Randomised controlled trial of preconception lifestyle intervention on maternal and offspring health in people with increased risk of gestational diabetes: study protocol for the BEFORE THE BEGINNING trial.

INTRODUCTION: Gestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes in the mother and cardiometabolic diseases in the child. The preconception period is an optimal window to adapt the lifestyle for improved outcomes for both mother and child. Our aim is to determine the effect of a lifestyle intervention, initiated before and continued throughout pregnancy, on maternal glucose tolerance and other maternal and infant cardiometabolic outcomes. METHODS AND ANALYSIS: This ongoing randomised controlled trial has included 167 females aged 18-39 years old at increased risk for GDM who are contemplating pregnancy. The participants were randomly allocated 1:1 to an intervention or control group. The intervention consists of exercise (volume is set by a heart rate-based app and corresponds to ≥ 1 hour of weekly exercise at ≥ 80% of individual heart rate maximum), and time-restricted eating (≤ 10 hours/day window of energy intake). The primary outcome measure is glucose tolerance in gestational week 28. Maternal and offspring outcomes are measured before and during pregnancy, at delivery, and at 6-8 weeks post partum. Primary and secondary continuous outcome measures will be compared between groups based on the 'intention to treat' principle using linear mixed models. ETHICS AND DISSEMINATION: The Regional Committees for Medical and Health Research Ethics in Norway has approved the study (REK 143756). The anonymised results will be submitted for publication and posted in a publicly accessible database of clinical study results. TRIAL REGISTRATION NUMBER: Clinical trial gov NCT04585581.

A population-based study of caesarean section in women with juvenile idiopathic arthritis.

Objectives: The literature on delivery methods in women with JIA is limited. Active inflammation is a risk factor for caesarean section (CS) in other arthritic diseases. A CS entails a higher risk for complications than vaginal delivery and restricted physical activity in the first weeks after birth. Our objective was to explore a possible association of inflammatory active disease and the proportion of CS in women with JIA. Methods: Data from the Norwegian nationwide observational register RevNatus were linked with data from the Medical Birth Registry of Norway (MBRN). Cases comprised singleton births in women with JIA (n = 196) included in RevNatus from 2010 to 2019. Singleton births registered in the MBRN during the same period of time, excluding births in mothers with rheumatic inflammatory diseases, served as population controls (n = 575 798). Results: CS was more frequent in women with JIA (20.4%) and in the subgroup of women with inflammatory active JIA (30.0%) than in population controls (15.6%). Women with active JIA had a risk for elective CS similar to population controls [risk difference 2.3% (95% CI -2.5, 12.9)] and a higher risk for emergency CS [risk difference 14.0% (95% CI 4.3, 27.4)] compared with population controls. Conclusion: Women with active JIA had a higher risk for emergency CS, but not elective CS, compared with population controls.

Does regular antenatal exercise promote exclusive breastfeeding during the first 3 months of life? Secondary analyses of a randomized controlled trial.

INTRODUCTION: Exclusive breastfeeding (EBF) and antenatal exercise are independently associated with positive short- and long-term health effects for women and their children. The aims of the study were to investigate whether antenatal exercise promotes EBF three months postpartum and further to explore factors associated with EBF at three months postpartum. METHODS: This study was a follow-up of a Norwegian two-center randomized controlled trial to assess the effect of an antenatal exercise protocol. The recruited pregnant women were randomized to either a 12-week standardized antenatal exercise program with one weekly group training led by a physiotherapist and two weekly home training sessions or standard antenatal care. Women reported breastfeeding status in a questionnaire at three months postpartum. RESULTS: Of the 726 women, 88% were EBF at three months postpartum. There was no significant difference in EBF rates between the intervention group (87%) and the control group (89%). EBF was positively associated with maternal education (AOR=3.4; 95% CI: 1.7-6.7) and EBF at discharge from the hospital (AOR=22.2; 95% CI: 10-49). Admission to neonatal intensive care unit was identified as a significant barrier to EBF (AOR=0.2; 95% CI: 0.1-0.4). Significantly more women in the non-EBF group had sought professional help compared to women in the EBF group (p≤0.001). CONCLUSIONS: Regular physical exercise during pregnancy did not influence the exclusive breastfeeding rates at three months postpartum. Considering the health effects of exclusive breastfeeding and antenatal physical exercise, studies with follow-up periods beyond three months postpartum are warranted.

Ultrasound examination of the pelvic floor during active labor: A longitudinal cohort study.

