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Induction of labor is increasing worldwide, and some countries have started to introduce outpatient induction in low-risk women.To assess current knowledge concerning the safety, efficacy, women´s experience and economic costs of outpatient induction compared with inpatient induction.Multiple databases were last searched on October 19PICO; P-women with low-risk pregnancy planned for induction of labor. I-Outpatient induction C-Inpatient induction O-Outcomes according to the core outcome set for induction of labor (COSIOL).Pooled in meta-analyses. The certainty of evidence was assessed using the GRADE system.The included 20 studies, including 7,956 women, showed an overall low incidence of adverse events and indicated comparable results for inpatient and outpatient induction, but the studies were underpowered for safety related outcomes. Women's experiences from outpatient induction were mostly positive. Based on three studies, the economic costs consequence is inconclusive.Due to early randomization, heterogenic study design and underpowered studies regarding safety outcome the certainty of evidence is very low. It is uncertain whether outpatient induction affects the risk for neonatal and maternal complications.

Background The COVID-19 pandemic has had a profound effect on the emotional well-being of expecting mothers. Sweden’s unique strategy for managing COVID-19 involved no national lockdown. Emphasis was instead placed on limiting crowding and asking citizens to practice social distancing measures. Aim To gain a deeper understanding of how women not infected by SARS-CoV-2 experienced pregnancy during the COVID-19 pandemic in Sweden. Methods This was a qualitative study with a reflective lifeworld approach. Fourteen women that had not contracted COVID-19 and who were pregnant during the first and second wave of the pandemic were interviewed. Data were analysed with a phenomenological reflective lifeworld approach. Findings The essence of the women’s experiences of being pregnant during the COVID-19 pandemic was best described as being in the shadow of the unknown, where the COVID-19 pandemic could at times totally overshadow the experience of being pregnant, while at other times, rays of sunlight pierced through the clouds. The experience was characterised by having to deal with the uncertainties caused by the pandemic and feelings of being in an information echo. Women felt socially isolated and had to face maternal check-ups without the support of their partners. There was, however, a strong trust in maternal health-care services despite the lack of information available. Conclusion Being in the shadow of the unknown represents the uncertainties posed by the COVID-19 pandemic on the experience of pregnancy. Sufficient information, a companion of choice and screening for emotional well-being are important factors in maternity care during pandemics.

Objective To assess associations of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection and pregnancy outcomes considering testing policy and test‐positivity‐to‐delivery interval. Design Nationwide cohort study. Setting Sweden. Population From the Pregnancy‐Register we identified 88 593 singleton births, 11 March 2020–31 January 2021, linked to data on SARS‐CoV‐2‐positivity from the Public Health Agency, and information on neonatal care admission from the Neonatal Quality Register. Adjusted odds ratios (aORs) were estimated stratified by testing‐policy and test‐positivity‐to‐delivery interval. Main outcome measures Five‐minute Apgar score, neonatal care admission, stillbirth and preterm birth. Results During pregnancy, SARS‐CoV‐2 test‐positivity was 5.4% (794/14 665) under universal testing and 1.9% (1402/73 928) under non‐universal testing. There were generally lower risks associated with SARS‐CoV‐2 under universal than non‐universal testing. In women testing positive >10 days from delivery, generally no significant differences in risk were observed under either testing policy. Neonatal care admission was more common (15.3% versus 8.0%; aOR 2.24, 95% CI 1.62–3.11) in women testing positive ≤10 days before delivery under universal testing. There was no significant association with 5‐minute Apgar score below 7 (1.0% versus 1.7%; aOR 0.64, 95% CI 0.24–1.72) or stillbirth (0.3% versus 0.4%; aOR 0.72, 95% CI 0.10–5.20). Compared with term births (2.1%), test‐positivity was higher in medically indicated preterm birth (5.7%; aOR 2.70, 95% CI 1.60–4.58) but not significantly increased in spontaneous preterm birth (2.3%; aOR 1.12, 95% CI 0.62–2.02). Conclusions Testing policy and timing of test‐positivity impact associations between SARS‐CoV‐2‐positivity and pregnancy outcomes. Under non‐universal testing, women with complications near delivery are more likely to be tested than women without complications, thereby inflating any association with adverse pregnancy outcomes compared with findings under universal testing. Tweetable abstract Testing policy and time from SARS‐CoV‐2 infection to delivery influence the association with pregnancy outcomes., Tweetable abstract Testing policy and time from SARS‐CoV‐2 infection to delivery influence the association with pregnancy outcomes.

