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Background The World Health Organisation (WHO) 2013 diagnostic criteria for gestational diabetes mellitus (GDM) has been criticised due to the limited evidence of benefits on pregnancy outcomes in different populations when switching from previously higher glycemic thresholds to the lower WHO-2013 diagnostic criteria. The aim of this study was to determine whether the switch from previous Swedish (SWE-GDM) to the WHO-2013 GDM criteria in Sweden following risk factor-based screening improves pregnancy outcomes. Methods and findings A stepped wedge cluster randomised trial was performed between January 1 and December 31, 2018 in 11 clusters (17 delivery units) across Sweden, including all pregnancies under care and excluding preexisting diabetes, gastric bypass surgery, or multifetal pregnancies from the analysis. After implementation of uniform clinical and laboratory guidelines, a number of clusters were randomised to intervention (switch to WHO-2013 GDM criteria) each month from February to November 2018. The primary outcome was large for gestational age (LGA, defined as birth weight >90th percentile). Other secondary and prespecified outcomes included maternal and neonatal birth complications. Primary analysis was by modified intention to treat (mITT), excluding 3 clusters that were randomised before study start but were unable to implement the intervention. Prespecified subgroup analysis was undertaken among those discordant for the definition of GDM. Multilevel mixed regression models were used to compare outcome LGA between WHO-2013 and SWE-GDM groups adjusted for clusters, time periods, and potential confounders. Multiple imputation was used for missing potential confounding variables. In the mITT analysis, 47 080 pregnancies were included with 6 882 (14.6%) oral glucose tolerance tests (OGTTs) performed. The GDM prevalence increased from 595/22 797 (2.6%) to 1 591/24 283 (6.6%) after the intervention. In the mITT population, the switch was associated with no change in primary outcome LGA (2 790/24 209 (11.5%) versus 2 584/22 707 (11.4%)) producing an adjusted risk ratio (aRR) of 0.97 (95% confidence interval 0.91 to 1.02, p = 0.26). In the subgroup, the prevalence of LGA was 273/956 (28.8%) before and 278/1 239 (22.5%) after the switch, aRR 0.87 (95% CI 0.75 to 1.01, p = 0.076). No serious events were reported. Potential limitations of this trial are mainly due to the trial design, including failure to adhere to guidelines within and between the clusters and influences of unidentified temporal variations. Conclusions In this study, implementing the WHO-2013 criteria in Sweden with risk factor-based screening did not significantly reduce LGA prevalence defined as birth weight >90th percentile, in the total population, or in the subgroup discordant for the definition of GDM. Future studies are needed to evaluate the effects of treating different glucose thresholds during pregnancy in different populations, with different screening strategies and clinical management guidelines, to optimise women's and children's health in the short and long term. Trial registration The trial is registered with ISRCTN (41918550)., Author(s): Maryam de Brun 1, Anders Magnuson 2, Scott Montgomery 2,3,4, Snehal Patil 2, David Simmons 5,6, Kerstin Berntorp 7, Stefan Jansson 8, Ulla-Britt Wennerholm 9, Anna-Karin Wikström 10, Helen [...]

