Trends in Term Intrapartum Stillbirth in Norway.

Importance: Fetal death during labor at term is a complication that is rarely studied in high-income countries. There is a need for large population-based studies to examine the rate of term intrapartum stillbirth in high-income countries and the factors associated with its occurrence. Objective: To evaluate trends in term intrapartum stillbirth over time and to investigate the association between the trends and term intrapartum stillbirth risk factors from 1999 to 2018 in Norway. Design, Setting, and Participants: This cohort study used data from the Medical Birth Registry of Norway from 1999 to 2018 to examine rates of term intrapartum stillbirth and risk factors associated with this event. A population of 1 021 268 term singleton pregnancies without congenital anomalies or antepartum stillbirths was included in analyses, which were performed from September 2022 to February 2023. Exposure: The main exposure variable was time, which was divided into four 5-year periods: 1999 to 2003, 2004 to 2008, 2009 to 2013, and 2014 to 2018. Main Outcomes and Measures: The primary study outcome was term intrapartum stillbirth. Risk ratios were calculated, and multivariable logistic regression analyses were conducted to identify factors associated with secular trends of term intrapartum stillbirth. Results: The study population consisted of 1 021 268 term singleton births (maternal mean [SD] age, 29.72 [5.01] years; mean [SD] gestational age, 39.69 [1.27] weeks). During the study period, there were 95 term intrapartum stillbirths (0.09 per 1000 births). Maternal age, the proportion of individuals born in a country other than Norway, and the prevalence of gestational diabetes, labor induction, operative vaginal delivery, and previous cesarean delivery increased over the course of the study period. Conversely, the prevalence of infants large for gestational age, hypertensive disorder in pregnancy, and spontaneous vaginal delivery and the proportion of individuals who smoked decreased. The term intrapartum stillbirth rate decreased by 87% (95% CI, 68%-95%) from 0.15 per 1000 births in 1999 to 2008 to 0.02 per 1000 births in 2014 to 2018. Three in 4 term intrapartum stillbirths (70 of 95) occurred during intrapartum operative deliveries. The increased prevalence of older maternal age and obstetric risk factors were not associated with the variation in intrapartum stillbirth rates among the time periods. The prevalence of term intrapartum stillbirth was higher for individuals who gave birth in maternity units with fewer than 3000 annual births (adjusted odds ratio, 1.67; 95% CI, 1.07-2.61) than for those who gave birth in units with 3000 or more annual births. Conclusions and Relevance: Findings of this study suggest that, despite increases in maternal and obstetric risk factors, term intrapartum stillbirth rates substantially decreased during the study period. Reasons for this decrease may be due to improvements in intrapartum care.

Neonatal outcomes associated with time from a high fetal blood lactate concentration to operative delivery.

INTRODUCTION: Adjunctive technologies to cardiotocography intend to increase the specificity of the diagnosis of fetal hypoxia. If correctly diagnosed, time to delivery could affect neonatal outcome. In the present study, we aimed to investigate the effect of time from when fetal distress is indicated by a high fetal blood sample (FBS) lactate concentration to operative delivery on the risk of adverse neonatal outcomes. MATERIAL AND METHODS: We conducted a prospective observational study. Deliveries with a singleton fetus in cephalic presentation at 36+0 weeks of gestation or later were included. Adverse neonatal outcomes, related to decision-to-delivery interval (DDI), were investigated in operative deliveries indicated by an FBS lactate concentration of at least 4.8 mmol/L. We applied logistic regression to estimate crude and adjusted odds ratios (aOR) of various adverse neonatal outcomes, with associated 95% confidence intervals (CI), for a DDI exceeding 20 minutes, compared with a DDI of 20 minutes or less. CLINICALTRIALS: gov Identifier: NCT04779294. RESULTS: The main analysis included 228 women with an operative delivery indicated by an FBS lactate concentration of 4.8 mmol/L or greater. The risk of all adverse neonatal outcomes was significantly increased for both DDI groups compared with the reference group (deliveries with an FBS lactate below 4.2 mmol/L within 60 minutes before delivery). In operative deliveries indicated by an FBS lactate concentration of 4.8 mmol/L or more, there was a significantly increased risk of a 5-minute Apgar score less than 7 if the DDI exceeded 20 minutes, compared with a DDI of 20 minutes or less (aOR 8.1, 95% CI 1.1-60.9). We found no statistically significant effect on other short-term outcomes for deliveries with DDI longer than 20 minutes, compared with those with DDI of 20 minutes or less (pH ≤7.10: aOR 2.0, 95% CI 0.5-8.4; transfer to the neonatal intensive care unit: aOR 1.1, 95% CI 0.4-3.5). CONCLUSIONS: After a high FBS lactate measurement, the increased risk of adverse neonatal outcome is further augmented if the DDI exceeds 20 minutes. These findings give support to current Norwegian guidelines for intervention in cases of fetal distress.

