MINIMIZING TEARING DURING VAGINAL DELIVERY WITH A PERINEAL PROTECTION DEVICE - A RANDOMIZED CONTROLLED TRIAL.

BACKGROUND: There is a growing body of evidence indicating that second degree tears cause both short-, and long-term consequences. Very few preventative measures have been found to reduce the incidence of these tears. OBJECTIVE: To investigate if the use of a perineal protection device during vaginal birth reduces severe perineal tearing (≥grade 2 tear) in primiparous women compared to routine manual perineal support. STUDY DESIGN: A single center randomized controlled trial was performed in Sweden 2019-2021. Primiparous women at term were randomly allocated to the intervention group (n=43) where a perineal protection device was used, or to receive routine care (n=49). Main outcome measurement was grade of perineal tear. Secondary outcomes were vaginal and labial tearing. Continuous data was analyzed with Student's T-test or Mann-Whitney U-test. Dichotomous data were analyzed with Pearson X2 test, Fisher's Exact test, and ordinal logistic regression. RESULTS: Women in the intervention group had a significantly lower risk of sustaining more extensive perineal tearing as compared to the control group. Use of the perineal protection device decreased risk of ≥grade 2 tears, in relation to grade 0-1 tears (OR 0.40 [95% CI 0.17-0.94]). Ordinal logistic regression analyses revealed an OR of 0.36 (0.16-0.81) for one-grade-injury increment, using the perineal protection device vs control group (p=0.013). Number needed to treat using the perineal protection device was 4.3 to avoid one ≥grade 2 tear. Women in the treatment group had less labial tearing (p=0.016). No adverse effects were detected. CONCLUSIONS: Use of the perineal protection device reduced the risk of perineal tearing ≥grade 2 tear by 60% as well as labial tearing.

Manual Placenta Removal is Associated with Increased Postpartum Prescriptions of Antibiotics: a Retrospective Cohort Study of Data from the Anti-Infection Tool.

Purpose: No consensus exists whether to administer prophylactic antibiotics in conjunction with manual placenta removal. This study aimed to investigate the postpartum risk of a new prescription of antibiotic treatment, a possible indirect variable for infection, after manual placenta removal. Methods: Obstetric data were merged with data from the Anti-Infection Tool (Swedish antibiotic registry). All vaginal deliveries (n = 13 877) at Helsingborg Hospital, Helsingborg, Sweden, from January 1st, 2014 until June 13th, 2019 were included. Diagnosis codes for infection can be lacking, while the Anti-Infection Tool is complete as it is unavoidable in the computerized prescription system. Logistic regression analyses were performed. The risk of a prescription of antibiotics 24 h to 7 days postpartum was analyzed in the entire study population, and in a subgroup of women not having received any antibiotics 48 h prior to delivery until 24 h after delivery, referred to as "antibiotic-naïve." Results: Manual placenta removal was associated with an increased risk of an antibiotic prescription, adjusted (a) OR = 2.9 (95%CI 1.9-4.3). In the antibiotic-naïve subgroup, manual placenta removal was associated with an increased risk of antibiotic prescription, in general, aOR = 2.2 (95%CI 1.2-4.0), endometritis-specific antibiotics, aOR = 2.7 (95%CI 1.5-4.9), and intravenous antibiotics, aOR = 4.0 (95%CI 2.0-7.9). Conclusion: Manual placenta removal is associated with an increased risk of antibiotic treatment postpartum. An antibiotic-naïve population might benefit from prophylactic antibiotics to reduce the risk of infection, and prospective studies are needed.

Preeclampsia and high blood pressure in early pregnancy as risk factors of severe maternal cardiovascular disease during 50-years of follow-up.