Background: Metformin is a hypoglycaemic medication that has been proposed to treat or prevent preeclampsia. Combining national birth data from Scotland and Sweden, we investigated whether metformin used during pregnancy was associated with an altered risk of developing a hypertensive disorder of pregnancy. Methods: We utilised data from two population-based cohorts: Scotland (2012–2018) and Sweden (2007–2019). Nulliparous women with gestational diabetes or type 2 diabetes who had birth outcome data linked with medications prescribed during pregnancy were included. The association between metformin prescription and hypertensive disorders of pregnancy was characterised using inverse probability weighted regression analysis, adjusting for variables that predict metformin use and potential confounders. Adverse neonatal outcomes were included as secondary outcomes. Results from both countries were then combined in a meta-analysis using a random effects model. Results: The Scottish cohort included 3859 women with gestational diabetes or type 2 diabetes. Of these women, 30.8% (n = 1187) received at least one metformin prescription during pregnancy. For Sweden, 7771 women with gestational diabetes were included where 19.3% (1498) used metformin during pregnancy. Metformin prescription was not associated with an altered risk of any hypertensive disorder of pregnancy (Scotland adjusted relative risk (aRR) 0.88 [95% confidence interval (CI) 0.66–1.19]; Sweden aRR 1.08 [95% CI 0.86–1.37]) or preeclampsia (Scotland aRR 1.02 [95% CI 0.66–1.60]; Sweden aRR 1.00 [95% CI 0.72–1.39]). Combining adjusted results in a meta-analysis produced similar findings, with a pooled RR of 0.98 (95% CI 0.79–1.18) for any hypertensive disorder and RR 1.01 ([95% CI 0.73–1.28]) for preeclampsia. For neonatal outcomes, metformin was associated with a reduced risk of birthweight > 4500 g in Scotland (aRR 0.39 [95% CI 0.21–0.71]) but not in Sweden. There was no association between metformin and preterm birth or birthweight < 3rd or < 10th percentiles. Pooling results from both countries, metformin was not associated with adverse neonatal outcomes, including preterm birth (RR 1.00 [95% CI 0.89–1.13]), and birthweight < 10th percentile (RR 0.82 [95% CI 0.60–1.13]) or < 3rd percentile (RR 0.78 [95% CI 0.41–1.48]). Conclusions: In this two-country analysis, metformin use in pregnancy among women with diabetes was not associated with an altered risk of developing any hypertensive disorder of pregnancy. In the combined meta-analysis, metformin was not associated with an altered risk of adverse neonatal outcomes. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether perineal wound complications in the first birth, alone or in conjunction with obstetric anal sphincter injury (OASI), is associated with an increased risk of OASI in the second birth. Design: Nationwide population‐based cohort study. Setting: Sweden. Population: Women (n = 411 317) with first and second singleton vaginal births in Sweden, 2001–2019. Methods: Data on diagnostic codes and surgical procedures were retrieved from the Swedish Medical Birth Register and the Swedish Patient Register. A perineal wound complication was defined as wound infection, dehiscence or perineal haematoma within 2 months of childbirth. Main outcome measures: Associations between wound complications in the first birth and OASI in the second birth were investigated with logistic regression and presented as adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs). Results: In total, 2619 (0.6%) women had a wound complication in the first birth, and 5318 (1.3%) had an OASI in the second birth. Women with a wound complication but no OASI in the first birth had more than doubled odds of OASI in the second birth (aOR 2.73, 95% CI 2.11–3.53). Women with OASI and a wound complication in the first birth had almost tenfold odds (aOR 9.97, 95% CI 6.53–15.24) of recurrent OASI. Conclusions: Perineal wound complication in the first birth increases the likelihood of OASI in a subsequent birth. [ABSTRACT FROM AUTHOR]

