Perinatal morbidity among women with a previous caesarean delivery (PRISMA trial): a cluster-randomised trial.

BACKGROUND: Women with a previous caesarean delivery face a difficult choice in their next pregnancy: planning another caesarean or attempting vaginal delivery, both of which are associated with potential maternal and perinatal complications. This trial aimed to assess whether a multifaceted intervention, which promoted person-centred decision making and best practices, would reduce the risk of major perinatal morbidity among women with one previous caesarean delivery. METHODS: We conducted an open, multicentre, cluster-randomised, controlled trial of a multifaceted 2-year intervention in 40 hospitals in Quebec among women with one previous caesarean delivery, in which hospitals were the units of randomisation and women the units of analysis. Randomisation was stratified according to level of care, using blocked randomisation. Hospitals were randomly assigned (1:1) to the intervention group (implementation of best practices and provision of tools that aimed to support decision making about mode of delivery, including an estimation of the probability of vaginal delivery and an ultrasound estimation of the risk of uterine rupture), or the control group (no intervention). The primary outcome was a composite risk of major perinatal morbidity. This trial was registered with ISRCTN, ISRCTN15346559. FINDINGS: 21 281 eligible women delivered during the study period, from April 1, 2016 to Dec 13, 2019 (10 514 in the intervention group and 10 767 in the control group). None were lost to follow-up. There was a significant reduction in the rate of major perinatal morbidity from the baseline period to the intervention period in the intervention group as compared with the control group (adjusted odds ratio [OR] for incremental change over time, 0·72 [95% CI 0·52-0·99]; p=0·042; adjusted risk difference -1·2% [95% CI -2·0 to -0·1]). Major maternal morbidity was significantly reduced in the intervention group as compared with the control group (adjusted OR 0·54 [95% CI 0·33-0·89]; p=0·016). Minor perinatal and maternal morbidity, caesarean delivery, and uterine rupture rates did not differ significantly between groups. INTERPRETATION: A multifaceted intervention supporting women in their choice of mode of delivery and promoting best practices resulted in a significant reduction in rates of major perinatal and maternal morbidity, without an increase in the rate of caesarean or uterine rupture. FUNDING: Canadian Institutes of Health Research (CIHR, MOP-142448).

Relation Between Initiation of Breastfeeding Success and Postpartum Depression.

OBJECTIVES: This study was designed to assess the effect of initiation of breastfeeding success on postpartum depression (PPD) among women who gave birth in Quebec. METHODS: Secondary analysis of the "Quality of Care, Obstetrics Risk Management, and Mode of Delivery" trial (QUARISMA trial), conducted in Quebec from 1 April 2008 to 31 October 2011 to reduce rates of cesarean delivery in Quebec. INCLUSION CRITERIA: all women ≥18 years old who gave birth at the hospital of a single baby ≥370 weeks of gestation. Logistic regression was performed to investigate the impact of initiation of breastfeeding success on PPD rates. Outcome was reported using adjusted ORs with 95% CIs. RESULTS: A total of 151 708 women (21 525 women with unsuccessful initiation of breastfeeding and 130 183 women with successful initiation of breastfeeding) were selected to participate in this study. We observed a significant association between initiation of breastfeeding success and a lower rate of PPD (0.16% vs. 0.29%) (OR 0.57; 95% CI 0.41-0.79, P < 0.001). CONCLUSIONS: Initiation of breastfeeding success is significantly associated with a lower risk of PPD.

Comparison of National Factor-Based Models for Preeclampsia Screening.

OBJECTIVE: This study aimed to compare the predictive values of the American College of Obstetricians and Gynecologists (ACOG), the National Institute for Health and Care Excellence (NICE), and the Society of Obstetricians and Gynecologists of Canada (SOGC) factor-based models for preeclampsia (PE) screening. STUDY DESIGN: We conducted a secondary analysis of maternal and birth data from 32 hospitals. For each delivery, we calculated the risk of PE according to the ACOG, the NICE, and the SOGC models. Our primary outcomes were PE and preterm PE (PE combined with preterm birth) using the ACOG criteria. We calculated the detection rate (DR or sensitivity), the false positive rate (FPR or 1 - specificity), the positive (PPV) and negative (NPV) predictive values of each model for PE and for preterm PE using receiver operator characteristic (ROC) curves. RESULTS: We used 130,939 deliveries including 4,635 (3.5%) cases of PE and 823 (0.6%) cases of preterm PE. The ACOG model had a DR of 43.6% for PE and 50.3% for preterm PE with FPR of 15.6%; the NICE model had a DR of 36.2% for PE and 41.3% for preterm PE with FPR of 12.8%; and the SOGC model had a DR of 49.1% for PE and 51.6% for preterm PE with FPR of 22.2%. The PPV for PE of the ACOG (9.3%) and NICE (9.4%) models were both superior than the SOGC model (7.6%; p < 0.001), with a similar trend for the PPV for preterm PE (1.9 vs. 1.9 vs. 1.4%, respectively; p < 0.01). The area under the ROC curves suggested that the ACOG model is superior to the NICE for the prediction of PE and preterm PE and superior to the SOGC models for the prediction of preterm PE (all with p < 0.001). CONCLUSION: The current ACOG factor-based model for the prediction of PE and preterm PE, without considering race, is superior to the NICE and SOGC models. KEY POINTS: · Clinical factor-based model can predict PE in approximately 44% of the cases for a 16% false positive.. · The ACOG model is superior to the NICE and SOGC models to predict PE.. · Clinical factor-based models are better to predict PE in parous than in nulliparous..