OBJECTIVES: Studies suggest preeclampsia as a risk factor for long term cardiovascular diseases (CVD), while evidence is limited regarding the risk of high blood pressures (BP) in early pregnancy. STUDY DESIGN: A register-based follow-up of 2434 mothers in the Helsingborg Birth Cohort. Associations of high BP in early pregnancy (>95th percentile systolic [SBP], diastolic [BDP], or mean arterial BP [MAP]) during the first antenatal visit and/or preeclampsia with an incident CVD event (ischemic heart disease or stroke) were assessed. To model risks and adjust for co-variables, Cox proportional hazard regression was used. RESULTS: Of the included women, 120 (4.9%) had high SBP, 49 (2%) high DBP, 104 (4.3%) high MAP in early pregnancy; and 115 (4.7%) developed preeclampsia. During 52 years of follow-up, totalling 121,457 person-years, 534 (21.9%) women experienced a CVD event. Women with preeclampsia had a higher risk of developing CVD compared to women without preeclampsia (HR 1.5, 95%CI: 1.1-2.2), while risks among women with high BPs were slightly higher. In adjusted analysis, risk estimates were approximately 50% higher than that of the reference groups for all four studied exposures. Of women with later CVD, 35 (6.6%) had preeclampsia, and another 31 (5,8%) women high SBP or high MAP. Without later preeclampsia, high SBP constituted a significant risk factor (HR 1.6, 95%CI: 1.1-2.4) for CVD. CONCLUSIONS: Women with SBP > 95th percentile in early pregnancy, but without later preeclampsia, have a higher risk of developing CVD that is comparable to women with history of preeclampsia.

Correlations of obstetric anal sphincter injury (OASIS) grade, specific symptoms of anal incontinence, and measurements by endoanal and transperineal ultrasound.

PURPOSE: The aim of the study was to investigate the association between the initial grade of obstetrical anal sphincter injury (OASIS), and Wexner score parameters, with ultrasonographic findings by endoanal ultrasound (EAUS, golden standard) and transperineal ultrasound (TPUS) 6 months post-partum. METHODS: Fifty-nine women after primary repair of OASIS were included at Helsingborg Hospital, Sweden, 2016-2017. Six months post-partum the women filled in a questionnaire regarding symptoms of anal incontinence by the Wexner score and were scanned with EAUS and TPUS (resting state and contracting state) for classification of the residual defect by a modified Starck score. RESULTS: Correlations were found between the OASIS grade and residual defects; length (rs = 0.41, P = 0.003), depth (rs = 0.38, P = 0.006) and angle (rs = 0.40, P = 0.004) of the external anal sphincter (EAS) measured with TPUS in resting state. Using EAUS, correlation between OASIS grade and EAS depth (rs = 0.35, P = 0.007) and angle (rs = 0.37, P = 0.004) were similar, but there was no correlation with length (rs = 0.20, P = 0.14). Between incontinence to gas and the angle of the residual defect in the IAS using TPUS in resting state, correlation was moderate (rs = 0.42, P = 0.003). Regarding incontinence to liquid stool, measurements by TPUS in resting state of EAS residual defect depth (rs = 0.46, P < 0.001) and angle (rs = 0.44, P = 0.001) also correlated moderately. Both corresponding correlations using EAUS were weaker. CONCLUSION: Defects measured with EAUS and TPUS six months post-partum correlated to initial OASIS grade and symptoms of anal incontinence. Specific symptoms correlated with specific anatomical defects, and TPUS was not an inferior method to EAUS.

Early life exposures and risk of adult respiratory disease during 50 years of follow-up.

Adult health is influenced by factors during fetal life affecting organ development and birth weight. We aimed to study such factors in relation to adult respiratory disease (ARD) risk. The Helsingborg Birth Cohort, Sweden, contributed baseline data collected by medical staff through clinical examination and questionnaires on maternal and birth characteristics 1964-1967. Register linkages were performed with completions of data on ARD by ICD 8-10 classifications (1969-2016), and/or ARD-related drug usage (2005-2016) enabling a 50-year follow-up time. Cox proportional hazard regression analyses were made to adjust for potential confounders, adjusted hazard ratio (aHR). A total of 3675 mothers and their offspring were included. Female offspring showed higher frequency of ARD than males, aHR 1.5 (95% CI 1.3-1.8). Maternal use of sedatives during second trimester, aHR 2.2 (95% CI 1.4-3.4), and maternal smoking during most of pregnancy, aHR 1.2 (95% CI 1.0-1.4), were associated with offspring ARD. Stratified by sex, large-for-gestational-age, aHR 1.4 (95% CI 1.0-1.9), was significantly associated with ARD in female offspring along with maternal sedative use during second trimester and maternal smoking during most of pregnancy. Maternal sedative use during second trimester or all trimesters were the only significant risk factors for male offspring. In conclusion, maternal sedative use in second trimester was independently associated with subsequent respiratory disease in adult offspring irrespective of sex.