Objective To assess the cost-effectiveness of induction of labour (IOL) at 41 weeks of gestation compared with expectant management until 42 weeks of gestation. Design A cost-effectiveness analysis alongside the Swedish Post-term Induction Study (SWEPIS), a multicentre, randomised controlled superiority trial. Setting Fourteen Swedish hospitals during 2016-2018. Population Women with an uncomplicated singleton pregnancy with a fetus in cephalic position were randomised at 41 weeks of gestation to IOL or to expectant management and induction at 42 weeks of gestation. Methods Health benefits were measured in life years and quality-adjusted life years (QALYs) for mother and child. Total cost per birth was calculated, including healthcare costs from randomisation to discharge after delivery, for mother and child. Incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in mean cost between the trial arms by the difference in life years and QALYs, respectively. Sampling uncertainty was evaluated using non-parametric bootstrapping. Main outcome measures The cost per gained life year and per gained QALY. Results The differences in life years and QALYs gained were driven by the difference in perinatal mortality alone. The absolute risk reduction in mortality was 0.004 (from 6/1373 to 0/1373). Based on Swedish life tables, this gives a mean gain in discounted life years and QALYs of 0.14 and 0.12 per birth, respectively. The mean cost per birth was euro4108 in the IOL group (n = 1373) and euro4037 in the expectant management group (n = 1373), with a mean difference of euro71 (95% CI -euro232 to euro379). The ICER for IOL compared with expectant management was euro545 per life year gained and euro623 per QALY gained. Confidence intervals were relatively wide and included the possibility that IOL had both lower costs and better health outcomes. Conclusions Induction of labour at 41 weeks of gestation results in a better health outcome and no significant difference in costs. IOL is cost-effective compared with expectant management until 42 weeks of gestation using standard threshold values for acceptable cost per life year/QALY. Tweetable abstract Induction of labour at 41 weeks of gestation is cost-effective compared with expectant management until 42 weeks of gestation.

Abstract Background Triage, identifying patients with critical and time-sensitive disorders, is an integrated process in general emergency medicine. Obstetric triage is more specialised, requiring assessment of both woman, fetus and labour status. Failure to identify severely ill obstetric patients has repeatedly led to maternal morbidity and mortality. Reliable triage systems, adapted to obstetric patients as well as local conditions, are thus essential. The study aims to assess the interrater reliability (IRR) of the Gothenburg Obstetric Triage System (GOTS). Methods Midwives (n = 6) and registered nurses with no experience in managing obstetric patients (n = 7), assessed 30 paper cases based on actual real-life cases, using the GOTS. Furthermore, a reference group consisting of two midwives and two obstetricians, with extensive experience in obstetric care, determined the correct triage level in order to enable analysis of over- and undertriage. IRR was assessed, both with percentage of absolute agreement and with intra-class correlation coefficients (ICC) with 95% confidence intervals (CI). Results A total of 388 assessments were performed, comprising all five levels of acuity in the GOTS. Absolute agreement was found in 69.6% of the assessments. The overall IRR was good, with a Kappa value of 0.78 (0.69–0.87, 95% CI) for final triage level. Comparison with reference group assessments established that over- and undertriage had occurred in 9% and 21% of the cases, respectively. The main reasons for undertriage were “not acknowledging abnormal vital sign parameters” and “limitations in study design”. Conclusion The GOTS is a reliable tool for triaging obstetric patients. It enables a standardized triage process unrelated to the assessors’ level of experience in assessing and managing obstetric patients and is applicable for triaging obstetric patients presenting for emergency care at obstetric or emergency units.

Excisional treatment of cervical intraepithelial neoplasia or very early stages of cervical cancer increases the risk of preterm prelabor rupture of membranes (PPROM) in subsequent pregnancies. The risk increases with the length of the excised cone. The subset of PPROM with a history of cervical excisional treatment could also be jeopardized by a higher risk intra-amniotic infection/inflammation . However, there is a paucity of relevant information on this field.To assess the differences in the rates of intra-amniotic infection/inflammation and early-onset neonatal sepsis between singleton PPROM pregnancies without and with a history of cervical excisional treatment and to identify an association between these complications of PPROM and the excised cone length.This retrospective cohort study included 770 PPROM pregnancies in whom transabdominal amniocentesis was performed as part of standard clinical management to determine intra-amniotic environment. The maternal and perinatal medical records of all included women were reviewed to obtain information on the absence or presence of a history of cervical excisional treatment and neonatal outcomes. Women whose records contained any information on a history of cervical excisional treatment were contacted by phone and in writing to inform them of the study and request permission to collect relevant information from their medical records. Women were divided into four subgroups according to the presence of microorganisms and/or their nucleic acids (through culturing and molecular biology method) in amniotic fluid and/or intra-amniotic inflammation (through amniotic fluid interleukin-6 concentration evaluation): intra-amniotic infection (presence of both), sterile intra-amniotic inflammation (intra-amniotic inflammation alone), microbial invasion of the amniotic cavity without inflammation (the presence of microorganisms and/or their nucleic acids in amniotic fluid alone), and negative amniotic fluid for infection/inflammation (absence of both).A history of cervical excisional treatment was found in 10% (76/765) of the women. Of these, 82% (62/76) had a history of only one treatment, and information on the cone length was available for 97% (60/62) of them. Women with a history of cervical excisional treatment had higher rates of intra-amniotic infection [with: 25% (19/76) vs. without: 12% (85/689), adj. OR: 2.5, adj. p = 0.004], microbial invasion of the amniotic cavity without inflammation [with: 25% (19/76) vs. without: 11% (74/689), adj. OR: 3.1, adj. p0.0001], and early-onset neonatal sepsis [with: 8% (11/76) vs. without: 3% (23/689), adj. OR: 2.9, adj. p = 0.02] than those without cervical excisional treatment. Quartiles of the cone length (range: 3-32 mm) were used to categorize the women into four quartile subgroups (1History of cervical excisional treatment increases risks of intra-amniotic infection, microbial invasion of the amniotic cavity without inflammation, and development of early-onset neonatal sepsis in a subsequent pregnancy complicated by preterm prelabor rupture of membranes.