Optimal Gestational Weight Gain for Women With Obesity.

OBJECTIVE: To determine the optimal gestational weight gain interval for women with obesity in order to minimize neonatal and maternal adverse events. METHODS: Secondary analysis of the QUARISMA trial, including women with obesity who delivered a full-term singleton in cephalic presentation from 2008 to 2011 in Québec. The primary outcome was a composite risk of major neonatal morbidity. Secondary outcomes were composite risks of major maternal morbidity, minor neonatal and maternal morbidity, and cesarean delivery. Various ranges of weight gain were compared with the current recommendations (reference group) using logistic regression to identify an optimal gestational weight gain interval. In a secondary analysis, women with obesity were stratified by obesity class (I-III). RESULTS: Among 16 808 eligible women with obesity, 3270 gained less weight than recommended, 4355 gained weight as recommended (5-9.09 kg), and 9183 gained more weight than recommended. Optimal gestational weight change for all women with obesity was -1 to +4 kg and was associated with reduced risk of major neonatal morbidity (aOR 0.49; 95%CI 0.33-0.73, P < 0.001) compared with the reference group. Analysis by class of obesity showed a reduced risk of major neonatal morbidity with a weight change of -1 to +4 kg for class I, -2 to +2 for class II), and -2 to +3 kg for class III. CONCLUSION: Compared with the current guidelines, a gestational weight change of -1 to +4 kg is associated with reduced risk of adverse perinatal outcomes. While similar findings were seen among women with class I obesity, women with class II or III obesity could benefit from a lower weight gain.

Impact of Third-Trimester Measurement of Low Uterine Segment Thickness and Estimated Fetal Weight on Perinatal Morbidity in Women With Prior Cesarean Delivery.

OBJECTIVES: This study aimed to estimate the impact of third-trimester ultrasound with measurement of the lower uterine segment thickness (LUST) and estimation of fetal weight (EFW) on maternal and perinatal morbidity among women with a prior cesarean delivery. METHODS: We performed a secondary analysis of the QUARISMA trial, including women who delivered at term after one prior cesarean delivery in tertiary care centres. Major and minor maternal and perinatal morbidities were compared between centres that had introduced LUST and EFW measurements into routine practice and those that had not, using generalised estimating equations and adjusted odds ratios (aOR). In a secondary analysis, we compared women who underwent a trial of labour with and without LUST and EFW measurements. RESULTS: We observed a significant reduction in major perinatal morbidity (aOR 0.52; 95% CI 0.28-0.96, P = 0.04), minor perinatal morbidity (aOR 0.49; 95% CI 0.25-0.96, P = 0.04), and minor maternal morbidity (aOR 0.56; 95% CI 0.34- 0.94, P = 0.03) but no significant difference in major maternal morbidity (aOR 0.40; 95% CI 0.04-3.69, P = 0.42) in the 2 centres that had introduced third-trimester ultrasound with EFW and LUST measurements (1458 women), compared with the 4 centres (1247 women) that had not. Among women who underwent a trial of labour, we observed a reduction in major perinatal morbidity (aOR 0.25; 95% CI 0.11-0.54, P < 0.001) and a lower rate of uterine rupture (0% vs. 0.3%, P = 0.045) with LUST and EFW measurements. CONCLUSION: Third-trimester ultrasound with EFW and LUST measurement is associated with a significant reduction in major perinatal morbidity in women with a prior cesarean delivery.

Impact of Gestational Weight Gain Recommendations for Obese Women on Neonatal Morbidity.