BACKGROUND Preeclampsia in a first pregnancy is a strong risk factor for preeclampsia in a second pregnancy. Whether chronic hypertension developed after a first pregnancy (interpregnancy hypertension) affects the recurrence risk of preeclampsia is unknown. METHODS This is a population-based cohort study of 391,645 women with their first and second singleton births between 2006 and 2017. Exposure groups were women with preeclampsia in their first pregnancy, interpregnancy hypertension, or both risk factors. Women with neither risk factor were used as a reference group. We calculated the adjusted relative risk (aRR) with 95% confidence intervals (CIs) for overall preeclampsia in the second pregnancy as well as preterm (<37 gestational weeks) and term (≥37 gestational weeks) subgroups of the disease. RESULTS Women with preeclampsia in their first pregnancy who did or did not develop interpregnancy hypertension had rates of preeclampsia in their second pregnancy of 21.5% and 13.6%, respectively. In the same population, the corresponding rates of preterm preeclampsia were 5.5% and 2.6%, respectively. After adjusting for maternal factors, women with preeclampsia in their first pregnancy who developed interpregnancy hypertension and those who did not have almost the same risk of overall preeclampsia in their second pregnancy (aRRs with 95% CIs: 14.51; 11.77–17.89 and 12.83; 12.09–13.62, respectively). However, preeclampsia in the first pregnancy and interpregnancy hypertension had a synergistic interaction on the outcome of preterm preeclampsia (aRR with 95% CI 26.66; 17.44–40.80). CONCLUSIONS Women with previous preeclampsia who developed interpregnancy hypertension had a very high rate of preterm preeclampsia in a second pregnancy, and the two risk factors had a synergistic interaction. [ABSTRACT FROM AUTHOR]

Objective: To explore whether the association between polycystic ovary syndrome (PCOS) and pre‐eclampsia depends on treated clinical hyperandrogenism and whether PCOS is associated with different subtypes of pre‐eclampsia. Design: Nationwide register‐based cohort study. Setting: Sweden. Population: Nulliparous women with PCOS (n = 22 947) and non‐PCOS controls (n = 115 272) giving singleton birth at ≥22 gestational weeks during 1997–2015. Treated clinical hyperandrogenism was defined as filled prescriptions of anti‐androgenic drugs during 2005–2017 (n = 2301 among PCOS women). Methods: The risk of pre‐eclampsia was estimated with conditional logistic regression, expressed as adjusted odds ratio (OR) with 95% confidence interval (CI). Adjustments were performed individually for confounders and predictors. Main outcome measures: Overall pre‐eclampsia. Early/late (delivery <34/≥34 weeks) pre‐eclampsia. Pre‐eclampsia with or without a small‐for‐gestational‐age (SGA) infant. Results: Compared with controls, women with PCOS had a 29% increased risk of pre‐eclampsia (predictor adjusted OR 1.29, 95% CI 1.20–1.39), with similar risk estimates for PCOS women with and without treated clinical hyperandrogenism. The association between PCOS and early pre‐eclampsia seemed stronger than its association with late pre‐eclampsia (predictor adjusted OR 1.64 (95% CI 1.33–2.02) and 1.26 (95% CI 1.17–1.37). Additionally, the association seemed slightly stronger between PCOS and pre‐eclampsia in women with an SGA infant than without. Conclusions: Women with PCOS face an increased risk for pre‐eclampsia, especially early pre‐eclampsia and pre‐eclampsia with an SGA infant. We were unable to determine on the basis of available data, whether hyperandrogenism is associated with pre‐eclampsia. [ABSTRACT FROM AUTHOR]

Background: Severe perineal lacerations (SPLs), common worldwide, are associated with short- and long-term complications: pelvic floor disorders, fecal incontinence, fistula, and profound psychological impacts. Limited research suggests that experiencing SPL may influence future reproductive intentions, but research on outcomes is lacking. Methods: We analyzed the effect of experiencing SPL during a first delivery among a large cohort of Swedish births between 1992 and 2013. We used linear and multinomial logistic regression to estimate the associations between SPL and four reproductive outcomes: subsequent total birth number, probability of a second birth, interpregnancy interval (IPI), and subsequent scheduled cesarean birth. Results: Among 947,035 singleton live-born first-births, we found that experiencing SPL was associated with slightly fewer overall births in fully adjusted models (a decrease of −0.020 births; 95% confidence interval [CI]: −0.028 to −0.012), but no difference in the probability of a second birth (risk ratio [RR]: 1.00; 95% CI: 0.99 to 1.00) or IPI. Scheduled cesarean was increased in births after SPL (adjusted RR: 4.57; 95% CI: 4.42 to 4.73). A secondary comparison of SPL to severe postpartum hemorrhage suggests that some of these observed differences may be related to experiencing any severe outcome, and some specifically to perineum disruption. Conclusion: This study provides a deeper understanding of the long-term impacts of SPL, which may be useful in informing best clinical practices for supporting women who have experienced SPL. [ABSTRACT FROM AUTHOR]