Introduction Induction of labor is increasing. A common indication for induction of labor is late term and postterm pregnancy at 41 weeks or more. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0 to 1 weeks of gestation. Material and methods In this observational study, based on data from the Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1213 women with a low-risk singleton pregnancy at 41 to 42 weeks of gestation were induced with oral misoprostol (n = 744) or transvaginal balloon catheter (n = 469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24 h and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time to vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analog scale. We present crude and adjusted mean differences and relative risks (RR) with 95% CI. Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score. Results Vaginal delivery within 24 h was significantly lower in the misoprostol group compared with the balloon catheter group (46.5% [346/744] versus 62.7% [294/469]; adjusted RR 0.76 95% CI 0.640.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31-1.89]; maternal composite 2.3% [17/744] versus 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58-4.97]). Adjusted mean time to vaginal delivery was increased by 3.8 h (95% CI 1.3-6.2 h) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups. Conclusion Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24 h and a longer time to vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery, and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.

Introduction: Continuous glucose monitoring (CGM) provides detailed information about glucose level fluctuations over time. The method is increasingly being used in pregnant women with type 1 diabetes. However, only one previous study compared CGM results related to pregnancy outcomes in women using insulin pumps with those administering multiple daily injections (MDI). We performed a secondary analysis of CGM metrics from an observational cohort of pregnant women with type 1 diabetes and compared insulin pump and MDI therapies in relation to maternal and neonatal outcomes. Material and methods: The study included 185 pregnant Swedish women with type 1 diabetes undergoing CGM throughout pregnancy. Women were divided according to insulin administration mode, ie MDI (n = 131) or pump (n = 54). A total of 91 women used real-time CGM and 94 women used intermittently viewed CGM. Maternal demographics and maternal and neonatal outcome data were collected from medical records. CGM data were analyzed according to predefined glycemic indices: mean glucose; standard deviation; percentage of time within, below and above glucose target range; mean amplitude of glycemic excursion; high and low glucose indices; and coefficient variation in percent. Associations between insulin administration mode and CGM data, on the one hand, and maternal and neonatal outcomes, on the other, were analyzed with analysis of covariance and logistic regression, respectively, adjusted for confounders. Results: There were no differences in maternal characteristics or glycemic indices between the MDI and pump groups, except for a longer duration of type 1 diabetes and higher frequencies of microangiopathy and real-time CGM among pump users. Despite improvement with each trimester, glucose levels remained suboptimal throughout pregnancy in both groups. There were no differences between the MDI and pump groups concerning the respective associations with any of the outcomes. The frequency of large for gestational age was high in both groups (MDI 49% vs pump 63%) and did not differ significantly. Conclusions: Pregnant women with type 1 diabetes did not differ in glycemic control or pregnancy outcome, related to MDI or pump administration of insulin. Glycemic control remained suboptimal throughout pregnancy, regardless of insulin administration mode. (Less)