Comparison of transperineal and endoanal ultrasound in detecting residual obstetric anal sphincter injury.

INTRODUCTION: Endoanal ultrasound is considered the gold standard when assessing the obstetric anal sphincter complex. Due to its relative intrusiveness and economic cost, other ultrasound modalities are on the rise, such as transperineal ultrasound with a convex probe. The aim of our study was to evaluate the agreement between endoanal ultrasound scores (EAUS score) and transperineal ultrasound scores (TPUS score) in assessing residual obstetric anal sphincter defects. MATERIAL AND METHODS: Fifty-nine women were examined 6 months after primary suturing of obstetric anal sphincter injury with two ultrasound modalities. A standardized scoring system analyzing the length, depth and radial extent of both the external (EAS) and internal (IAS) sphincter was used. Wexner fecal incontinence score was used to assess the patients' symptoms. RESULTS: Transperineal ultrasound scores score showed a strong significant correlation with EAUS score during both pelvic floor relaxation and contraction: Spearman's rho [rs ] = 0.74, P < 0.001, and rs  = 0.77, P < 0.001, respectively. For both EAS and IAS, significant correlations were found for all parameters, that is, length, depth and angle between both EAUS and TPUS. A statistically significant correlation was found between EAUS score and Wexner score (rs  = 0.36, P = 0.005). A significant correlation between the EAS-EAUS score (rs  = 0.36, P = 0.005) and Wexner score was found, but no significance was found between IAS-EAUS score and Wexner score (rs  = 0.22, P = 0.097). Significant correlations were found for Wexner score and TPUS score in resting state (rs  = 0.36, P = 0.01) and contracting state (rs  = 0.28, P < 0.05), and between Wexner score and EAS-TPUS score in resting state (rs  = 0.32, P = 0.02). CONCLUSIONS: The results indicated a strong agreement between endoanal and transperineal ultrasound in assessing residual obstetric anal sphincter defects 6 months after primary suturing. Furthermore, a weak significant correlation was found between the ultrasound scores and the patients' Wexner fecal incontinence score.

Glucose homeostasis, beta cell function, and insulin resistance in relation to vitamin D status after gestational diabetes mellitus.

INTRODUCTION: We wanted to determine vitamin D status after gestational diabetes mellitus (GDM) and to evaluate whether levels of 25-hydroxyvitamin D3 (25OHD3 ) are associated with beta cell function, insulin resistance or a diagnosis of diabetes after GDM. MATERIAL AND METHODS: Glucose homeostasis was assessed during a 75-g oral glucose tolerance test one to two years after delivery in 376 women with previous GDM (287 European and 78 non-European, including 33 Arab and 35 Asian women). Insulin resistance was estimated using homeostasis model assessment of insulin resistance (HOMA-IR). The insulinogenic index (I/G30) and the disposition index [(I/G30)/HOMA-IR] were used to calculate insulin secretion. Concentrations of serum 25OHD3 were determined. RESULTS: Mean (±SD) 25OHD3 concentration was 50.0 ± 22.3 nmol/L and differed significantly among subgroups of body mass index, ethnicity, and glucose tolerance status; 53% had 25OHD3 levels <50 nmol/L and 87% had 25OHD3 levels <75 nmol/L. There was a negative correlation between 25OHD3 concentration and HOMA-IR (p < 0.001) and a positive correlation between 25OHD3 and disposition index (p = 0.002) in univariable regression analysis. Correlations attenuated after adjustment for body mass index. In univariable regression analysis, 25OHD3 concentrations were significantly associated with diabetes after GDM (p = 0.004). However, in a multivariable model, non-European origin, HOMA-IR and insulinogenic index were significantly associated with postpartum diabetes, whereas 25OHD3 concentrations were not. CONCLUSION: Vitamin D deficiency/insufficiency in previous GDM cases appears to be associated with beta cell dysfunction and insulin resistance, but not with postpartum diabetes when factors well known to influence type-2 diabetes were adjusted for.