INTRODUCTION: In 2013, the American College of Obstetricians and Gynecologists (ACOGs) developed gestational weight gain guidelines to minimize the risks associated with obesity during pregnancy. However, a growing body of evidence suggests that current recommendations should be revised for obese women. OBJECTIVES: The objective of this study is to assess the impact of gestational weight gain recommendations for obese women (body mass index ≥ 30 kg/m2) on neonatal and maternal outcomes in Quebec. STUDY DESIGN: Secondary analysis of the QUARISMA trial was performed including obese women who delivered a full-term singleton in cephalic presentation from 2008 to 2011 in Quebec. Outcomes assessed were composite risks of major neonatal and maternal complications, minor neonatal and maternal complications, as well as obstetrical interventions. Outcomes were compared between weight gain recommendations (reference group) and three weight gain/loss categories using logistic regressions. In second analysis, obese women were stratified by obesity class. RESULTS: Among the 16,808 eligible obese women, 605 lost weight during pregnancy, 2,665 gained between 0 and 4.9 kg, 4,355 gained weight within the recommendations (5-9.09 kg), and 9,183 gained at least 9.1 kg. Results showed a significant reduction in major neonatal morbidity (adjusted odds ratio [aOR] = 0.69, 95% confidence interval [CI] = 0.51-0.94), minor maternal morbidity (aOR = 0.79, 95%CI = 0.67-0.93), and assisted vaginal delivery (aOR = 0.82, 95%CI = 0.68-0.99) among women who gained 0 to 4.9 kg compared with the reference group. Cesarean delivery and preeclampsia/eclampsia were significantly reduced with weight loss (aOR = 0.76, 95%CI = 0.64-0.89 and 0.58, 95%CI = 0.42-0.78) compared with the reference group. Weight gain above recommendations was associated with an increased risk of minor neonatal morbidity, major and minor maternal morbidity, as well as cesarean delivery. CONCLUSIONS: Compared with a weight gain within the recommendations, a gestational weight gain/loss of less than 5 kg in obese women is associated with a reduced risk of major neonatal morbidity, minor maternal morbidity, preeclampsia/eclampsia, cesarean delivery, and assisted vaginal delivery. Guidelines on gestational weight gain for obese women should be updated. KEY POINTS: · Gestational weight gain/loss of less than 5 kg reduces the risk of perinatal complications.. · As suggested by ACOG recommendations, guidelines for obese women should be updated.. · Recommendations stratified by obesity class should be included in revised guidelines..

Group transdiagnostic cognitive-behavior therapy for anxiety disorders: a pragmatic randomized clinical trial.

BACKGROUND: Transdiagnostic group cognitive-behavioral therapy (tCBT) is a delivery model that could help overcome barriers to large-scale implementation of evidence-based psychotherapy for anxiety disorders. The aim of this study was to assess the effectiveness of combining group tCBT with treatment-as-usual (TAU), compared to TAU, for the treatment of anxiety disorders in community-based mental health care. METHODS: In a multicenter single-blind, two-arm pragmatic superiority randomized trial, we recruited participants aged 18-65 who met DSM-5 criteria for principal diagnoses of generalized anxiety disorder, social anxiety disorder, panic disorder, or agoraphobia. Group tCBT consisted of 12 weekly 2 h sessions. There were no restrictions for TAU. The primary outcome measures were the Beck Anxiety Inventory (BAI) and clinician severity rating from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) for the principal anxiety disorder at post-treatment, with intention-to-treat analysis. RESULTS: A total of 231 participants were randomized to either tCBT + TAU (117) or TAU (114), with outcome data available for, respectively, 95 and 106. Results of the mixed-effects regression models showed superior improvement at post-treatment for participants in tCBT + TAU, compared to TAU, for BAI [p < 0.001; unadjusted post-treatment mean (s.d.): 13.20 (9.13) v. 20.85 (10.96), Cohen's d = 0.76] and ADIS-5 [p < 0.001; 3.27 (2.19) v. 4.93 (2.00), Cohen's d = 0.79]. CONCLUSIONS: Our findings suggest that the addition of group tCBT into usual care can reduce symptom severity in patients with anxiety disorders, and support tCBT dissemination in routine community-based care.

DECIDE: a cluster-randomized controlled trial to reduce unnecessary caesarean deliveries in Burkina Faso.

BACKGROUND: In Burkina Faso, facility-based caesarean delivery rates have markedly increased since the national subsidy policy for deliveries and emergency obstetric care was implemented in 2006. Effective and safe strategies are needed to prevent unnecessary caesarean deliveries. METHODS: We conducted a cluster-randomized controlled trial of a multifaceted intervention at 22 referral hospitals in Burkina Faso. The evidence-based intervention was designed to promote the use of clinical algorithms for caesarean decision-making using in-site training, audits and feedback of caesarean indications and SMS reminders. The primary outcome was the change in the percentage of unnecessary caesarean deliveries. Unnecessary caesareans were defined on the basis of the literature review and expert consensus. Data were collected daily using a standardized questionnaire, in the same way at both the intervention and control hospitals. Caesareans were classified as necessary or unnecessary in the same way, in both arms of the trial using a standardized computer algorithm. RESULTS: A total of 2138 and 2036 women who delivered by caesarean section were analysed in the pre and post-intervention periods, respectively. A significant reduction in the percentage of unnecessary caesarean deliveries was evident from the pre- to post-intervention period in the intervention group compared with the control group (18.96 to 6.56% and 18.27 to 23.30% in the intervention and control groups, respectively; odds ratio [OR] for incremental change over time, adjusted for hospital and patient characteristics, 0.22; 95% confidence interval [CI], 0.14 to 0.34; P < 0.001; adjusted risk difference, - 17.02%; 95% CI, - 19.20 to - 13.20%). The intervention did not significantly affect the rate of maternal death (0.75 to 0.19% and 0.92 to 0.40% in the intervention and control groups, respectively; adjusted OR 0.32; 95% CI 0.04 to 2.23; P = 0.253) or intrapartum-related neonatal death (4.95 to 6.32% and 5.80 to 4.29% in the intervention and control groups, respectively, adjusted OR 1.73; 95% CI 0.82 to 3.66; P = 0.149). The overall perinatal mortality data were not available. CONCLUSION: Promotion and training on clinical algorithms for decision-making, audit and feedback and SMS reminders reduced unnecessary caesarean deliveries, compared with usual care in a low-resource setting. TRIAL REGISTRATION: The DECIDE trial is registered on the Current Controlled Trials website: ISRCTN48510263 .