Intrapartum pudendal nerve block analgesia and childbirth experience in primiparous women with vaginal birth: A cohort study.

BACKGROUND: A negative childbirth experience has short- and long-term consequences for both mother and child. This study aimed to investigate the association between intrapartum pudendal nerve block (PNB) analgesia and childbirth experience. METHODS: Primiparous women with a singleton cephalic vaginal live births at term at Oslo University Hospital from January 1, 2017, to June 1, 2019, were eligible for inclusion. The main outcome was total score on a childbirth experience questionnaire (range 1.0-4.0, higher score indicates better childbirth experience). An absolute risk difference of 0.10 was considered clinically relevant. Propensity score matching was used to adjust for differences in baseline characteristics between women with and without PNB. The analyses were stratified by spontaneous vs instrumental birth. Subanalyses of the questionnaire's domains (own capacity, professional support, perceived safety, and participation) were performed. RESULTS: Of 979 participating women, mean age was 32 years. Childbirth experience did not differ between women with and without PNB, either in spontaneous (absolute risk difference of the mean: -0.05, P value 0.36) or in instrumental birth (absolute risk difference of the mean: 0.03, P value 0.61). There were no statistically significant differences between PNB group scores for the separate domains. CONCLUSIONS: Women's childbirth experiences did not differ between birthing people with or without PNB, either in spontaneous or in instrumental births. The clinical implications of our study should be interpreted in light of the pain-relieving effects of PNB.PNB should be provided on clinical indication, including for individuals with severe labor pain.

Group B Streptococcus colonization at delivery is associated with maternal peripartum infection.

BACKGROUND: Group B Streptococcus (GBS) is a major cause of serious neonatal infection but its role in maternal morbidity has received little investigation. The aim of this study was to determine whether GBS colonization at delivery is associated with increased risk of maternal peripartum infection. METHODS: In this prospective cohort study, 1746 unselected women had a vaginal-rectal culture taken at the onset of labor. Diagnosis of maternal peripartum infection was based on a combination of two or more signs or symptoms including fever, breast pain, severe wound or pelvic pain, purulent discharge and abnormal laboratory tests including C-reactive protein and white blood cell count occurring from labor until 2 weeks postpartum. The main outcome measure was the proportion of women with maternal peripartum infection according to GBS colonization status. RESULTS: A total of 25.9% (452/1746) women were colonized with GBS. The rate of peripartum infection was almost twice as high in colonized women (49/452 [10.8%]) vs. non-colonized women (81/1294 [6.3%]); OR 1.82 [1.26-2.64], p = 0.002). This association was confirmed in a multivariable model (OR 1.99 [1.35-2.95], p = 0.001). Women diagnosed with peripartum infection had a significantly longer hospital stay compared to women without peripartum infection (4 days (median) vs. 3 days, p < 0.001). Length of hospital stay did not differ between colonized and non-colonized women. Serotype IV GBS was more frequent in colonized women with peripartum infection than in women without peripartum infection (29.3% vs. 12.5%, p = 0.003). CONCLUSIONS: GBS colonization at delivery is associated with increased risk of peripartum infection. Whether this increase is due directly to invasion by GBS or whether GBS colonization is associated with a more general vulnerability to infection remains to be determined.