Background: The screening strategy in Sweden for GDM is mainly based on random plasma glucose measurements combined with presence of risk factors (previous GDM or LGA (large for gestational age) /macrosomia, obesity, heredity, accelerated growth or polyhydramnios) . The association of risk factors with mean levels of glucose in the diagnostic OGTT in different populations is unclear. Method/Material: Data from Changing Diagnostic Criteria for GDM in Sweden (CDC4G) - a stepped wedge randomised RCT (ISRCTN41918550) where centers during 2018 were randomized to switch to new IADPSG criteria for GDM every month. All pregnant women underwent a venous OGTT during 2018. Mean glucose values by risk factor are presented with 95% CI, significant p value Results: Of 53 124 pregnancies 69 (13.0%) underwent venous OGTT. Either metformin or Insulin was used in 11% before the diagnostic criteria switch and 18.8% after the switch. Metformin only was used in 9.7% before and in 16.4% after randomization to new criteria. Conclusions: BMI≥35 or Previous LGA/macrosomia were associated with a higher fasting glucose value in OGTT, but previous GDM, accelerated growth and high random blood glucose were statistically significantly associated with higher glucose values in all measurements in the diagnostic OGTT. Women with previous GDM had the highest proportion treated with either insulin and/or metformin Disclosure H.E.Fadl: None. H.Strevens: None. U.Wennerholm: None. M.Persson: None. M.De brun: None. S.Montgomery: None. D.Simmons: Other Relationship; Elsevier, Research Support; Abbott, Hitachi, Ltd., Novo Nordisk, Speaker's Bureau; Sanofi. S.Patil: None. A.Wikström: None. S.P.Jansson: None. V.Sengpiel: None. K.Berntorp: None. L.Ryen: None. F.Ahlsson: None. E.S.Lindholm: None. Funding Swedish Research Council (2018-00470)

Purpose Current knowledge of the effect of prenatal caffeine exposure on the child’s neurodevelopment is contradictory. The current study aimed to study whether caffeine intake during pregnancy was associated with impaired child neurodevelopment up to 8 years of age. Method A total of 64,189 full term pregnancies from the Norwegian Mother, Father and Child Cohort Study were included. A validated food-frequency questionnaire administered at gestational week 22 was used to obtain information on maternal caffeine intake from different sources. To assess child neurodevelopment (behaviour, temperament, motor development, language difficulties) validated scales were used to identify difficulties within each domain at 6, 18, 36 months as well as 5 and 8 years of age. Adjusted logistic regression models and mixed linear models were used to evaluate neurodevelopmental problems associated with maternal caffeine intake. Results Prenatal caffeine exposure was not associated with a persistently increased risk for behaviour, temperament, motor or language problems in children born at full-term. Results were consistent throughout all follow-ups and for different sources of caffeine intake. There was a minor trend towards an association between consumption of caffeinated soft drinks and high activity level, but this association was not driven by caffeine. Conclusion Low to moderate caffeine consumption during pregnancy was not associated with any persistent adverse effects concerning the child’s neurodevelopment up to 8 years of age. However, a few previous studies indicate an association between high caffeine consumption and negative neurodevelopment outcomes.

The aim of this study was to investigate how the changed work routines during the COVID-19 pandemic has been affecting the working environment for hospital-based maternity and neonatal health care workers, and to identify preventive measures to be used in future situations when health care organizations are under pressure.All maternity and neonatal health care workers in a Swedish university hospital were surveyed during October 2019 and September 2020. The data was analyzed by document analysis of implemented changes in working routines, a quantitative analysis of the overall effects on the working conditions, and a qualitative analysis of open-ended responses.A total of 660 maternity and neonatal health care workers completed the pre-COVID-19 survey (74% response rate) and 382 the COVID-19 survey (35% response rate). Lack of personal protective equipment, worry about becoming infected, uncertainty whether implemented changes were enough, and challenges in communicating updated routines had negative effects on maternity and neonatal health care workers' working conditions. Team spirit and feeling valued by peers had a positive effect.Results suggest that negative effects on maternity and neonatal health care workers' health can partly be prevented in future critical situations by creating a work climate that acknowledges the employees' worry about being infected, securing adequate pre-conditions for managers, creating a strong psychosocial safety climate and systematically improving the working conditions for the maternity and neonatal health care workers, as well as maintaining the positive perceived effects of increased team spirit and feeling valued by peers.

Background and Problem Existing healthcare systems have been put under immense pressure during the COVID-19 pandemic. Disruptions in essential maternal and newborn services have come from even high-income countries within the World Health Organization (WHO) European Region. Aim To describe the quality of care during pregnancy and childbirth, as reported by the women themselves, during the COVID-19 pandemic in Sweden, using the WHO ‘Standards for improving quality of maternal and newborn care in health facilities’. Methods Using an anonymous, online questionnaire, women ≥18 years were invited to participate if they had given birth in Sweden from March 1, 2020 to June 30, 2021. The quality of maternal and newborn care was measured using 40 questions across four domains: provision of care, experience of care, availability of human/physical resources, and organisational changes due to COVID-19. Findings Of the 5003 women included, n = 4528 experienced labour. Of these, 46.7% perceived a poorer quality of maternal and newborn care due to the COVID-19. Fundal pressure was applied in 22.2% of instrumental vaginal births, 36.8% received inadequate breastfeeding support and 6.9% reported some form of abuse. Findings were worse in women undergoing prelabour Caesarean section (CS) (n = 475). Multivariate analysis showed significant associations of the quality of maternal and newborn care to year of birth (P < 0.001), parity (P < 0.001), no pharmacological pain relief (P < 0.001), prelabour CS (P < 0.001), emergency CS (P < 0.001) and overall satisfaction (P < 0.001). Conclusion Considerable gaps over many key quality measures and deviations from women-centred care were noted. Findings were worse in women with prelabour CS. Actions to promote high-quality, evidence-based and respectful care during childbirth for all mothers are urgently needed.