Impact of Audits and Multifaceted Intervention on Vaginal Birth After Caesarean: Secondary Analysis of the QUARISMA Trial.

OBJECTIVES: This study estimated the effect that a multifaceted intervention aiming to improve the quality of obstetrical care and reduce Caesarean section (CS) had on the rate of vaginal birth after Caesarean (VBAC). METHODS: This is a secondary analysis of the cluster randomized controlled trial Quality of Care, Obstetrics Risk Management, and Mode of Delivery involving (1) audits regarding the indications for CS, (2) provision of feedback to health professionals, and (3) implementation of best practices to reduce CS rates in Quebec. The impact of intervention on VBAC, trial of labour (TOL), and maternal and neonatal morbidity was reported using adjusted odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Out of 105 351 women who delivered during the pre- and postintervention period, 12 493 (11.9%) had a previous CS. We observed no significant impact of the multifaceted intervention on the rates of TOL (adjusted OR 1.22; 95% CI 0.96-1.56, P = 0.11) and VBAC (adjusted OR 1.20; 95% CI 0.97-1.48, P = 0.10) in women with one previous CS. However, the rate of TOL was reduced (adjusted OR 0.38; 95% CI 0.14-0.99) in women with more than one previous CS. The intervention has no influence on maternal and neonatal morbidity. CONCLUSIONS: A multifaceted intervention including audits, feedback to health professionals, and implementation of best practices did not affect VBAC rates or maternal and neonatal morbidity. Our results pointed out the need for decision-making processand risk management tools specific to women with previous CS.

A cluster-randomized trial to reduce cesarean delivery rates in Quebec.

BACKGROUND: In Canada, cesarean delivery rates have increased substantially over the past decade. Effective, safe strategies are needed to reduce these rates. METHODS: We conducted a cluster-randomized, controlled trial of a multifaceted 1.5-year intervention at 32 hospitals in Quebec. The intervention involved audits of indications for cesarean delivery, provision of feedback to health professionals, and implementation of best practices. The primary outcome was the cesarean delivery rate in the 1-year postintervention period. RESULTS: Among the 184,952 participants, 53,086 women delivered in the year before the intervention and 52,265 women delivered in the year following the intervention. There was a significant but small reduction in the rate of cesarean delivery from the preintervention period to the postintervention period in the intervention group as compared with the control group (change, 22.5% to 21.8% in the intervention group and 23.2% to 23.5% in the control group; odds ratio for incremental change over time, adjusted for hospital and patient characteristics, 0.90; 95% confidence interval [CI], 0.80 to 0.99; P=0.04; adjusted risk difference, -1.8%; 95% CI, -3.8 to -0.2). The cesarean delivery rate was significantly reduced among women with low-risk pregnancies (adjusted risk difference, -1.7%; 95% CI, -3.0 to -0.3; P=0.03) but not among those with high-risk pregnancies (P=0.35; P = 0.03 for interaction). The intervention group also had a reduction in major neonatal morbidity as compared with the control group (adjusted risk difference, -0.7%; 95% CI, -1.3 to -0.1; P=0.03) and a smaller increase in minor neonatal morbidity (adjusted risk difference, -1.7%; 95% CI, -2.6 to -0.9; P<0.001). Changes in minor and major maternal morbidity did not differ significantly between the groups. CONCLUSIONS: Audits of indications for cesarean delivery, feedback for health professionals, and implementation of best practices, as compared with usual care, resulted in a significant but small reduction in the rate of cesarean delivery, without adverse effects on maternal or neonatal outcomes. The benefit was driven by the effect of the intervention in low-risk pregnancies. (Funded by the Canadian Institutes of Health Research; QUARISMA Current Controlled Trials number, ISRCTN95086407.).

A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol.