INTRODUCTION: There is limited evidence about changes in the pelvic floor during active labor. We aimed to investigate changes in hiatal dimensions during the active first stage of labor and associations with fetal descent and head position. MATERIAL AND METHODS: We conducted a longitudinal, prospective cohort study at the National University Hospital of Iceland, from 2016 to 2018. Nulliparous women with spontaneous onset of labor, a single fetus in cephalic presentation, and gestational age ≥37 weeks were eligible. Fetal position was assessed with transabdominal ultrasound and fetal descent was measured with transperineal ultrasound. Three-dimensional volumes were acquired from transperineal scanning at the start of the active phase of labor and in late first stage or early second stage. The largest transverse hiatal diameter was measured in the plane of minimal hiatal dimensions. The levator urethral gap was measured as the distance between the center of the urethra and the levator insertion using tomographic ultrasound imaging. Measurements of the levator urethral gap were made in the plane of minimal hiatal dimensions and 2.5 and 5 mm cranial to this. RESULTS: The final study population comprised 78 women. The mean transverse hiatal diameter increased 12.4% between the two examinations, from 39.4 ± 4.1 mm (±standard deviation) at the first examination to 44.3 ± 5.8 mm at the last examination (p < 0.01). We found a moderate correlation between the transverse hiatal diameter and fetal station at the last examination (r = 0.44, r2 = 0.19; p < 0.01; regression equation y = 2.71 + 0.014x), and a weak correlation between the change in transverse hiatal diameter and change in fetal station (r = 0.29; r2 = 0.08; p = 0.01; regression equation y = 0.24 + 0.012x). Levator urethral gap increased significantly in all three planes on both the left and right sides. Head position was not associated with hiatal measurements after adjusting for fetal station. CONCLUSIONS: We found a significant, but only modest, increase of the hiatal dimensions during the first stage of labor. The risk of levator ani trauma will therefore be low during this stage. The change in transverse hiatal diameter was associated with fetal descent but not with head position.

Continuous fetal cerebral blood flow monitoring during labor: A feasibility study.

BACKGROUND: Current methods for fetal surveillance during labor have significant limitations. Since continuous fetal cerebral blood flow velocity (CBFV) monitoring during labor may add valuable information about fetal well-being, we developed a new ultrasound system called VisiBeam. VisiBeam consists of a flat probe (diameter 11 mm) with a cylindric plane wave beam, a vacuum attachment (diameter 40 mm), a scanner, and a display. AIMS: To assess the feasibility of VisiBeam for continuous fetal CBFV monitoring during labor, and to study changes in CBFV during uterine contractions. STUDY DESIGN: Descriptive observational study. SUBJECTS: Twenty-five healthy women in labor with a singleton fetus in cephalic presentation at term. A transducer was placed over a fontanelle and attached to the fetal head with vacuum suction. OUTCOME MEASURES: Achievement of continuous good quality fetal CBFV measures, such as peak systolic velocity, time averaged maximum velocity and end diastolic velocity. Trend plots of velocity measures display changes in CBFV between and during uterine contractions. RESULTS: Good quality recordings during and between contractions were achieved in 16/25 fetuses. In twelve fetuses, CBFV measures were stable during uterine contractions. Four fetuses showed patterns of reduced CBFV velocity measures during contractions. CONCLUSIONS: Continuous fetal CBFV monitoring by VisiBeam was feasible in 64 % of the subjects during labor. The system displayed variations of fetal CBFV not available by today's monitoring techniques and motivates for further studies. However, improvement of the probe attachment is required to ensure good quality signal in a higher proportion of fetuses during labor.

Associations between maternal and offspring glucose metabolism: a 9-year follow-up of a randomised controlled trial.