HbA1c as a predictor of diabetes after gestational diabetes mellitus.

AIM: We wanted to investigate third-trimester HbA1c as a predictor of diabetes after gestational diabetes mellitus (GDM). METHODS: Women with GDM were followed up prospectively for five years from pregnancy to detect the development of diabetes. The ability of HbA1c to predict diabetes was evaluated with receiver-operating characteristic (ROC) curves and logistic regression analysis. RESULTS: By five years, 73 of 196 women had been diagnosed with diabetes. An optimal cut-off point for HbA1c of 36mmol/mol (5.4%) could predict diabetes with 45% sensitivity and 92% specificity. For HbA1c ≥39mmol/mol (≥5.7%), sensitivity, specificity, and positive predictive value were 30%, 97%, and 91%, respectively. In logistic regression analysis, adjusting for the diagnostic glucose concentration during pregnancy, HbA1c levels in the upper quartile (≥36mmol/mol) were associated with a 5.5-fold increased risk of diabetes. CONCLUSION: Third-trimester HbA1c levels in the pre-diabetes range revealed women with post-partum diabetes with high specificity and high positive predictive value. HbA1c testing could be used as a strategy to select high-risk women for lifestyle interventions aimed at prevention of diabetes starting during pregnancy. The results should encourage further validation in other populations using new diagnostic criteria for GDM.

Model for individual prediction of diabetes up to 5 years after gestational diabetes mellitus.

AIMS: To identify predictors of diabetes development up to 5 years after gestational diabetes mellitus (GDM) and to develop a prediction model for individual use. METHODS: Five years after GDM, a 75-g oral glucose tolerance test (OGTT) was performed in 362 women, excluding women already diagnosed with diabetes at 1- to 2-year follow-up or later (n = 45). All but 21 women had results from follow-up at 1-2 years, while 84 women were lost from that point. Predictive variables were identified by logistic regression analysis. RESULTS: Five years after GDM, 28/362 women (8 %) were diagnosed with diabetes whereas 187/362 (52 %) had normal glucose tolerance (NGT). Of the latter, 139/187 (74 %) also had NGT at 1- to 2-year follow-up. In simple regression analysis, using NGT at 1-2 years and at 5 years as the reference, diabetes at 1- to 2-year follow-up or later was clearly associated with easily assessable clinical variables, such as BMI at 1- to 2-year follow-up, 2-h OGTT glucose concentration during pregnancy, and non-European origin (P < 0.0001). A prediction model based on these variables resulting in 86 % correct classifications, with an area under the receiver-operating characteristic curve of 0.91 (95 % CI 0.86-0.95), was applied in a function-sheet line diagram illustrating the individual effect of weight on diabetes risk. CONCLUSIONS: The results highlight the importance of BMI as a potentially modifiable risk factor for diabetes after GDM. Our proposed prediction model performed well, and should encourage validation in other populations in future studies.

Seasonal Pattern in the Diagnosis of Gestational Diabetes Mellitus in Southern Sweden.

Aim. The aim of this study was to examine seasonal patterns in glucose tolerance and in the diagnosis of gestational diabetes mellitus (GDM). Methods. Altogether, 11 538 women underwent a 75-g oral glucose tolerance test (OGTT) in the twenty-eighth week of pregnancy during the years 2003-2005 in southern Sweden. GDM was defined by the 2-h capillary glucose concentration in the OGTT (≥8.9 mmol/L). Chi-squared test, analysis of variance, and regression analyses were used for statistical evaluations. Results. The seasonal frequency of GDM ranged from 3.3% in spring to 5.5% in summer (p < 0.0001). Mean 2-h glucose concentrations followed the same seasonal trend, with a difference of 0.15 mmol/L between winter and summer (p < 0.0001). The 2-h glucose level increased by 0.009 mmol/L for every degree increase in temperature (p < 0.0001). In regression analysis, summer (June-August) was associated with increased 2-h glucose level (p < 0.001) and increased frequency of GDM compared to the other seasons (odds ratio 1.51, 95% confidence interval 1.24-1.83, and p < 0.001). Conclusions. Our findings suggest seasonal variation in the 2-h glucose concentration in the OGTT and in the proportion of women diagnosed with GDM, with a peak in the summer.