BACKGROUND: Anxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. While cognitive behaviour therapy (CBT) is the most consistently efficacious psychological treatment for anxiety disorders, barriers preclude widespread implementation of CBT in primary care. Transdiagnostic group CBT (tCBT) focuses on cognitive and behavioural processes and intervention strategies common to different anxiety disorders, and could be a promising alternative to conventional CBT. This study aims to examine the effectiveness of a transdiagnostic group CBT for anxiety disorders program as a complement to treatment-as-usual (TAU) in primary mental health care. METHODS/DESIGN: The trial is a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment, and follow-up at 4, 8 and 12-months design. Treatment and control groups. a) tCBT (12 weekly 2-h group sessions following a manualized treatment protocol); b) TAU for anxiety disorders. Inclusion criteria comprise meeting DSM-5 criteria for primary Panic Disorder, Agoraphobia, Social Anxiety Disorder and/or Generalized Anxiety Disorder. Patients are recruited in three regions in the province of Quebec, Canada. The primary outcome measures are the self-reported Beck Anxiety Inventory and the clinician-administered Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5); secondary outcome measures include treatment responder status based on the ADIS-5, and self-reported instruments for specific anxiety and depression symptoms, quality of life, functioning, and service utilisation. STATISTICAL ANALYSIS: Intention-to-treat analysis. A mixed effects regression model will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of the intervention. DISCUSSION: This rigorous evaluation of tCBT in the real world will provide invaluable information to decision makers, health care managers, clinicians and patients regarding the effectiveness of the intervention. Widespread implementation of tCBT protocols in primary care could lead to better effectiveness, efficiency, access and equity for the large number of patients suffering from anxiety disorders that are currently not obtaining evidence-based psychotherapy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02811458 .

No. 355-Physiologic Basis of Pain in Labour and Delivery: An Evidence-Based Approach to its Management.

OBJECTIVE: To review the evidence relating to nonpharmacological approaches in the management of pain during labour and delivery. To formulate recommendations for the usage of nonpharmacological approaches to pain management. OPTIONS: Nonpharmacological methods available for pain management during labour and delivery exist. These should be included in the counselling and care of women. EVIDENCE: PubMed and Medline were searched for articles in French and English on subjects related to "breastfeeding," "pain," "epidural," "anaesthesia," "analgesia," "labour," "labor," and combined with "gate control theory," "alternative therapies," "massage," "position," "mobility," "TENS," "bathing," "DNIC," "acupuncture," "acupressure," "sterile water injection," "higher center," "control mind," "cognitive structuring," "holistic health," "complementary therapy(ies)," "breathing," "relaxation," "mental imagery," "visualization," "mind focusing," "hypnosis," "auto-hypnosis," "sophrology," "mind and body interventions," "music," "odors," "biofeedback," "Lamaze," "Bonapace," "prenatal training," "gymnastic," "chanting," "haptonomy," "environment," "transcutaneous electrical stimulus-stimulation," "antenatal education," "support," "continuous support," "psychosocial support," "psychosomatic medicine," "supportive care," "companion," "intrapartum care," "nurse," "midwife(ves)," "father," "doula," "caregiver," " hormones," "oxytocin," "endorphin," "prolactin," "catecholamine," "adrenaline," and "noradrenaline" from 1990 to December 2015. Additional studies were identified by screening reference lists from selected studies and from expert suggestions. No language restrictions were applied. VALIDATION METHODS: The quality of the evidence is rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care. Recommendations for practice are ranked according to the method described in this report. BENEFITS, RISKS, AND COST: The nonpharmacological method encourages an incremental approach to pain management that contributes to reduced interventions through optimal use of the woman's neurophysiologic and endocrine resources and a better understanding of the physiology of stress and pain during labour. GUIDELINE UPDATE: The guideline will be reviewed 5 years after publication to decide whether all of part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycles, the review process may be accelerated for a more rapid update of some recommendations. SPONSORS: This guideline was developed with resources funded by The Society of Obstetricians and Gynaecologists of Canada. SUMMARY STATEMENTS: RECOMMENDATIONS.

Impacts of online and group perinatal education: a mixed methods study protocol for the optimization of perinatal health services.

BACKGROUND: Prenatal education is a core component of perinatal care and services provided by health institutions. Whereas group prenatal education is the most common educational model, some health institutions have opted to implement online prenatal education to address accessibility issues as well as the evolving needs of future parents. Various studies have shown that prenatal education can be effective in acquisition of knowledge on labour and delivery, reducing psychological distress and maximising father's involvement. However, these results may depend on educational material, organization, format and content. Furthermore, the effectiveness of online prenatal education compared to group prenatal education remains unclear in the literature. This project aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and users' health status, as well as on networks of perinatal educational services maintained with community-based partners. METHODS: This multipronged mixed methods study uses a collaborative research approach to integrate and mobilize knowledge throughout the process. It consists of: 1) a prospective cohort study with quantitative data collection and qualitative interviews with future and new parents; and 2) a multiple case study integrating documentary sources and interviews with stakeholders involved in the implementation of perinatal information service networks and collaborations with community partners. Perinatal health indicators and determinants will be compared between prenatal education groups (group prenatal education and online prenatal education) and standard care without these prenatal education services (control group). DISCUSSION: This study will provide knowledge about the impact of online prenatal education as a new technological service delivery model compared to traditional group prenatal education. Indicators related to the complementarity of these interventions and those available in community settings will refine our understanding of regional perinatal services networks. Results will assist decision-making regarding service organization and delivery models of prenatal education services. PROTOCOL VERSION: Version 1 (February 9 2018).