Introduction: There is increasing evidence that the in utero environment affects the health and disease risk of offspring throughout their lives. The long-term effect of maternal hyperglycaemia on offspring glucose metabolism is of interest in a public health perspective. The aim of this study was to examine the association between in utero exposure to maternal glycaemia and offspring glucose metabolism. Methods: Mother-child pairs were recruited from an RCT to prevent gestational diabetes mellitus where 855 healthy pregnant women were randomised to exercise or standard antenatal care. The original RCT detected no group differences in gestational diabetes mellitus prevalence or insulin resistance. The two groups were analysed as one group in the present study. Maternal glucose levels were assessed after 2-hour 75-gram oral glucose tolerance tests in pregnancy week ~34. Offspring outcomes were evaluated at ~9 years of age and included fasting glucose and homeostatic model assessment of insulin resistance. Multivariable regression models were performed, controlling for potential hereditary and lifestyle confounding factors. Results: Complete data were available for 105 mother-child pairs. The regression analysis showed a positive association between maternal and offspring fasting glucose that was borderline significant (beta=0.18, 95% CI [-0.00027, 0.37], p=0.050). We did not find significant associations between maternal fasting glucose and offspring insulin resistance (beta=0.080, 95% CI [-0.087, 0.25], p=0.34), or between maternal 2-hour glucose and offspring fasting glucose (beta=0.016, 95% CI [-0.038, 0.070], p=0.56) or insulin resistance (beta=0.017, 95% CI [-0.032, 0.065], p=0.49). Conclusions: Assessing a homogeneous group of healthy mother-child pairs, we found a borderline significant positive association between maternal and offspring fasting glucose, which persisted after adjustment for potential hereditary and lifestyle confounding factors. Our findings support other similar studies and highlight that improving the metabolic health of pregnant women, and women in childbearing age, should remain a key public health priority. Clinical trial registration: ClinicalTrials.gov, identifier NCT00476567.

Phosphatidylethanol as Blood Biomarker of Alcohol Consumption in Early Pregnancy: An Observational Study in 4,067 Pregnant Women.

BACKGROUND: The teratogenic effects of alcohol are well documented, but there is a lack of screening methods to detect alcohol use during pregnancy. Phosphatidylethanol 16:0/18:1 (PEth) is a specific and sensitive biomarker reflecting alcohol intake up to several weeks after consumption. The aim of this study was to investigate the prevalence of positive PEth values as an indicator of early prenatal alcohol exposure in a general population of pregnant women. METHODS: Rhesus typing is routinely performed in Norway in all pregnancies around gestational week 12. Rhesus-negative women have an additional test taken around week 24. Blood samples submitted to St. Olav University Hospital in Trøndelag, Norway, for Rhesus typing during the period September 2017 to October 2018 were collected. A total of 4,533 whole blood samples from 4,067 women were analyzed for PEth (limit of quantification of 0.003 µM). RESULTS: Fifty-eight women had a positive PEth sample. Of these, 50 women were positive around gestational week 12, 3 women were positive around week 24, and in 5 cases, the timing was unknown. There were no significant differences in proportions of women with positive PEth values related to age, or rural versus urban residency. CONCLUSION: In an unselected pregnant population in Norway, 1.4% had a positive PEth sample around gestational week 12, whereas 0.4% had a positive sample around week 24. The use of PEth as an alcohol biomarker should be further investigated as a diagnostic tool in the antenatal setting.

Regular antenatal exercise including pelvic floor muscle training reduces urinary incontinence 3 months postpartum-Follow up of a randomized controlled trial.

INTRODUCTION: Urinary incontinence is a frequently reported condition among women with pregnancy and delivery as established risk factors. The aims of this study were to evaluate the effect of an antenatal exercise program including pelvic floor muscle training on postpartum urinary incontinence, and to explore factors associated with urinary incontinence three months postpartum. MATERIAL AND METHODS: This is a short-term follow-up and secondary analysis of a randomized controlled trial conducted at two Norwegian University Hospitals including healthy, pregnant women aged >18 years with a singleton live fetus. Women in the exercise group received a 12-week standardized exercise program including pelvic floor muscle training, with once weekly group exercise classes led by a physiotherapist and twice weekly home exercise sessions. The controls received standard antenatal care. Data were obtained from questionnaires answered in pregnancy weeks 18-22, and three months postpartum. Urinary incontinence prevalence in the exercise and control groups was compared, and multivariable logistic regression analyses were applied. Urinary incontinence prevalence three months postpartum was assessed by the Sandvik severity index. RESULTS: Among the 722 (84%) women who responded three months postpartum, significantly fewer women in the exercise group (29%) reported urinary incontinence compared with the standard antenatal care group (38%, P = .01). Among women who were incontinent at baseline, 44% and 59% (P = .014) were incontinent at three months postpartum in the exercise and control groups, respectively. Urinary incontinence three months postpartum was associated with age (OR 1.1, 95% CI 1.0-1.1), experiencing urinary incontinence in late pregnancy (OR 3.6, 95% CI 2.3-5.9), birthweight ≥4000 g (OR 1.8, 95% CI 1.2-2.8), and obstetric anal sphincter injuries (OR 2.6, 95% CI 1.1-6.1). Cesarean section significantly reduced the risk of urinary incontinence three months postpartum compared with spontaneous vaginal delivery (OR 0.2, 95% CI 0.1-0.5). CONCLUSIONS: A moderate-intensity exercise program including pelvic floor muscle training reduced prevalence of urinary incontinence 3 months postpartum in women who were incontinent at baseline.