Knowledge of gestational diabetes mellitus at first consultation in a multi-ethnic pregnant population in the Oslo region, Norway - a cross-sectional study.

Objectives: Gestational diabetes mellitus (GDM) is an increasing problem among pregnant women globally and is associated with short- and long-term consequences for both mother and newborn. The aim of this study was to investigate knowledge of GDM among a multi-ethnic pregnant population at first consultation for GDM in the Oslo region in Norway.Design: We conducted a cross-sectional study using baseline data from a randomised controlled study performed at five diabetic outpatient clinics (DOC) in the Oslo region. Pregnant women diagnosed with GDM following an Oral Glucose Tolerance test (OGTT) with a 2-hours blood glucose level of ≥ 9 mmol/l were included. Women filled out a questionnaire on an electronic tablet at the study entry, and additional data were collected through a recruiting form. Descriptive statistics were performed and associations were investigated using Chi-square test and multiple logistic regression analysis.Results: Of 238 women included in the study, 108 (45.4%) were native Norwegian speakers and 130 (54.6%) were non-native Norwegian speakers. 39.5% of the non-native Norwegian speakers were Asian, 22.5% were African, and 15.5% were from Eastern European Countries. Non-native Norwegian speakers were significantly more likely to have poor knowledge of GDM compared to native Norwegian speakers, adjusted OR = 4.5, 95% CI 1.61-12.5. Sensitivity analyses showed this was not due to poor language skills.Conclusions: Ethnic background was associated with the level of knowledge of GDM. Health professionals should be aware of the various knowledge levels concerning GDM and tailor their information towards women's knowledge. Linguistically- and culturally adapted information regarding GDM may improve knowledge gaps among women with immigrant backgrounds.

Prospective assessment of vacuum deliveries from midpelvic station in a tertiary care university hospital: Frequency, failure rates, labor characteristics and maternal and neonatal complications.

BACKGROUND: Midpelvic vacuum extractions are controversial due to reports of increased risk of maternal and perinatal morbidity and high failure rates. Prospective studies of attempted midpelvic vacuum outcomes are scarce. Our main aims were to assess frequency, failure rates, labor characteristics, maternal and neonatal complications of attempted midpelvic vacuum deliveries, and to compare labor characteristics and complications between successful and failed midpelvic vacuum deliveries. STUDY DESIGN: Clinical data were obtained prospectively from all attempted vacuum deliveries (n = 891) over a one-year period with a total of 6903 births (overall cesarean section rate 18.2% (n = 1258). Student's t-test, Mann-Whitney U-test or Chi-square test for group differences were used as appropriate. Odds ratios and 95% confidence intervals are given as indicated. The uni- and multivariable analysis were conducted both as a complete case analysis and with a multiple imputation approach. A p-value of <0.05 was considered statistically significant. RESULTS: Attempted vacuum extractions from midpelvic station constituted 36.7% (n = 319) of all attempted vacuum extractions (12.9% (n = 891) of all births). Of these 319 midpelvic vacuum extractions, 11.3% (n = 36) failed and final delivery mode was cesarean section in 86.1% (n = 31) and forceps in the remaining 13.9% (n = 5). Successful completion of midpelvic vacuum by 3 pulls or fewer was achieved in 67.1%. There were 3.9% third-degree and no fourth-degree perineal tears. Cup detachments were associated with a significantly increased failure rate (adjusted OR 6.13, 95% CI 2.41-15.56, p< 0.001). CONCLUSION: In our study, attempted midpelvic vacuum deliveries had relatively low failure rate, the majority was successfully completed within three pulls and they proved safe to perform as reflected by a low rate of third-degree perineal tears. We provide data for nuanced counseling of women on vacuum extraction as a second stage delivery option in comparable obstetric management settings with relatively high vacuum delivery rates and low cesarean section rates.