Background Postpartum septic symphysitis (PPSS) is defined as acute onset of severe pain around the symphysis, restricted movement, fever, and elevated inflammatory parameters. It is a rare but serious condition requiring urgent diagnosis and treatment. The aim of this study was to describe the incidence, symptoms, diagnosis, treatment, and long-term follow-up of PPSS. Methods This follow-up study included 19 out of 21 women diagnosed with PPSS from 1989 to 2017 at one tertiary care hospital in Sweden. Clinical data were retrieved from hospital records and compared to those retrieved from a regional registry. Women completed a postal questionnaire, and those who reported lumbopelvic pain (LPP) were offered a clinical examination. Results 1) PPSS was diagnosed after a normal postpartum period of 24 to 50 h by blood tests (n = 19/19), ultrasonography (n = 9 /19), computer tomography (n = 8/19) or magnetic resonance imaging (n = 16/19) Treatment included aspiration of symphyseal abscesses, i.v. antibiotics and different physiotherapeutic interventions. Women with PPSS more frequently were primiparous (n = 14/19, p = 0.001), had an instrumental delivery (n = 14/19, p = 0.003), longer time of active labour (p = 0.01) and second stage of labour (p = 0.001) than women in the regional registry. 2) Ten out of 19 (52%) women reported LPP at follow-up. These women more often suffered impaired function related to LPP (Pelvic Girdle Questionnaire, 27 versus 0, p p = 0.001 and EuroQol-visual analogue scale, 65 mm versus 84 mm, p = 0.022) and higher levels of anxiety and depression (Hospital Anxiety Depression Scale (HADS) HADS-Anxiety, 7 versus 2, p = 0.010; and HADS-Depression, 1 versus 0, p = 0.028) than women with no pain. 3). Of the eight women who were clinically assessed, one had lumbar pain and seven had pelvic girdle pain (PGP). Conclusions In the largest cohort of patients with PPSS to date, primiparas and women with instrumental vaginal delivery were overrepresented, indicating that first and complicated deliveries might be risk factors. Approximately half of the women reported PGP at follow-up, with considerable consequences affecting health-related quality of life and function decades after delivery. Prospective multicentre studies are needed to establish risk factors, long-term consequences, and adequate treatment for this rare pregnancy complication.

Background Failure to identify severely ill obstetric patients seeking acute care, and hence delaying treatment, can lead to maternal morbidity and mortality. Triage is the prioritization of patients seeking emergency care, based on clinical decision-making tools assessing medical urgency. While triage has been applied in general emergency medicine for 30 years, there are only a few obstetric triage systems (OTS) and obstetric triage has hitherto been unknown in Sweden. Obstetric triage is more complex than general triage since both mother and fetus require assessment, and pregnancy-related physiological changes must be taken into account. This paper aims to describe the development and an initial evaluation of the first OTS in Sweden. Methods A multidisciplinary team surveyed reasons to seek acute obstetric care and the current patient flow at the largest obstetric unit in Scandinavia, Sahlgrenska University Hospital, Gothenburg, Sweden, with about 10,000 deliveries/year. A semi-structured literature review on obstetric triage was undertaken. Based on the survey and the literature review the first Swedish OTS was developed and implemented. Patient satisfaction was followed by electronical questionnaires. Initial validity evaluation was performed, defined by the system’s ability to identify patients with need for hospital admission, stratified by acuity level. Results The Gothenburg Obstetrical Triage System (GOTS) addresses the patient to one of five acuity levels based on both vital signs and 14 chief complaint algorithms. It entails recommendations for initial procedures of care as well as an acuity form for documentation. Initial evaluation of the system indicates good correlation between need for admission and acuity level. The implementation has provided the staff with an improved medical overview of the patients and patient flow and enabled the unit to monitor emergency care in a structured way. Implementation came along with increased patient and staff satisfaction. Conclusion The GOTS is the first OTS developed in and for Sweden and implementation has improved management of obstetric patients seeking acute care. Patients are now prioritized according to level of acuity and the time to assessment and treatment of severely ill patients can be structurally evaluated. Both patients and staff express improved satisfaction with obstetric triage.