Factors Associated With Time to Pregnancy in Women With Axial Spondyloarthritis: A Registry-Based Multicenter Study.

OBJECTIVE: The present study was undertaken to study time to pregnancy (TTP) and factors associated with TTP in women with axial spondyloarthritis (SpA) compared to women with rheumatoid arthritis (RA). METHODS: We included 274 women with axial SpA and 317 women with RA from the Norwegian nationwide registry RevNatus. For all the women, we had retrospectively collected data on TTP, and a subgroup also had prospectively collected data. We compared TTP in women with axial SpA to women with RA using Kaplan-Meier plots and a log rank test. To identify factors associated with TTP, we used Cox proportional hazards regression. RESULTS: TTP exceeded 12 months in 21% of women with axial SpA. In the subgroup followed prospectively, 32% had TTP that exceeded 12 months. Longer TTP was associated with older age, nulliparity, and longer disease duration, with hazard ratios of 0.97 (95% confidence interval [95% CI] 0.94-1.00), 0.66 (95% CI 0.50-0.88), and 0.94 (95% CI 0.91-0.98), respectively. Disease activity, medication, and self-reported health-related quality of life were not associated with TTP. We found no statistically significant differences between axial SpA and RA in regard to TTP. CONCLUSION: In women with axial SpA, longer TTP was associated with older age, nulliparity, and longer disease duration.

Validation and development of models using clinical, biochemical and ultrasound markers for predicting pre-eclampsia: an individual participant data meta-analysis.

BACKGROUND: Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk is needed to plan management. OBJECTIVES: To assess the performance of existing pre-eclampsia prediction models and to develop and validate models for pre-eclampsia using individual participant data meta-analysis. We also estimated the prognostic value of individual markers. DESIGN: This was an individual participant data meta-analysis of cohort studies. SETTING: Source data from secondary and tertiary care. PREDICTORS: We identified predictors from systematic reviews, and prioritised for importance in an international survey. PRIMARY OUTCOMES: Early-onset (delivery at < 34 weeks' gestation), late-onset (delivery at ≥ 34 weeks' gestation) and any-onset pre-eclampsia. ANALYSIS: We externally validated existing prediction models in UK cohorts and reported their performance in terms of discrimination and calibration. We developed and validated 12 new models based on clinical characteristics, clinical characteristics and biochemical markers, and clinical characteristics and ultrasound markers in the first and second trimesters. We summarised the data set-specific performance of each model using a random-effects meta-analysis. Discrimination was considered promising for C-statistics of ≥ 0.7, and calibration was considered good if the slope was near 1 and calibration-in-the-large was near 0. Heterogeneity was quantified using I2 and τ2. A decision curve analysis was undertaken to determine the clinical utility (net benefit) of the models. We reported the unadjusted prognostic value of individual predictors for pre-eclampsia as odds ratios with 95% confidence and prediction intervals. RESULTS: The International Prediction of Pregnancy Complications network comprised 78 studies (3,570,993 singleton pregnancies) identified from systematic reviews of tests to predict pre-eclampsia. Twenty-four of the 131 published prediction models could be validated in 11 UK cohorts. Summary C-statistics were between 0.6 and 0.7 for most models, and calibration was generally poor owing to large between-study heterogeneity, suggesting model overfitting. The clinical utility of the models varied between showing net harm to showing minimal or no net benefit. The average discrimination for IPPIC models ranged between 0.68 and 0.83. This was highest for the second-trimester clinical characteristics and biochemical markers model to predict early-onset pre-eclampsia, and lowest for the first-trimester clinical characteristics models to predict any pre-eclampsia. Calibration performance was heterogeneous across studies. Net benefit was observed for International Prediction of Pregnancy Complications first and second-trimester clinical characteristics and clinical characteristics and biochemical markers models predicting any pre-eclampsia, when validated in singleton nulliparous women managed in the UK NHS. History of hypertension, parity, smoking, mode of conception, placental growth factor and uterine artery pulsatility index had the strongest unadjusted associations with pre-eclampsia. LIMITATIONS: Variations in study population characteristics, type of predictors reported, too few events in some validation cohorts and the type of measurements contributed to heterogeneity in performance of the International Prediction of Pregnancy Complications models. Some published models were not validated because model predictors were unavailable in the individual participant data. CONCLUSION: For models that could be validated, predictive performance was generally poor across data sets. Although the International Prediction of Pregnancy Complications models show good predictive performance on average, and in the singleton nulliparous population, heterogeneity in calibration performance is likely across settings. FUTURE WORK: Recalibration of model parameters within populations may improve calibration performance. Additional strong predictors need to be identified to improve model performance and consistency. Validation, including examination of calibration heterogeneity, is required for the models we could not validate. STUDY REGISTRATION: This study is registered as PROSPERO CRD42015029349. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 72. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Pre-eclampsia, a condition in pregnancy that results in raised blood pressure and protein in the urine, is a major cause of complications for the mother and baby. WHAT IS NEEDED?: A way of accurately identifying women at high risk of pre-eclampsia to allow clinicians to start preventative interventions such as administering aspirin or frequently monitoring women during pregnancy. WHERE ARE THE RESEARCH GAPS?: Although over 100 tools (models) have been reported worldwide to predict pre-eclampsia, to date their performance in women managed in the UK NHS is unknown. WHAT DID WE PLAN TO DO?: We planned to comprehensively identify all published models that predict the risk of pre-eclampsia occurring at any time during pregnancy and to assess if this prediction is accurate in the UK population. If the existing models did not perform satisfactorily, we aimed to develop new prediction models. WHAT DID WE FIND?: We formed the International Prediction of Pregnancy Complications network, which provided data from a large number of studies (78 studies, 25 countries, 125 researchers, 3,570,993 singleton pregnancies). We were able to assess the performance of 24 out of the 131 models published to predict pre-eclampsia in 11 UK data sets. The models did not accurately predict the risk of pre-eclampsia across all UK data sets, and their performance varied within individual data sets. We developed new prediction models that showed promising performance on average across all data sets, but their ability to correctly identify women who develop pre-eclampsia varied between populations. The models were more clinically useful when used in the care of first-time mothers pregnant with one child, compared to a strategy of treating them all as if they were at high-risk of pre-eclampsia. WHAT DOES THIS MEAN?: Before using the International Prediction of Pregnancy Complications models in various populations, they need to be adjusted for characteristics of the particular population and the setting of application.