Prior Thromboembolic Disease and Assisted Reproductive Therapy.

Assisted reproductive therapy (ART) increases the risk of venous thrombosis (VT) by 2- to 4-fold, whereas pregnancy increases the risk by 5- to 10-fold. Women with a history of VT undergoing ART are often suggested thromboprophylaxis. The literature is scarce and international guidelines are lacking. We made a review of the literature and base our suggestions primarily on expert opinions. We suggest women with a prior VT to use low-molecular-weight heparin as thromboprophylaxis starting from ovarian stimulation, throughout pregnancy, and 6 weeks postpartum. Assessment of VT risk should be done prior to ART. Adjustment of treatment to minimize the thrombotic risk, such as preventing ovarian hyperstimulation syndrome, single-embryo transfer, cryopreservation, and transfer of frozen embryos instead of fresh embryo in high-risk women, is suggested. Women with previous arterial thrombosis should continue aspirin during ART treatment, pregnancy, and postpartum.

Intrapartum pudendal nerve block analgesia and risk of postpartum urinary retention: a cohort study.

INTRODUCTION AND HYPOTHESIS: Pudendal nerve block analgesia (PNB) is used as pain relief in the final stage of childbirth. We hypothesized that PNB is associated with higher rates of postpartum urinary retention. METHODS: We performed a cohort study among primiparous women with a singleton, cephalic vaginal birth at Oslo University Hospital, Norway. Women receiving PNB were included in the exposed group, while the subsequent woman giving birth without PNB was included in the unexposed group. We compared the likelihood of postpartum urinary retention, defined as catheterization within 3 h after birth. Logistic regression analysis stratified by mode of delivery was performed adjusting for epidural analgesia, episiotomy and birth unit. RESULTS: Of the 1007 included women, 499 were exposed to PNB and 508 were unexposed. In adjusted analyses, women exposed to PNB did not differ in likelihood of postpartum urinary retention compared to women unexposed to PNB in either spontaneous (odds ratio[OR]: 0.82, 95% confidence interval [CI] 0.55-1.22) or instrumental (OR 1.45, 95% CI 0.89-2.39) births. Furthermore, no differences between the groups were observed with excessive residual urine volume or catheterization after > 3 h. CONCLUSIONS: PNB was associated with neither risk of postpartum urinary retention nor excessive residual urine volume and is therefore unlikely to hamper future bladder function.

Audit of Early and Late Maternal Deaths in Georgia: Potential for Improving Substandard Obstetric Care.

INTRODUCTION: Quality of care is an important factor in reducing preventable maternal deaths, yet it is a significant challenge in many countries. Substandard and poor quality of care is the leading factor in two-thirds of maternal deaths in European countries. Our study investigated the deaths of all women of reproductive age in 2012 in Georgia. The aim was to define the underlying causes of maternal deaths and to identify the factors in women's care which contributed to the fatal outcomes. METHODS: A national Reproductive Age Mortality Survey was conducted in Georgia in 2014-15. Data from multiple sources was triangulated to identify all deaths of women of reproductive age. This was followed by verbal autopsy diagnoses. Each case of early and late maternal death was investigated through interviews and medical record reviews at the last medical facility providing care for the deceased woman. A specialist panel reviewed and assigned underlying causes of death, assessed the management of each woman's condition, and identified elements of suboptimal care. RESULTS: We identified a total of 23 maternal deaths, including 15 (65%) early and eight (35%) late deaths. The maternal mortality ratio was 26.3 per 100 000 live births. The four leading causes of early maternal deaths were: sepsis, hemorrhage, embolism, and pregnancy-induced hypertension. Embolism and sepsis were the direct causes of the eight late maternal deaths. Cancer, tuberculosis, and postpartum suicide constituted the indirect causes of death. Improvements in care which would have made a difference to the outcomes were identified in 87% of early maternal deaths and 67% of late maternal deaths due to direct obstetric causes. DISCUSSION: Delayed recognition and inappropriate management of maternal complications were common across almost all cases studied. The findings from Georgia highlight the conclusion that most maternal deaths were preventable and that improvement in obstetric care is urgently required.