A cluster-randomized trial to reduce caesarean delivery rates in Quebec: cost-effectiveness analysis.

BACKGROUND: Widespread increases in caesarean section (CS) rates have sparked concerns about risks to mothers and infants and rising healthcare costs. A multicentre, two-arm, cluster-randomized trial in Quebec, Canada assessed whether an audit and feedback intervention targeting health professionals would reduce CS rates for pregnant women compared to usual care, and concluded that it reduced CS rates without adverse effects on maternal or neonatal health. The effect was statistically significant but clinically small. We assessed cost-effectiveness to inform scale-up decisions. METHODS: A prospective economic evaluation was undertaken using individual patient data from the Quality of Care, Obstetrics Risk Management, and Mode of Delivery (QUARISMA) trial (April 2008 to October 2011). Analyses took a healthcare payer perspective. The time horizon captured hospital-based costs and clinical events for mothers and neonates from labour onset to 3 months postpartum. Resource use was identified and measured from patient charts and valued using standardized government sources. We estimated the changes in CS rates and costs for the intervention group (versus controls) between the baseline and post-intervention periods. We examined heterogeneity between clinical subgroups of high-risk versus low-risk pregnancies and estimated the joint uncertainty in cost-effectiveness over 20,000 trial simulations. We decomposed costs to identify drivers of change. RESULTS: The intervention group experienced per-patient reductions of 0.005 CS (95% confidence interval (CI): -0.015 to 0.004, P = 0.09) and $180 (95% CI: -$277 to - $83, P < 0.001). Women with low-risk pregnancies experienced statistically significant reductions in CS rates and costs; changes for the high-risk subgroup were not significant. The intervention was "dominant" (effective in reducing CS and less costly than usual care) in 86.08% of simulations. It reduced costs in 99.99% of simulations. Cost reductions were driven by lower rates of neonatal complications in the intervention group (-$190, 95% CI: -$255 to - $125, P < 0.001). Given 88,000 annual provincial births, a similar intervention could save $15.8 million (range: $7.3 to $24.4 million) in Quebec annually. CONCLUSIONS: From a healthcare payer perspective, a multifaceted intervention involving audits and feedback resulted in a small reduction in caesarean deliveries and important cost savings. Cost reductions are consistent with improved quality of care in intervention group hospitals. TRIAL REGISTRATION: International Clinical Trials Registry Platform, ISRCTN95086407 . Registered on 23 October 2007.

The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis.

BACKGROUND: Preeclampsia and fetal growth restriction are major causes of perinatal death and handicap in survivors. Randomized clinical trials have reported that the risk of preeclampsia, severe preeclampsia, and fetal growth restriction can be reduced by the prophylactic use of aspirin in high-risk women, but the appropriate dose of the drug to achieve this objective is not certain. OBJECTIVE: We sought to estimate the impact of aspirin dosage on the prevention of preeclampsia, severe preeclampsia, and fetal growth restriction. STUDY DESIGN: We performed a systematic review and meta-analysis of randomized controlled trials comparing the effect of daily aspirin or placebo (or no treatment) during pregnancy. We searched MEDLINE, Embase, Web of Science, and Cochrane Central Register of Controlled Trials up to December 2015, and study bibliographies were reviewed. Authors were contacted to obtain additional data when needed. Relative risks for preeclampsia, severe preeclampsia, and fetal growth restriction were calculated with 95% confidence intervals using random-effect models. Dose-response effect was evaluated using meta-regression and reported as adjusted R2. Analyses were stratified according to gestational age at initiation of aspirin (≤16 and >16 weeks) and repeated after exclusion of studies at high risk of biases. RESULTS: In all, 45 randomized controlled trials included a total of 20,909 pregnant women randomized to between 50-150 mg of aspirin daily. When aspirin was initiated at ≤16 weeks, there was a significant reduction and a dose-response effect for the prevention of preeclampsia (relative risk, 0.57; 95% confidence interval, 0.43-0.75; P < .001; R2, 44%; P = .036), severe preeclampsia (relative risk, 0.47; 95% confidence interval, 0.26-0.83; P = .009; R2, 100%; P = .008), and fetal growth restriction (relative risk, 0.56; 95% confidence interval, 0.44-0.70; P < .001; R2, 100%; P = .044) with higher dosages of aspirin being associated with greater reduction of the 3 outcomes. Similar results were observed after the exclusion of studies at high risk of biases. When aspirin was initiated at >16 weeks, there was a smaller reduction of preeclampsia (relative risk, 0.81; 95% confidence interval, 0.66-0.99; P = .04) without relationship with aspirin dosage (R2, 0%; P = .941). Aspirin initiated at >16 weeks was not associated with a risk reduction or a dose-response effect for severe preeclampsia (relative risk, 0.85; 95% confidence interval, 0.64-1.14; P = .28; R2, 0%; P = .838) and fetal growth restriction (relative risk, 0.95; 95% confidence interval, 0.86-1.05; P = .34; R2, not available; P = .563). CONCLUSION: Prevention of preeclampsia and fetal growth restriction using aspirin in early pregnancy is associated with a dose-response effect. Low-dose aspirin initiated at >16 weeks' gestation has a modest or no impact on the risk of preeclampsia, severe preeclampsia, and fetal growth restriction. Women at high risk for those outcomes should be identified in early pregnancy.