External validation of prognostic models predicting pre-eclampsia: individual participant data meta-analysis.

BACKGROUND: Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk during pregnancy is required to plan management. Although there are many published prediction models for pre-eclampsia, few have been validated in external data. Our objective was to externally validate published prediction models for pre-eclampsia using individual participant data (IPD) from UK studies, to evaluate whether any of the models can accurately predict the condition when used within the UK healthcare setting. METHODS: IPD from 11 UK cohort studies (217,415 pregnant women) within the International Prediction of Pregnancy Complications (IPPIC) pre-eclampsia network contributed to external validation of published prediction models, identified by systematic review. Cohorts that measured all predictor variables in at least one of the identified models and reported pre-eclampsia as an outcome were included for validation. We reported the model predictive performance as discrimination (C-statistic), calibration (calibration plots, calibration slope, calibration-in-the-large), and net benefit. Performance measures were estimated separately in each available study and then, where possible, combined across studies in a random-effects meta-analysis. RESULTS: Of 131 published models, 67 provided the full model equation and 24 could be validated in 11 UK cohorts. Most of the models showed modest discrimination with summary C-statistics between 0.6 and 0.7. The calibration of the predicted compared to observed risk was generally poor for most models with observed calibration slopes less than 1, indicating that predictions were generally too extreme, although confidence intervals were wide. There was large between-study heterogeneity in each model's calibration-in-the-large, suggesting poor calibration of the predicted overall risk across populations. In a subset of models, the net benefit of using the models to inform clinical decisions appeared small and limited to probability thresholds between 5 and 7%. CONCLUSIONS: The evaluated models had modest predictive performance, with key limitations such as poor calibration (likely due to overfitting in the original development datasets), substantial heterogeneity, and small net benefit across settings. The evidence to support the use of these prediction models for pre-eclampsia in clinical decision-making is limited. Any models that we could not validate should be examined in terms of their predictive performance, net benefit, and heterogeneity across multiple UK settings before consideration for use in practice. TRIAL REGISTRATION: PROSPERO ID: CRD42015029349 .