Structured clinical examinations in labor: rekindling the craft of obstetrics.

OBJECTIVES: Exact knowledge of fetal station and position is of paramount importance for reliable surveillance of labor progress and a prerequisite for safe operative vaginal procedures. Detailed clinical assessments are thoroughly described in old textbooks, but almost forgotten in contemporary obstetrics. Ultrasound is suggested as an objective diagnostic tool in active labor. Several publications have demonstrated a low correlation between ultrasound and clinical assessment of fetal head station and position, but the methods of clinical assessment in these studies are poorly described. We wanted to explore if a quality clinical assessment could perform better than clinical assessment in previous publications, by analyzing the correlation between a structured method of clinical assessment and intrapartum ultrasound. METHODS: In all, 100 laboring women with cervical dilatation ≥7 cm were included in a prospective cohort study at Oslo University Hospital-Ullevål from October to December 2016. The study design was cross-sectional. Clinical examinations were performed by one special educated consultant (JKI), and transabdominal and transperineal ultrasound clips were recorded and examined by a blinded expert in intrapartum ultrasound (TME). Fetal position was classified as a clock face with 12 units (hourly divisions) and thereafter categorized as occiput anterior (OA), left occiput transverse (LOT), occiput posterior (OP), and right occiput transverse (ROT) positions. Fetal station was categorized clinically from -5 to +5 and measured with ultrasound as angle of progression (AoP) and head-perineum distance (HPD). AoP is the angle between a longitudinal line through the symphysis and a tangent to the head contour. HPD is the shortest distance between the fetal skull and the perineum. RESULTS: Eight women were excluded due to strong contractions between clinical assessments and ultrasound measurements, fetal distress, or incomplete examinations. Fetal position assessed with ultrasound and clinical examination agreed exactly in 48/92 (52%) of cases, within one unit (hour) in 87/92 (95%) of cases and within two units in 90/92 (98%) of cases. It differed by three units in one case and by five units in one case. The agreement categorized into OA, LOT, OP, and ROT was good (Cohen's kappa 0.72; 95% CI 0.61-0.84). For station, the agreement was very good for both HPD (Pearson correlation coefficient r = 0.86; 95% CI 0.80-0.91) and AoP (r = 0.77; 95% CI to 0.67-0.84). The correlation between HPD and AoP was good (r = 0.76; 95% CI 0.65-0.84). CONCLUSION: We found very good correlations between structured clinical assessments and ultrasound examinations, suggesting that an objective quality in clinical examinations is possible to achieve. More focus on clinical skills training may improve accuracy for clinicians.

The provision of epidural analgesia during labor according to maternal birthplace: a Norwegian register study.

BACKGROUND: The provision of epidural analgesia during labor is ideally a shared decision between the woman and her health care provider. However, immigrant characteristics such as maternal birthplace could affect decision-making and thus access to pain relief. We aimed to assess disparities in the provision of epidural analgesia in planned vaginal birth according to maternal region of birth. METHODS: We performed a nation-wide register study of 842,496 live-born singleton deliveries in Norway between 2000 and 2015. Maternal birthplace was categorized according to the Global Burden of Disease framework. The provision of epidural analgesia was compared in regression models stratified by parity and mode of delivery. RESULTS: Compared to native-born women, primiparous women from Latin America/Caribbean countries with an instrumental vaginal delivery were most likely to be provided epidural analgesia (OR 2.12, 95%CI 1.69-2.66), whilst multiparous women from Sub-Saharan Africa with a spontaneous vaginal delivery were least likely to be provided epidural analgesia (OR 0.42, 95% C 0.39-0.44). Longer residence time was associated with a higher likelihood of being provided analgesia, whereas effects of maternal education varied by Global Burden of Disease group. CONCLUSIONS: Disparities in the likelihood of being provided epidural analgesia were observed by maternal birthplace. Further studies are needed to consider whether the identified disparities represent women's own preferences or if they are the result of heterogeneous access to analgesia during labor.