IntroductionPre-eclampsia, a multisystem disorder in pregnancy, is one of the most common causes of maternal morbidity and mortality worldwide. However, we lack methods for objective assessment of organ function in pre-eclampsia and predictors of organ impairment during and after pre-eclampsia. The women’s and their partners’ experiences of pre-eclampsia have not been studied in detail. To phenotype different subtypes of the disorder is of importance for prediction, prevention, surveillance, treatment and follow-up of pre-eclampsia.The aim of this study is to set up a multicentre database and biobank for pre-eclampsia in order to contribute to a safer and more individualised treatment and care.Methods and analysisThis is a multicentre cohort study. Prospectively recruited pregnant women ≥18 years, diagnosed with pre-eclampsia presenting at Sahlgrenska University Hospital, Uppsala University Hospital and at Södra Älvsborgs Hospital, Sweden, as well as normotensive controls are eligible for participation. At inclusion and at 1-year follow-up, the participants donate biosamples that are stored in a biobank and they are also asked to participate in various organ-specific evaluations. In addition, questionnaires and interviews regarding the women’s and partner’s experiences are distributed at follow-up.Ethics and disseminationBy creating a database and biobank, we will provide the means to explore the disorder in a broader sense and allow clinical and laboratory discoveries that can be translated to clinical trials aiming at improved care of women with pre-eclampsia. Further, to evaluate experiences and the psychological impact of being affected by pre-eclampsia can improve the care of pregnant women and their partners. In case of incidental pathological findings during examinations performed, they will be handled in accordance with clinical routine. Data are stored in a secure online database. Biobank samples are identified through the women’s personal identification number and pseudonymised after identification in the biobank before analysis.This study was approved by the regional ethical review board in Gothenburg on 28 December 2018 (approval number 955-18) and by the Swedish Ethical Review Authority on 27 February 2019 (approval number 2019-00309).Results from the study will be published in international peer-reviewed journals.Trial registration numberISRCTN13060768

Background Excisional treatment of cervical intraepithelial neoplasia (CIN) has been associated with increased risk of preterm delivery (PTD), although the underlying mechanism is as yet unclear. Studies on formalin-fixed excised tissue indicate that the risk increases with cone-length, but the magnitude of increase is uncertain, especially in case of minor excisions (≤10 mm), as well compared to women with untreated CIN during pregnancy. This study assesses the impact of cone-length at previous treatment for CIN as well as diagnosis of CIN during pregnancy on the risk of PTD. Methods A register-based cohort study in western Sweden linking cervical cytology, histology, and treatment data from the Swedish National Cervical Screening Registry to data on obstetric outcomes in singleton pregnancies 2008–2016 from the Swedish Medical Birth Registry. These groups were compared for PTD and other obstetric outcomes: (1) women with one excisional treatment (n=3250, including a subgroup (n=2408) with cone-length measured before fixation; (2) women with untreated CIN diagnosed during pregnancy (n=1380); and (3) women with normal cytology (n=42,398). Logistic regression analyses were adjusted for socioeconomic and health-related confounders. Results Treated women had increased risk of PTD (adjusted odds ratio (aOR) 1.60, 95% confidence interval (CI) 1.21–2.12), spontaneous PTD (aOR 1.95, 95% CI 1.40–2.72) and preterm prelabor rupture of membranes (pPROM) (aOR 2.74, 95% CI 1.66–4.51) compared to the CIN during pregnancy group. ORs were similar when compared to the normal cytology group. Risks of these outcomes increased with cone-length. Mean cone-length was 9.1 mm. Cone-length ≤10 mm was associated with increased risk of PTD (aOR 1.41, 95% CI 1.02–1.94), spontaneous PTD (aOR 1.73, 95% CI 1.18–2.54), and pPROM (aOR 2.44, 95% CI 1.40–4.28), compared to the CIN during pregnancy group. The PTD risk was similar for cone-lengths 3–10 mm, thereafter increasing by 15% with each additional millimeter. Conclusions This study suggests that all excisional treatment, including small cones, are associated with increased risk of PTD and pPROM. Risks increase further with cone-length. In women of reproductive age, clinicians should aim to remove all CIN but minimal healthy cervical tissue. Cone-length should be recorded at treatment, for future prenatal risk estimation.

The first positive genome-wide association study on gestational length and preterm delivery showed the involvement of an Se metabolism gene. In the present study, we examine the association between maternal intake of Se and Se status with gestational length and preterm delivery in 72 025 women with singleton live births from the population-based, prospective Norwegian Mother, Father and Child Cohort Study (MoBa). A self-reported, semi-quantitative FFQ answered in pregnancy week 22 was used to estimate Se intake during the first half of pregnancy. Associations were analysed with adjusted linear and Cox regressions. Se status was assessed in whole blood collected in gestational week 17 (n 2637). Median dietary Se intake was 53 (interquartile range (IQR) 44–62) µg/d, supplements provided additionally 50 (IQR 30–75) µg/d for supplement users (n 23 409). Maternal dietary Se intake was significantly associated with prolonged gestational length (β per sd = 0·25, 95 % CI, 0·07, 0·43) and decreased risk of preterm delivery (n 3618, hazard ratio per sd = 0·92, 95 % CI, 0·87, 0·98). Neither Se intake from supplements nor maternal blood Se status was associated with gestational length or preterm delivery. Hence, the present study showed that maternal dietary Se intake but not intake of Se-containing supplements, during the first half of pregnancy was significantly associated with decreased risk of preterm delivery. Further investigations, preferably in the form of a large randomised controlled trial, are needed to elucidate the impact of Se on pregnancy duration.