Prevalence of anal sphincter defects and association with anal incontinence in women scheduled for pelvic organ prolapse surgery.

AIMS: Some women with pelvic organ prolapse (POP) have concomitant symptoms of anal incontinence. Our aim was to assess the prevalence of anal sphincter defects and the association with incontinence in women undergoing POP surgery. METHODS: Cross-sectional study of 200 women scheduled for POP surgery. They answered yes/no and graded any symptoms of fecal and flatal incontinence on a visual analog scale (0-100). 3D/4D transperineal ultrasound was used to assess internal (IAS) and external anal sphincter (EAS) defects. A defect of ≥30° in ≥4 of 6 slices on tomographic imaging was regarded significant. The association between incontinence and sphincter defects was tested with multivariable logistic regression analysis. RESULTS: The prevalence of any sphincter defect was 50/200 (25%). Combined IAS/EAS defect was found in 19/200 (9.5%) women, 8/200 (4.0%) had isolated IAS, and 23/200 (11.5%) had isolated EAS defects. In women with defect and intact IAS, 37% and 11% reported fecal incontinence, respectively, adjusted odds ratio (aOR) 2.3 (95% confidence interval [CI], 0.7-7.0), p = .147 and in women with defect versus intact EAS, 36% and 9% had fecal incontinence, aOR 4.0 (95% CI, 1.5-10.8), p = .005. In women with defect and intact IAS, 85% versus 43% reported flatal incontinence, aOR 5.2 (95% CI, 1.6-17.2), p = .007 and in women with defect versus intact EAS, 71% versus 43% had flatal incontinence, aOR 1.9 (95% CI, 0.8-4.5), p = .131. CONCLUSIONS: One of four women scheduled for POP surgery had an anal sphincter defect. EAS defects were associated with fecal incontinence and IAS defects were strongly associated with flatal incontinence.

Gestational weight gain outside the Institute of Medicine recommendations and adverse pregnancy outcomes: analysis using individual participant data from randomised trials.

BACKGROUND: High Body Mass Index (BMI) and gestational weight gain (GWG) affect an increasing number of pregnancies. The Institute of Medicine (IOM) has issued recommendations on the optimal GWG for women according to their pre-pregnancy BMI (healthy, overweight or obese). It has been shown that pregnant women rarely met the recommendations; however, it is unclear by how much. Previous studies also adjusted the analyses for various women's characteristics making their comparison challenging. METHODS: We analysed individual participant data (IPD) of healthy women with a singleton pregnancy and a BMI of 18.5 kg/m2 or more from the control arms of 36 randomised trials (16 countries). Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were used to describe the association between GWG outside (above or below) the IOM recommendations (2009) and risks of caesarean section, preterm birth, and large or small for gestational age (LGA or SGA) infants. The association was examined overall, within the BMI categories and by quartile of GWG departure from the IOM recommendations. We obtained aOR using mixed-effects logistic regression, accounting for the within-study clustering and a priori identified characteristics. RESULTS: Out of 4429 women (from 33 trials) meeting the inclusion criteria, two thirds gained weight outside the IOM recommendations (1646 above; 1291 below). The median GWG outside the IOM recommendations was 3.1 kg above and 2.7 kg below. In comparison to GWG within the IOM recommendations, GWG above was associated with increased odds of caesarean section (aOR 1.50; 95%CI 1.25, 1.80), LGA (2.00; 1.58, 2.54), and reduced odds of SGA (0.66; 0.50, 0.87); no significant effect on preterm birth was detected. The relationship between GWG below the IOM recommendation and caesarean section or LGA was inconclusive; however, the odds of preterm birth (1.94; 1.31, 2.28) and SGA (1.52; 1.18, 1.96) were increased. CONCLUSIONS: Consistently with previous findings, adherence to the IOM recommendations seem to help achieve better pregnancy outcomes. Nevertheless, even in the context of clinical trials, women find it difficult to adhere to them. Further research should focus on identifying ways of achieving a healthier GWG as defined by the IOM recommendations.

Levator ani muscle injury and risk for urinary and fecal incontinence in parous women from a normal population, a cross-sectional study.