Maternal Mortality in Georgia: Incidence, Causes and Level of Underreporting: A National Reproductive Age Mortality Study 2014.

INTRODUCTION: Accurate data on maternal mortality are essential for assessing progress towards Sustainable Development Goals (SDG).The aim of the study was to determine the incidence and causes of maternal deaths in Georgia, then explore the potential for improvement of quality of maternal health care. The study's secondary aims were to identify the level of underreporting of maternal deaths in Georgian vital statistics over 1 year (2012) and to compare these results with previous data from 2006. The study findings allow to support the country in developing evidence-based policies and tracking progress towards meeting SDG targets. METHODS: A national Reproductive Age Mortality Survey (RAMOS) was conducted in Georgia in 2014-15. Multiple data sources were used to identify deaths of women aged 15-49 years between January and December 2012. All deaths in women of reproductive age were investigated through verbal autopsy (VA) diagnoses. Deaths in women during pregnancy or one-year postpartum were further investigated by conducting interviews and medical record reviews at the last medical facility which provided health care for the woman during her fatal condition. A specialist panel reviewed these cases and assigned underlining causes of deaths. RESULTS: We found that 98% of deaths among women of reproductive age were registered by Georgia's civil registration and vital statistics system (CRVS). A total of 918 deaths met the study inclusion criteria. Thirty-six (4.1%) women died during pregnancy or within one-year postpartum. Among these 36 deaths, 23 (63.8%) were maternal deaths, 15 early (either during pregnancy or 42 days postpartum) and eight late (43-365 days postpartum) deaths (65.2% vs 34.8%). The remaining 13 of 36 deaths were coincidental deaths. Fourteen maternal deaths were reported by official statistics and nine deaths were not included in these statistics. Thus, the underreporting rate was 39%. Direct obstetric causes accounted for 73.9% (n=17) of maternal deaths, whereas 26.1% (n=6) were indirect. The leading causes of direct maternal deaths were infection (21.7%), hemorrhage (17.4%), pulmonary embolism (13.0%), and pregnancy-induced hypertension (8.7%). The RAMOS study calculated a maternal mortality ratio (early maternal deaths) of 26.3 per 100,000 live births compared with the official figure of 22.8 per 100,000 live births. DISCUSSIONS: Registration of early maternal deaths significantly improved since last survey in 2008, while indirect and late maternal deaths continue to be unrecognized, as reflected in official Georgian statistics. The difference between RAMOS study findings and officially reported maternal mortality rates is minimal, showing improvements in detection of maternal deaths by the national maternal mortality surveillance system. The greatest number of direct obstetric deaths occur in the first week postpartum, which likely reflects deficiencies in quality of care.

Adverse perinatal outcomes in 665,244 term and post-term deliveries-a Norwegian population-based study.

