetes mellitus (GDM) is to attain pregnancy outcomes including rates of large-for-gestational-age (LGA) newborns, pre-eclampsia, C-sections (CS) and other neonatal outcomes similar to those of the non-GDM pregnant population. Obesity and excessive weight gain during pregnancy have been shown to also impact perinatal outcome. Since GDM is frequently associated with elevated body mass index (BMI), we evaluated the impact of maternal prepregnancy BMI, development of GDM and gestational weight gain (GWG) during pregnancy on perinatal outcome. We compared 614 GDM patients with 5175 non-diabetic term deliveries who gave birth between 2012 and 2016. Multivariate regression analysis was used to evaluate the independent contribution of each factor on selected perinatal outcome variables. Additionally, subgroup analysis for obese (BMI ≥ 30 kg/m2) and non-obese women (BMI < 30 kg/m2) was performed. LGA was significantly influenced by BMI, GWG and GDM, while Neonatal Intensive Care Unit (NICU) admission was solely impacted by GDM. Maternal outcomes were not dependent on GDM but on GWG and prepregnancy BMI. These results remained significant in the non-obese subgroup only. Thus, GDM still affects perinatal outcomes and requires further improvement in diabetic care and patient counseling.

NUT midline carcinoma in a young pregnant female: a case report.

INTRODUCTION: The NUT midline carcinoma is a rare tumor mostly reported in the midline of upper aerodigestive tract and mediastinum. Children as well as adolescents are affected without a gender distribution. A standard treatment is not established. So far, there exists no reported case of a pregnant female suffering from NUT midline carcinoma with musculoskeletal manifestation. CASE PRESENTATION: A 34-year-old woman was referred to our outpatient clinic by the general practitioner during her 31st week of pregnancy suffering from shoulder pain and dyspnea. So far, dyspnea was interpreted as a typical pregnancy-related symptom. However, a chest X-ray showed a tumor mass in the right lung in close relation to the scapula. Further examinations found metastases in different areas of the body. No pregnancy-related complications were detected by obstetric examination. After an interdisciplinary perinatal case discussion, cesarean section was directly followed by an open biopsy of the right side scapula tumor lesion. A NUT midline carcinoma was diagnosed by immunohistochemistry. Due to disseminated tumor disease in multiple non-resectable locations, a palliative systemical chemotherapy was started by the oncological outpatient clinic. CONCLUSION: This report presents the case of the very rare NUT midline carcinoma under pregnancy which made interdisciplinary case discussions indispensable for therapy planning.

The Relevance of Fetal Abdominal Subcutaneous Tissue Recording in Predicting Perinatal Outcome of GDM Pregnancies: A Retrospective Study.

Guidelines on the management of gestational diabetes (GDM) instruct physicians to involve ultrasound-based monitoring of fetal growth in addition to blood glucose. So far, glucose control besides clinical parameters like maternal body mass index (BMI) and gestational weight gain have been shown to predict neonatal outcome. We aimed to evaluate the discriminative ability of fetal abdominal subcutaneous tissue (FAST) in addition to standard ultrasound parameters like abdominal circumference (AC) and estimated fetal weight (EFW) for perinatal complications like large for gestational age (LGA), hypoglycemia, hyperbilirubinemia, mode of delivery and admission to neonatal intensive care unit (NICU). Ultrasound data and neonatal outcome was collected of 805 GDM cases from 2012 to 2016: 3205 FAST, 3195 AC-measurements and 3190 EFW calculations were included. AC, EFW and FAST increased linear with gestational age. Combining ultrasound and clinical parameters improved predictive power for LGA. In the subgroup where fetuses grow with an AC > 75th additional adding of FAST to standard ultrasound parameters increased predictive power for hypoglycemia. Our results confirm inclusion of ultrasound parameters to be beneficial in monitoring GDM pregnancies. Additional FAST determination revealed to be of potential clinical relevance in the subgroup AC > 75th percentile.

Gestational Weight Gain Particularly Affects the Risk of Large for Gestational Age Infants in Non-obese Mothers.

Introduction The birth of a large for gestational age (LGA) infant is a significant risk factor for birth complications and maternal morbidity and an even higher risk factor for offspring obesity, metabolic syndrome and cardiovascular disease in later life. Relevant factors affecting the risk of delivering an LGA infant are maternal pre-gravid obesity, excessive gestational weight gain exceeding the recommendations of the Institute of Medicine (IOM) and diabetes in pregnancy. We aimed to determine what matters most in terms of the risk of fetal overgrowth. Materials and Methods We performed a database analysis of 12 701 singleton term deliveries documented in our university hospital birth registry from 2003 to 2014. Multivariate logistic regression analysis was used to determine the adjusted odds ratios. Results Excessive weight gain had the strongest impact on LGA (OR: 1.249 [95% CI: 1.018 - 1.533]) compared to maternal pre-gravid body mass index (BMI) (OR: 1.083 [95% CI: 1.066 - 1.099]) and diabetes (OR: 1.315 [95% CI: 0.997 - 1.734]). Keeping gestational weight gain within the recommendations of the IOM resulted in a risk reduction for LGA of 20% (OR: 0.801 [95% CI: 0.652 - 0.982]). The risk for LGA increases by 6.9% with each kg weight gain. Normal weight women (BMI 18.5 - 24.9 kg/m 2 ) and moderately overweight women (BMI 25 - 29.9 kg/m 2 ) showed the highest increase in LGA rates per kg weight gain during pregnancy (OR: 1.078 [95% CI: 1.052 - 1.104] and OR: 1.058 [95% CI: 1.026 - 1.09], resp.). Only in underweight (< 18.5 kg/m 2 ) and normal weight women the risk of LGA birth is strongly influenced by diabetes (OR 11.818 [95% CI: 1.156-120.782] and 1.564 [95% CI: 1.013-2.415]). Conclusion Excessive weight gain is particularly important for non-obese women. These women are therefore a target cohort for intervention, as each prevented additional kilogram weight gain reduces the risk of LGA by more than 5%.