AIMS: To study possible associations between levator ani muscle (LAM) injury and urinary incontinence (UI) and fecal incontinence (FI) and possible associations between bladder neck descent (BND), urethral funneling, and UI. METHODS: A cross-sectional study of 608 women with first delivery in 1990 to 1997 assessed in 2013 to 2014. The Urinary Distress Inventory (UDI-6) and Colorectal Anal Distress Inventory (CRADI-8) were used to quantify symptoms (range, 0-100). The proportion of women with UI and FI was calculated. LAM injury, BND ≥25 mm, and funneling were diagnosed with transperineal ultrasound. Women with LAM injury, BND, and urethral funneling were compared to those without, using the Mann-Whitney U test (symptom scores) and multiple logistic regression analysis (UI and FI). RESULTS: Four-hundred ninety-three (81%) women had intact LAM and 113 (19%) had LAM injury. They had similar median (range) UDI-6 score 8.3 (0-75) vs 4.2 (0-62.5), P = .35, and CRADI-8 score 6.3 (0-78.1) vs 6.3 (0-62.5), P = .90. Three hundred eleven out of six hundred (52%) women had UI and 65 of 594 (11%) had FI. This was similar for women with intact vs injured LAM; UI 53% vs 49%, P = .67; FI 11% vs 12%, P = .44 and with and without BND; stress UI 42% vs 42%, P = .93; urge UI 29% vs 35%, P = .34. Stress UI was more common in women with urethral funneling (50% vs 40%), odds ratio 1.56 (95% confidence interval: 1.03-2.37), P = .04. CONCLUSION: We found no associations between LAM injury and symptoms of UI and FI 15 to 24 years after the first delivery, but urethral funneling was associated with stress UI.

Impact of maternal education on response to lifestyle interventions to reduce gestational weight gain: individual participant data meta-analysis.

OBJECTIVES: To identify if maternal educational attainment is a prognostic factor for gestational weight gain (GWG), and to determine the differential effects of lifestyle interventions (diet based, physical activity based or mixed approach) on GWG, stratified by educational attainment. DESIGN: Individual participant data meta-analysis using the previously established International Weight Management in Pregnancy (i-WIP) Collaborative Group database (https://iwipgroup.wixsite.com/collaboration). Preferred Reporting Items for Systematic reviews and Meta-Analysis of Individual Participant Data Statement guidelines were followed. DATA SOURCES: Major electronic databases, from inception to February 2017. ELIGIBILITY CRITERIA: Randomised controlled trials on diet and physical activity-based interventions in pregnancy. Maternal educational attainment was required for inclusion and was categorised as higher education (≥tertiary) or lower education (≤secondary). RISK OF BIAS: Cochrane risk of bias tool was used. DATA SYNTHESIS: Principle measures of effect were OR and regression coefficient. RESULTS: Of the 36 randomised controlled trials in the i-WIP database, 21 trials and 5183 pregnant women were included. Women with lower educational attainment had an increased risk of excessive (OR 1.182; 95% CI 1.008 to 1.385, p =0.039) and inadequate weight gain (OR 1.284; 95% CI 1.045 to 1.577, p =0.017). Among women with lower education, diet basedinterventions reduced risk of excessive weight gain (OR 0.515; 95% CI 0.339 to 0.785, p = 0.002) and inadequate weight gain (OR 0.504; 95% CI 0.288 to 0.884, p=0.017), and reduced kg/week gain (B -0.055; 95% CI -0.098 to -0.012, p=0.012). Mixed interventions reduced risk of excessive weight gain for women with lower education (OR 0.735; 95% CI 0.561 to 0.963, p=0.026). Among women with high education, diet based interventions reduced risk of excessive weight gain (OR 0.609; 95% CI 0.437 to 0.849, p=0.003), and mixed interventions reduced kg/week gain (B -0.053; 95% CI -0.069 to -0.037,p<0.001). Physical activity based interventions did not impact GWG when stratified by education. CONCLUSIONS: Pregnant women with lower education are at an increased risk of excessive and inadequate GWG. Diet based interventions seem the most appropriate choice for these women, and additional support through mixed interventions may also be beneficial.

Impact of job adjustment, pain location and exercise on sick leave due to lumbopelvic pain in pregnancy: a longitudinal study.