OBJECTIVE: To assess the prevalence and risk of adverse perinatal outcomes in early-term (37+0-38+6 weeks), full-term (39+0-40+6 weeks), late-term (41+0-41+6 weeks), and post-term (>42+0 weeks) deliveries with spontaneous labor onset. STUDY DESIGN: A population-based cohort with data from the Medical Birth Registry Norway (MBRN) and Statistics Norway (SSB) was conducted. The study population consisted of 665,244 women with cephalic singleton live births at term or post-term with spontaneous labor onset during the period of 1999-2014 in Norway. Maternal, obstetric, and fetal characteristics were obtained from the MBRN. Maternal education data were obtained from the SSB. The prevalence rates of adverse perinatal outcomes for each gestational age (GA) group were estimated. Inter-group differences were detected with Chi square tests. Multivariable regression analysis adjusted for maternal age, educational level, smoking, parity, maternal diabetes, and preeclampsia was used to assess adverse outcome prevalence for early- late-, and post-term births compared to full-term births. RESULTS: Deliveries at early-term were associated with an increased prevalence of neonatal jaundice, polyhydramnios, small for gestational age (SGA) status, respiratory support, and neonatal intensive care unit (NICU) admission compared with deliveries at GAs of 39-43 weeks (p < 0.001). Low 5-min Apgar scores and newborn antibiotic treatment occurred at an increased prevalence in both early-term and post-term infants, relative to the full-term group (p < 0.001). The prevalence of oligohydramnios, meconium-stained amniotic fluid, and newborn birth injuries increased with increasing GA. CONCLUSIONS: More perinatal morbidity was observed among early-term infants compared to infants with later term deliveries, underscoring the need for cautious management of low-risk early-term deliveries.

Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway.

OBJECTIVE: To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet. DESIGN: A multicentre, non-blinded randomised controlled trial. SETTING: Five diabetes outpatient clinics in the Oslo region. PARTICIPANTS: Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum. INTERVENTION: The Pregnant+ app and usual care, the control group received usual care. PRIMARY AND SECONDARY OUTCOMES: The primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported. RESULTS: No difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered. CONCLUSION: The Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant. TRIAL REGISTRATION NUMBER: NCT02588729.

Elevated Complement C3 and C4 Levels are Associated with Postnatal Pregnancy-Related Venous Thrombosis.

High levels of complement C3 are associated with venous thrombosis (VT) in the general population. We investigated if high C3 and C4 levels were associated with pregnancy-related VT. We undertook the Norwegian VIP study, a case-control study of VT in pregnancy or within 3 months postpartum (cases, n = 313) and women without pregnancy-related VT (controls, n = 353). Determinants of C3 and C4 in the control women were investigated with linear regression and the odds ratio (OR) for pregnancy-related VT was calculated with logistic regression. We found that levels of C3 and C4 were associated with body mass index (BMI), C-reactive protein (CRP); with the coagulation factors (F) fibrinogen, FVIII, and FIX; and with the coagulation inhibitors antithrombin, protein C, protein S, and tissue factor pathway inhibitor. These associations were influenced by CRP levels. The crude OR for pregnancy-related VT was 1.8 (95% confidence interval [CI], 1.1-3.0) for C3 above the 90th percentile and 2.0 (95% CI, 1.2-3.2) for C4 above the 90th percentile. Stratification in antenatal and postnatal VT showed that C3 and C4 were only associated with postnatal VT with an OR for high C3 of 3.0 (95% CI, 1.8-5.0), and for high C4 of 2.6 (95% CI, 1.5-4.6). Adjustment for high FIX and BMI reduced the ORs. We conclude that the association between postnatal VT and C3 and C4 suggests that there is clinically relevant crosstalk between the complement and the coagulation system.

Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

INTRODUCTION: The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM. METHODS AND ANALYSIS: This randomised controlled trial will include 230 pregnant women with GDM followed up at 5 outpatient departments (OPD) in the greater Oslo Region. Women with a 2-hour oral glucose tolerance test (OGTT) ≥9 mmol/L, who own a smartphone, understand Norwegian, Urdu or Somali and are <33 weeks pregnant, are invited. The intervention group receives the Pregnant+ app and standard care. The control group receives standard care only. Block randomisation is performed electronically. Data are collected using self-reported questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. Groups will be compared using linear regression for the main outcome and χ2 test for categorical data and Student's t-test or Mann-Whitney-Wilcoxon test for skewed distribution. The main outcome is the glucose level measured at the 2-hour OGTT 3 months postpartum. Secondary outcomes are a change in health behaviour and knowledge about GDM, quality of life, birth weight, mode of delivery and complications for mother and child. ETHICS AND DISSEMINATION: The study is exempt from regional ethics review due to its nature of quality improvement in patient care. Our study has been approved by the Norwegian Social Science Data Services and the patient privacy protections boards governing over the recruitment sites. Findings will be presented in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: NCT02588729, Post-results.