Background The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden (www.cdc4g.se/en) is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches. Methods This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January–December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included. Discussion The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child. Trial registration CDC4G is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017)

INTRODUCTION Increasing evidence suggests that cervical intraepithelial neoplasia, with or without subsequent treatment, is associated with preterm delivery. We aimed to explore the association between abnormal cervical cytology of different severity and the subsequent obstetric outcomes such as preterm delivery. MATERIAL AND METHODS The historical register-based cohort study comprised 19 822 women in the Western Region of Sweden who had at least one abnormal cervical cytology from 1978 to 2012 before the age of 45 and a subsequent singleton delivery. The reference group comprised 39 644 women with normal cervical cytology and a subsequent singleton delivery, matched by age and parity. Data were retrieved from the Swedish National Cervical Screening Registry, linked to the Swedish Medical Birth Register and Statistic Sweden. The study outcomes were spontaneous preterm delivery before 37 and 34 weeks, low birthweight (≤2500 g), small-for-gestational-age, preterm premature rupture of membranes and neonatal mortality. Multivariable log binominal regression analyses were applied. RESULTS Preterm delivery before 37 weeks was more common among women with abnormal cervical cytology compared with reference group: 6% vs 4.5%; adjusted relative risk 1.30 (95% confidence interval 1.21-1.39). High vs low-grade abnormal cervical cytology implied a higher risk: 7% vs 5.8% (P

Background Maternal caffeine intake has repeatedly been linked to babies being born small for gestational age (SGA). SGA babies are known to be at increased risk for adverse neonatal outcomes. The aim of this study was to explore the associations between prenatal caffeine exposure and neonatal health. Methods The study is based on 67,569 full-term singleton mother-infant pairs from the Norwegian Mother and Child Cohort Study. Caffeine consumption from different sources was self-reported in gestational week 22. Neonatal compound outcomes, namely (1) morbidity/mortality and (2) neonatal intervention, were created based on the Medical Birth Registry of Norway. Adjusted logistic regression was performed. Results Caffeine exposure was associated to SGA (OR = 1.16, 95%CI: 1.10; 1.23) and being born SGA was significantly associated with neonatal health (OR = 3.09, 95%CI: 2.54; 3.78 for morbidity/mortality; OR = 3.94, 95%CI: 3.50; 4.45 for intervention). However, prenatal caffeine exposure was neither associated with neonatal morbidity/mortality (OR = 1.01, 95%CI: 0.96; 1.07) nor neonatal intervention (OR = 1.02, 95%CI: 1.00; 1.05 for a 100 mg caffeine intake increase). Results did not change after additional adjustment for SGA status. Conclusions Moderate prenatal caffeine exposure (

Properly working antioxidant defence systems are important for fetal development. One of the nutrients with antioxidant activity is selenium. Increased maternal selenium intake has been associated with reduced risk for being small for gestational age and preterm delivery. Based on the Norwegian Mother, Father, and Child Cohort Study and the Medical Birth Registry of Norway, we investigated the association of maternal selenium intake from food and dietary supplements during the first half of pregnancy (n = 71,728 women) and selenium status in mid-pregnancy (n = 2628 women) with neonatal health, measured as two composite variables (neonatal morbidity/mortality and neonatal intervention). Low maternal dietary selenium intake (&lt, 30 µg/day) was associated with increased risk for neonatal morbidity/mortality (adjusted odds ratio (adjOR) 1.36, 95% confidence interval (95% CI) 1.08–1.69) and neonatal intervention (adjOR 1.16, 95% CI 1.01–1.34). Using continuous variables, there were no associations between maternal selenium intake (from diet or supplements) or whole-blood selenium concentration and neonatal outcome in the adjusted models. Our findings suggest that sufficient maternal dietary selenium intake is associated with neonatal outcome. Adhering to the dietary recommendations may help ensure an adequate supply of selenium for a healthy pregnancy and optimal fetal development.