The relative importance of maternal body mass index and glucose levels for prediction of large-for-gestational-age births.

BACKGROUND: The risk of gestational diabetes mellitus (GDM) increases substantially with increasing maternal body mass index (BMI). The aim of the present study was to evaluate the relative importance of maternal BMI and glucose levels in prediction of large-for-gestational-age (LGA) births. METHOD: This observational cohort study was based on women giving birth in southern Sweden during the years 2003-2005. Information on 10,974 pregnancies was retrieved from a population-based perinatal register. A 75-g oral glucose tolerance test (OGTT) was performed in the 28 week of pregnancy for determination of the 2-h plasma glucose concentration. BMI was obtained during the first trimester. The dataset was divided into a development set and a validation set. Using the development set, multiple logistic regression analysis was used to identify maternal characteristics associated with LGA. The prediction of LGA was assessed by receiver-operating characteristic (ROC) curves, with LGA defined as birth weight > +2 standard deviations of the mean. RESULTS: In the final multivariable model including BMI, 2-h glucose level and maternal demographics, the factor most strongly associated with LGA was BMI (odds ratio 1.1, 95% confidence interval [CI] 1.08-1.30). Based on the total dataset, the area under the ROC curve (AUC) of 2-h glucose level to predict LGA was 0.54 (95% CI 0.48-0.60), indicating poor performance. Using the validation database, the AUC for the final multiple model was 0.69 (95% CI 0.66-0.72), which was identical to the AUC retrieved from a model not including 2-h glucose (0.69, 95% CI 0.66-0.72), and larger than from a model including 2-h glucose but not BMI (0.63, 95% CI 0.60-0.67). CONCLUSIONS: Both the 2-h glucose level of the OGTT and maternal BMI had a significant effect on the risk of LGA births, but the relative contribution was higher for BMI. The findings highlight the importance of concentrating on healthy body weight in pregnant women and closer monitoring of weight during pregnancy as a strategy for reducing the risk of excessive fetal growth.

Role of HbA1c in post-partum screening of women with gestational diabetes mellitus.

AIM: To compare the performance of HbA1c with established glucose criteria during an oral glucose tolerance test (OGTT) and to assess HbA1c as a screening test for undiagnosed diabetes and pre-diabetes after gestational diabetes mellitus (GDM). METHODS: Glucose homeostasis was re-evaluated 1-5 years after delivery in 140 women with previous GDM, by means of OGTT and simultaneous HbA1c measurement. Glucose tolerance was defined according to World Health Organisation criteria. HbA1c ≥6.5% (≥48 mmol/mol) was used for diabetes diagnosis and HbA1c ≥5.7% (≥39 mmol/mol) to define abnormal glucose homeostasis. RESULTS: HbA1c had low sensitivity (14.3%) and high specificity (99.1%) in diabetes diagnosis. Sensitivity and specificity of HbA1c to detect abnormal glucose tolerance were 29.5% and 95.2%, respectively. The consistency in classifying abnormal glucose tolerance between HbA1c and OGTT criteria was 59% (κ = 0.227) and the area under the receiver operating characteristic curve was 0.708. The combined use of HbA1c and fasting glucose criteria showed similar performance to that of fasting glucose criteria alone. The latter identified 63% of the women with pre-diabetes or diabetes in the study cohort. However, by lowering the cut-point of HbA1c to ≥5.0% (≥31 mmol/mol), an additional proportion (27%) with isolated post-glucose load hyperglycaemia was identified. CONCLUSION: Proposed thresholds of HbA1c had low diagnostic sensitivity. Combined with a fasting glucose test, the performance was no better than with using a fasting glucose test alone. Combining a fasting glucose test with a lower HbA1c cut-point may be an alternative approach for selection of women for an OGTT.

Trends in the prevalence of gestational diabetes mellitus in southern Sweden, 2003-2012.