Objective: To identify factors associated with sick leave due to lumbopelvic pain (LPP) in pregnancy. Design: Prospective cohort study using participants from a randomized controlled trial (RCT) designed to study the effect of exercise during pregnancy on pregnancy related diseases. Setting: St. Olavs Hospital, Trondheim University Hospital and Stavanger University Hospital, April 2007 to December 2009. Subjects: Healthy pregnant women. Main outcome measures: Self-reported sick leave due to LPP in late pregnancy (gestation week 32-36). Results: In total, 532/716 (74%) women reported LPP at 32-36 weeks of pregnancy, and 197/716 (28%) reported sick leave due to LPP. Not receiving job adjustments when needed (Odds ratio, OR with 95% confidence interval, CI, was 3.0 (1.7-5.4)) and having any pain in the pelvic girdle versus no pain (OR 2.7 (1.3-5.6), OR 2.7 (1.4-5.2) and OR 2.2 (1.04-4.8)) for anterior, posterior and combined anterior and posterior pain in the pelvis respectively, were associated with sick leave due to LPP in late pregnancy. Also higher disability, sick listed due to LPP at inclusion and lower education, were significant explanatory variables. There was a trend of reduced risk for sick leave due to LPP when allocated to the exercise group in the original RCT (OR 0.7 (0.4-1.0)). Conclusion: Facilitating job adjustments when required might keep more pregnant women in employment. Furthermore, pain locations in pelvic area, disability, lower education and being sick listed due to LPP in mid pregnancy are important risk factors for sick leave in late pregnancy. Key points Current awareness: More than half of pregnant women are on sick leave during pregnancy and the most frequently reported cause is lumbopelvic pain. This paper adds: Inability to make job adjustments, pain locations in pelvic area, disability and lower education level were the most important risk factors for sick leave in late pregnancy. Facilitating early job adjustment might be a precaution to keep more pregnant women in work. Allocation to an exercise group tended to reduce the risk of sick leave in late pregnancy.Registration number: Clinical trial gov (NCT00476567).

Dietary Intakes and Dietary Quality during Pregnancy in Women with and without Gestational Diabetes Mellitus-A Norwegian Longitudinal Study.

Gestational diabetes mellitus (GDM) is associated with maternal diet, however, findings are inconsistent. The aims of the present study were to assess whether intakes of foods and beverages during pregnancy differed between women who developed GDM and non-GDM women, and to compare dietary intakes with dietary recommendations of pregnancy. This is a nested case-control study within a randomized controlled trial. Women with complete measurements of a 75 g oral glucose tolerance test (OGTT) at 18⁻22 and 32⁻36 weeks gestation were included in the cohort (n = 702). Women were diagnosed for GDM according to the simplified International Association of Diabetes and Pregnancy Study Group criteria at 32⁻36 weeks (GDM women: n = 40; non-GDM women: n = 662). Dietary data (food frequency questionnaire) was collected at both time points and compared between GDM and non-GDM women. Variability in OGTT values was assessed in a general linear model. Marginal differences between GDM and non-GDM women in intakes of food groups were found. No associations were found between dietary variables and OGTT values. Not all dietary recommendations were followed in the cohort, with frequently reported alcohol consumption giving largest cause for concern. This study did not find dietary differences that could help explain why 40 women developed GDM.

Fetal rotation during vacuum extractions for prolonged labor: a prospective cohort study.

INTRODUCTION: The aim of the study was to investigate fetal head rotation during vacuum extraction. MATERIAL AND METHODS: We conducted a prospective cohort study from November 2013 to July 2016 in seven European hospitals. Fetal head position was determined with transabdominal or transperineal ultrasound and categorized as occiput anterior (OA), occiput transverse (OT) or occiput posterior (OP) position. Main outcome was the proportion of fetuses rotating during vacuum extraction. Secondary outcomes were conversion of delivery method, duration of vacuum extraction, umbilical artery pH <7.10 and agreement between clinical and ultrasound assessments. RESULTS: The study population comprised 165 women. During vacuum extraction 117/119 (98%) remained in OA and two fetuses rotated to OP position. Rotation from OT to OA position occurred in 14/19 (74%) and to OP position in 5/19 (26%). Rotation from OP to OA position occurred in 15/25 (60%), and 10/25 (40%) fetuses remained in OP position. Delivery information was missing in two cases. The conversion rate from vacuum extraction to cesarean section or forceps was 10% in the OA group vs. 23% in the non-OA group; p < 0.05. The estimated duration of vacuum extraction was significantly shorter in OA fetuses, 7 min vs. 10 min (log rank test p < 0.01). There was no significant difference in umbilical artery pH < 7.10 between OA and non-OA position. Cohens Kappa of agreement between clinical and ultrasound assessments was 0.42 (95% CI 0.26-0.57). CONCLUSION: Most fetuses in OP or OT positions rotated to OA position during vacuum extraction, but the proportion of failed vacuum extractions remained high.