ObjectiveTo compare childbirth experiences in women randomly assigned to either induction of labour at 41 weeks or to expectant management until 42 weeks, in the Swedish Post-term Induction Study.DesignA register-based, multicentre, randomised, controlled, superiority trial.SettingWomen were recruited at 14 hospitals in Sweden, 2016–2018.ParticipantsWomen with an uncomplicated singleton pregnancy were recruited at 41 gestational weeks.InterventionsThe women were randomly assigned to induction of labour at 41 weeks (induction group, n=1381) or expectant management until 42 weeks (expectant management group, n=1379).Outcome measuresAs main outcome, women’s childbirth experiences were measured using the Childbirth Experience Questionnaire version 2 (CEQ2), in 656 women, 3 months after the birth at three hospitals. As exploratory outcome, overall childbirth experience was measured in 1457 women using a Visual Analogue Scale (VAS 1–10) within 3 days after delivery at the remaining eleven hospitals.ResultsThe total response rate was 77% (2113/2760). There were no significant differences in childbirth experience measured with CEQ2 between the groups (induction group, n=354; expectant management group, n=302) in the subscales:own capacity(2.8 vs 2.7, p=0.09),perceived safety(3.3 vs 3.2, p=0.06) andprofessional support(3.6 vs 3.5, p=0.38) or in the total CEQ2 score (3.3 vs 3.2, p=0.07), respectively. Women in the induction group scored higher in the subscaleparticipation(3.6 vs 3.4, p=0.02), although with a small effect size (0.19). No significant difference was observed in overall childbirth experience according to VAS (8.0 (n=735) vs 8.1 (n=735), p=0.22).ConclusionsThere were no differences in childbirth experience, according to CEQ2 or overall childbirth experience assessed with VAS, between women randomly assigned to induction of labour at 41 weeks or expectant management until 42 weeks. Overall, women rated their childbirth experiences high.Trial registration numberISRCTN26113652.

Background: Holistic antenatal care requires knowledge of individuals’ emotional response to pregnancy. Little is known about how a pregnant woman and her partner influence each other emotionally during a pregnancy. This study examines six discrete emotions that expectant couples experience during pregnancy, how these emotions change during pregnancy, and whether the partner’s emotional responses influence each other. Methods: A longitudinal dyadic study where pregnant women and their partners (1,432 couples) rated the extent to which the pregnancy evoked joy, strength, security, worry, shame, and anger at pregnancy weeks 12–19, 22–24, and 36. Latent curve models with structured residuals identify levels of and change in these emotions over time, while accounting for between- and within-couple variance. Findings: Pregnancy evoked mainly joy, strength, security and worry, and to the same extent in both groups. Levels of anger and shame were low, but higher for pregnant women than partners. There was little to no mean-level change in all six measured emotions evoked by pregnancy, and no reciprocal effects between the partners. Interpretation: Emotions in early pregnancy are felt also in late pregnancy. Furthermore, the pregnant woman and her partner have individual emotional trajectories. The results can assist healthcare professionals and researchers target interventions to expectant mothers and partners, specifically by understanding emotional response to pregnancy as a stable confound and by not approaching the couple as one emotional unit. Funding Information: This study was funded by The Swedish Research Council (2015-01546), Knut and Alice Wallenberg Foundation (KAW2017.0245), and the University of Gothenburg. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: The Swedish Ethical Review Authority approved the SPP on April 15, 2019 (Dnr: 1061-18).

Background Pregnancy-induced hypertensive disorders (PIHD), including preeclampsia, cause maternal and perinatal morbidity and mortality worldwide. Several studies have linked selenium supplementation and selenium status to the risk of preeclampsia, but there are no published prospective population-based studies examining associations between dietary selenium intake and preeclampsia. Aim To examine associations between selenium intake from diet and supplements and selenium blood status and PIHD incidence, with sub-analyses for pregnancy-induced hypertension (PIH) and preeclampsia, in a large pregnancy cohort. Method The study is based on 69,972 singleton pregnancies from the Norwegian Mother, Father and Child Cohort Study. Maternal dietary selenium intake was assessed with a validated, semi-quantitative food frequency questionnaire at about gestational week 22. Maternal selenium concentrations were measured in whole blood collected around gestational week 18 in a subset of 2572 women. Preeclampsia and PIH diagnosges were obtained from the Medical Birth Registry of Norway. Results Participants had a median dietary selenium intake of 53 μg/day (IQR 44–62). Dietary selenium intake was not significantly associated with PIHD (adjusted (a) OR 1.03, 95% CI 0.98, 1.08 per SD of selenium intake), preeclampsia or PIH. Threshold analyses for deciles of dietary selenium intake did not show any significant associations. Neither inorganic (aOR 1.01, 95% CI 0.98, 1.05) or organic selenium supplement intake (aOR 0.98, 95% CI 0.95, 1.02) or selenium blood status was significantly associated with PIHD (aOR 1.03, 95% CI 0.86, 1.22) or PIHD subgroups. Conclusion No significant associations were found between reported selenium intake from diet, or dietary supplements or whole-blood selenium status and PIHD in general or preeclampsia specifically. Hence, the results of this large population-based study, with selenium intake close to the recommended daily intake, do not support previous findings indicating a possible protective effect of selenium supplementation or selenium status with regard to preeclampsia incidence.