There is accumulating evidence that gestational diabetes is a growing problem. The lack of internationally standardized diagnostic procedures prevents consistent diagnosis and the burden of gestational diabetes must be determined in country-specific studies. In southern Sweden, gestational diabetes is defined as a 2-h capillary plasma glucose concentration of ≥10.0 mmol/L during a universal 75-g oral glucose tolerance test. We report the crude prevalence of gestational diabetes during the years 2003-2012. Of 156 144 women who gave birth, 2.2% were diagnosed with gestational diabetes. When the effect of time on the prevalence of gestational diabetes was assessed in a log-linear Poisson model, an overall increase in prevalence of 35% was predicted, corresponding to an average annual increase of 3.4%. Predicted prevalence was 1.9 (95% CI 1.8-2.0) in 2003 and 2.6 (95% CI 2.4-2.7) in 2012 (p < 0.0001). Due to a simultaneous rise in birth rate, the number of women diagnosed with gestational diabetes increased by 64%.

The impact of ethnicity on glucose homeostasis after gestational diabetes mellitus.

The objective of this study was to examine measures of insulin resistance and beta cell function in relation to ethnicity and the development of diabetes after gestational diabetes mellitus (GDM). Glucose homeostasis was assessed during a 75 g oral glucose tolerance test 1-2 years after delivery in 456 women with previous GDM (362 European, 94 non-European; including 41 Arab and 43 Asian women) and 133 control women. Insulin resistance was estimated using homeostasis model assessment of insulin resistance (HOMA-IR). The insulinogenic index (I/G30) and the disposition index [(I/G30)/HOMA-IR] were used to quantify insulin secretion. Women developing diabetes after GDM were characterized by increased HOMA-IR [p = 0.010, adjusted for body mass index (BMI)], whereas the disposition index was decreased in all women with previous GDM irrespective of glucose tolerance, most pronounced in the presence of diabetes (BMI-adjusted p = 1 × 10(-5)). Non-European origin was associated with increased HOMA-IR (p = 0.001 vs. European), strengthened by adjustment for BMI in Asian women (p = 0.046 vs. p = 0.016), but eradicated among Arab women (p = 0.004 vs. p = 0.65). Non-European women exhibited an increased frequency of diabetes after GDM (17 % vs. European 4 %, p = 2 × 10(-5)). In addition to BMI, non-European and Asian origin was associated with the development of diabetes after GDM in a multivariate logistic regression analysis, whereas Arab origin was not. Our results highlight the importance of preventive measures to ensure a healthy lifestyle in women with GDM, particularly in high-risk ethnic groups.

Evaluation of the relationship between capillary and venous plasma glucose concentrations obtained by the HemoCue Glucose 201+ system during an oral glucose tolerance test.

In 55 women with previous gestational diabetes mellitus, simultaneous capillary and venous plasma glucose concentrations were measured at 0, 30 and 120 min during a 75 g oral glucose tolerance test (OGTT). The aims of the study were to examine the relationship between capillary and venous glucose measurements, and to establish equations for the conversion of capillary and venous glucose concentrations using the HemoCue Glucose 201+ system. Additionally, the correlation between the capillary and venous glucose concentrations with the diagnostic cut-off limits proposed by the World Health Organization (WHO) in 1999 was evaluated. Capillary glucose concentrations were consistently higher than venous glucose concentrations at all time points of the OGTT (p < 0.001), and the correlations between the measurements were statistically highly significant (p < 0.001). The differences between the samples were greatest in the non-fasting state as revealed by the 95% prediction intervals (mmol/L) in Bland-Altman plots; ± 0.54 at 0 min, ± 2.01 at 30 min, and ± 1.35 at 120 min. Equivalence values for capillary plasma glucose concentrations derived from this study tended to be higher than those proposed by the WHO as diagnostic cut-off limits. Stratifying subjects by glucose tolerance status according to the WHO criteria revealed disagreements related to glucose values close to the diagnostic cut-off points. The study findings highlight the uncertainty associated with derived equivalence values. However, capillary plasma glucose measurements could be suitable for diagnostic purposes in epidemiological studies and when translating results on a group basis.