Background: The number of pregnant women with congenital heart disease (CHD) is rising, and the disease poses increased risks of cardiovascular and obstetric complications during pregnancy, potentially impacting breastfeeding success. This study aimed to investigate breastfeeding in primiparous women with CHD compared to primiparous women without CHD, and to examine potential hindering factors for breastfeeding in women with CHD. Methods: The data were gathered between 2014 and 2019 and obtained by merging the Swedish Congenital Heart Disease Register (SWEDCON) with the Swedish Pregnancy Register. Primiparous women ≥ 18 years of age with CHD (n = 578) were matched by age and municipality to 3049 women without CHD, giving birth after 22 gestational weeks. Multivariable logistic regression analysis was used to identify factors associated with non-breastfeeding in women with CHD. Results: Fewer women with CHD breastfed than women without CHD two days (94% vs. 97%, p = 0.001) and four weeks after birth (84% vs. 89%, p = 0.006). When all women were analysed, having CHD was associated with non-breastfeeding at both two days and four weeks after birth. For women with CHD, body mass index (BMI) ≥ 30 (OR 3.1; 95% CI 1.4, 7.3), preterm birth (OR 6.4; 95% CI 2.1, 19.0), self-reported history of psychiatric illness (OR 2.4; 95% CI 1.2, 5.1), small for gestational age (OR 4.2; 95% CI 1.4, 12.2), and New York Heart Association Stages of Heart Failure class II − III (OR 6.0; 95% CI 1.4, 26.7) were associated with non-breastfeeding two days after birth. Four weeks after birth, factors associated with non-breastfeeding were BMI ≥ 30 (OR 4.3; 95% CI 2.1, 9.0), self-reported history of psychiatric illness (OR 2.2; 95% CI 1.2, 4.2), and preterm birth (OR 8.9; 95% CI 2.8, 27.9). Conclusions: The study shows that most women with CHD breastfeed, however, at a slightly lower proportion compared to women without CHD. In addition, factors related to the heart disease were not associated with non-breastfeeding four weeks after birth. Since preterm birth, BMI ≥ 30, and psychiatric illness are associated with non-breastfeeding, healthcare professionals should provide greater support to women with CHD having these conditions. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether mild neonatal hypoxic ischaemic encephalopathy (HIE) in term born infants is associated with cerebral palsy, epilepsy, mental retardation and death up to 6 years of age. Design: Population‐based cohort study. Setting: Sweden, 2009–2015. Population: Live term born infants without congenital malformations or chromosomal abnormalities (n = 505 075). Methods: Birth and health data were retrieved from Swedish national health and quality registers. Mild HIE was identified by diagnosis in either the Swedish Medical Birth Register or the Swedish Neonatal Quality Register. Cox proportional hazards regression was used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Main outcome measures: A composite of the outcomes cerebral palsy, epilepsy, mental retardation and death up to 6 years of age. Results: Median follow‐up time was 3.3 years after birth. Of 414 infants diagnosed with mild HIE, 17 were classified according to the composite outcome and incidence rates were 12.6 and 2.9 per 1000 child‐years in infants with and without HIE respectively. Infants with mild HIE was four times as likely to be diagnosed with the composite outcome (HR 4.42, 95% CI 2.75–7.12) compared with infants without HIE. When analysed separately, associations were found with cerebral palsy (HR 21.50, 95% CI 9.59–48.19) and death (HR 19.10, 95% CI 7.90–46.21). HRs remained essentially unchanged after adjustment for covariates. Conclusions: Mild neonatal HIE was associated with neurological morbidity and mortality in childhood. Challenges include identifying infants who may develop morbidity and how to prevent adverse outcomes. Linked article: This article is commented on by William M. Curtin, pp. 1610 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471-0528.17596. [ABSTRACT FROM AUTHOR]