Risk factors for severe postpartum hemorrhage: a case-control study.

BACKGROUND: In high-income countries, the incidence of severe postpartum hemorrhage (PPH) has increased. This has important public health relevance because severe PPH is a leading cause of major maternal morbidity. However, few studies have identified risk factors for severe PPH within a contemporary obstetric cohort. METHODS: We performed a case-control study to identify risk factors for severe PPH among a cohort of women who delivered at one of three hospitals in Norway between 2008 and 2011. A case (severe PPH) was classified by an estimated blood loss ≥1500 mL or the need for blood transfusion for excessive postpartum bleeding. Using logistic regression, we applied a pragmatic strategy to identify independent risk factors for severe PPH. RESULTS: Among a total of 43,105 deliveries occurring between 2008 and 2011, we identified 1064 cases and 2059 random controls. The frequency of severe PPH was 2.5% (95% confidence interval (CI): 2.32-2.62). The most common etiologies for severe PPH were uterine atony (60%) and placental complications (36%). The strongest risk factors were a history of severe PPH (adjusted OR (aOR) = 8.97, 95% CI: 5.25-15.33), anticoagulant medication (aOR = 4.79, 95% CI: 2.72-8.41), anemia at booking (aOR = 4.27, 95% CI: 2.79-6.54), severe pre-eclampsia or HELLP syndrome (aOR = 3.03, 95% CI: 1.74-5.27), uterine fibromas (aOR = 2.71, 95% CI: 1.69-4.35), multiple pregnancy (aOR = 2.11, 95% CI: 1.39-3.22) and assisted reproductive technologies (aOR = 1.88, 95% CI: 1.33-2.65). CONCLUSIONS: Based on our findings, women with a history of severe PPH are at highest risk of severe PPH. As well as other established clinical risk factors for PPH, a history of severe PPH should be included as a risk factor in the development and validation of prediction models for PPH.

Women's values and preferences and health state valuations for thromboprophylaxis during pregnancy: A cross-sectional interview.

BACKGROUND: Pregnant women with prior venous thromboembolism (VTE) are at risk of recurrence. Prophylaxis with low molecular weight heparin (LWMH) reduces that risk but is inconvenient, costly, and may be associated with increased risks of obstetrical bleeding. The views of pregnant women, crucial when making prophylaxis recommendations, are currently unknown. METHODS: Cross-sectional international multicenter study. We included women with a history of VTE who were either pregnant or planning pregnancy. We provided information regarding risk of VTE recurrence with and without LMWH and determined participant's willingness to receive LMWH prophylaxis through direct choice exercises, preference-elicitation (utilities) for health states (e.g. burden of LMWH prophylaxis), and a probability trade-off exercise. RESULTS: Of 123 women, more women at high risk than those at low risk of recurrence (86.4% vs. 60.0%; p = 0.003) chose to use LMWH. The median threshold reduction in VTE at which women were willing to accept use of LMWH, given a 16% risk of VTE without prophylaxis, was 3% (interquartile range: 1 to 6). Participants' evaluation of the relevant health states varied widely and was unrelated to their direct choices to use or not use LMWH. CONCLUSIONS: Although the majority of women with a previous VTE, pregnant or planning pregnancy choose to take LMWH during pregnancy, a minority ­and in low risk women, a large minority­ do not. Our results highlight the need for individualized shared decision-making (SDM) in the clinical encounter, and for guideline panels to make weak recommendations in favor of LMWH that make clear the need for SDM.