Single versus double-layer uterine closure at cesarean: impact on lower uterine segment thickness at next pregnancy.

BACKGROUND: Uterine rupture is a potential life-threatening complication during a trial of labor after cesarean delivery. Single-layer closure of the uterus at cesarean delivery has been associated with an increased risk of uterine rupture compared with double-layer closure. Lower uterine segment thickness measurement by ultrasound has been used to evaluate the quality of the uterine scar after cesarean delivery and is associated with the risk of uterine rupture. OBJECTIVE: To estimate the impact of previous uterine closure on lower uterine segment thickness. STUDY DESIGN: Women with a previous single low-transverse cesarean delivery were recruited at 34-38 weeks' gestation. Transabdominal and transvaginal ultrasound evaluation of the lower uterine segment thickness was performed by a sonographer blinded to clinical data. Previous operative reports were reviewed to obtain the type of previous uterine closure. Third-trimester lower uterine segment thickness at the next pregnancy was compared according to the number of layers sutured and according to the type of thread for uterine closure, using weighted mean differences and multivariate logistic regression analyses. RESULTS: Of 1613 women recruited, with operative reports available, 495 (31%) had a single-layer and 1118 (69%) had a double-layer closure. The mean third-trimester lower uterine segment thickness was 3.3 ± 1.3 mm and the proportion with lower uterine segment thickness <2.0 mm was 10.5%. Double-layer closure of the uterus was associated with a thicker lower uterine segment than single-layer closure (weighted mean difference: 0.11 mm; 95% confidence interval [CI], 0.02 to 0.21 mm). In multivariate logistic regression analyses, a double-layer closure also was associated with a reduced risk of lower uterine segment thickness <2.0 mm (odd ratio [OR], 0.68; 95% CI, 0.51 to 0.90). Compared with synthetic thread, the use of catgut for uterine closure had no significant impact on third-trimester lower uterine segment thickness (WMD: -0.10 mm; 95% CI, -0.22 to 0.02 mm) or on the risk of lower uterine segment thickness <2.0 mm (OR, 0.95; 95% CI, 0.67 to 1.33). Finally, double-layer closure was associated with a reduced risk of uterine scar defect (RR, 0.32; 95% CI, 0.17 to 0.61) at birth. CONCLUSION: Compared with single-layer closure, a double-layer closure of the uterus at previous cesarean delivery is associated with a thicker third-trimester lower uterine segment and a reduced risk of lower uterine segment thickness <2.0 mm in the next pregnancy. The type of thread for uterine closure has no significant impact on lower uterine segment thickness.

Reporting Caesarean Delivery in Quebec Using the Robson Classification System.

OBJECTIVE: The increasing rates of Caesarean sections throughout the world is preoccupant, and a good understanding of which groups of women contribute the most to the CS rate represents an important question in public health. Therefore, we sought to report the CS rate according to the Robson's classification system in the Quebec population. METHOD: We performed a secondary analysis of the QUARISMA database, including all deliveries after 24 weeks' gestation from 32 maternity wards in the province of Quebec between 2008 and 2011 (n = 184 952 deliveries). CS rates were reported according to the modified Robson criteria from The Society of Obstetricians and Gynaecologists of Canada with the relative contribution to the total number of CSs. RESULTS: We observed a global CS rate of 22.9%. Women with previous CS and a fetus in cephalic presentation at term accounted for 35% of all Caesarean deliveries. Nulliparous women with cephalic presentation at term accounted for 30% of all CSs. Among nulliparous women with cephalic presentation, women with spontaneous labour contributed to 12% of all CSs, whereas women with an induction of labour contributed to 16% of all CSs. Non-cephalic fetal presentation accounted for 19% of all CSs. Other indications accounted for the remaining 16% of CSs. CONCLUSION: Most CSs are performed for multiparous women with previous CS; nulliparous women with a cephalic presentation at term, especially those undergoing labour induction; and non-cephalic fetal presentation.

Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial.

BACKGROUND: Incomplete healing of uterine scar after cesarean has been associated with adverse gynecological and obstetrical outcomes. Several studies reported that uterine closure at cesarean influences the healing of uterine scar and the risk of uterine rupture at subsequent pregnancies: the commonly used locked single-layer suture including the decidua being associated with a 4-fold increased risk of uterine rupture. However, data from randomized trials are lacking. OBJECTIVE: We sought to evaluate the impact of 3 techniques of uterine closure after cesarean delivery on uterine scar healing. STUDY DESIGN: This was a 3-arm 1:1:1 randomized study in women with singleton pregnancies undergoing elective primary cesarean delivery at ≥38 weeks' gestation. Closure of the uterine scar was carried out by locked single layer including the decidua, double layer with locked first layer including the decidua, or double layer with unlocked first layer excluding the decidua. Primary outcome was residual myometrial thickness (RMT) at the site of the scar, measured by transvaginal ultrasound 6 months after delivery. Secondary outcome was the RMT as a percentage of the myometrial thickness above the scar (healing ratio). Intent-to-treat analyses using Student t test were performed to compare each double-layer technique to the single-layer closure, and P < .025 was considered significant. RESULTS: Complete follow-up was obtained from 73 (90%) of the 81 participants. Compared to single-layer closure, double-layer closure with unlocked first layer was associated with thicker RMT (3.8 ± 1.6 mm vs 6.1 ± 2.2 mm; P < .001) and greater healing ratio (54 ± 20% vs 73 ± 23%; P = .004). In contrast, double-layer closure with locked first layer was not significantly different than single-layer closure in either RMT (4.8 ± 1.3; P = .032) or healing ratio (60 ± 21%; P = .287). CONCLUSION: Double-layer closure with unlocked first layer is associated with better uterine scar healing than locked single layer.

Lower uterine segment thickness to prevent uterine rupture and adverse perinatal outcomes: a multicenter prospective study.

BACKGROUND: Choice of delivery route after previous cesarean delivery can be difficult because both trial of labor after cesarean delivery and elective repeat cesarean delivery are associated with risks. The major risk that is associated with trial of labor after cesarean delivery is uterine rupture that requires emergency laparotomy. OBJECTIVE: This study aimed to estimate the occurrence of uterine rupture during trial of labor after cesarean delivery when lower uterine segment thickness measurement is included in the decision-making process about the route of delivery. STUDY DESIGN: In 4 tertiary-care centers, we prospectively recruited women between 34 and 38 weeks of gestation who were contemplating a vaginal birth after a previous single low-transverse cesarean delivery. Lower uterine segment thickness was measured by ultrasound imaging and integrated in the decision of delivery route. According to lower uterine segment thickness, women were classified in 3 risk categories for uterine rupture: high risk (<2.0 mm), intermediate risk (2.0-2.4 mm), and low risk (≥2.5 mm). Our primary outcome was symptomatic uterine rupture, which was defined as requiring urgent laparotomy. We calculated that 942 women who were undergoing a trial of labor after cesarean delivery should be included to be able to show a risk of uterine rupture <0.8%. RESULTS: We recruited 1856 women, of whom 1849 (99%) had a complete follow-up data. Lower uterine segment thickness was <2.0 mm in 194 women (11%), 2.0-2.4 mm in 217 women (12%), and ≥2.5 mm in 1438 women (78%). Rate of trial of labor was 9%, 42%, and 61% in the 3 categories, respectively (P<.0001). Of 984 trials of labor, there were no symptomatic uterine ruptures, which is a rate that was lower than the 0.8% expected rate (P=.0001). CONCLUSION: The inclusion of lower uterine segment thickness measurement in the decision of the route of delivery allows a low risk of uterine rupture during trial of labor after cesarean delivery.

Labor Dystocia and the Risk of Uterine Rupture in Women with Prior Cesarean.

Objective The objective of this study was to evaluate the association between labor dystocia and uterine rupture. Methods We performed a secondary analysis of a multicenter case-control study that included women with single, prior, low-transverse cesarean section who experienced complete uterine rupture during a trial of labor (TOL). For each case, three women who underwent a TOL without uterine rupture were selected as controls. Data were collected on cervical dilatations from admission to delivery. We evaluated the relationship between uterine rupture and labor dystocia according to several criteria, including the World Health Organization's (WHO's) partogram. Results Data were available for 90 cases and 260 controls. Compared with the controls, uterine rupture was associated with less cervical dilatation on admission, slower cervical dilatation in the first stage of labor and longer second stage of labor (all with p < 0.05). Performing cesarean when the labor curve crossed the ACTION line of WHO's partogram or when the second stage was greater than 2 hours could have (1) prevented up to 56% of uterine rupture and (2) reduced the duration of labor in 57% of women with failed TOL. Conclusion Labor dystocia is a significant risk factor for uterine rupture. Labor progression should be assessed regularly in women with prior cesarean.