Background The coronavirus disease 2019 (COVID-19) pandemic has given rise to the need to develop a vaccine as quickly as possible. As pregnant women are at increased risk of contracting severe COVID-19, with higher mortality, it is essential to assess the safety of the vaccines administered during pregnancy. Methods The aim of this study was to determine the titer of specific maternal and cord antibodies against severe acute respiratory syndrome coronavirus 2 S protein after antenatal vaccination. The secondary objective was to evaluate the ratio of the umbilical cord to the maternal antibody titers. Patients included in the study were enrolled after undergoing voluntary vaccination against COVID-19 during pregnancy at different weeks of gestation. Their decision concerning vaccination was independent of the decision to participate in the present study. All patients analyzed in our initial study were vaccinated with the BNT162b2 mRNA COVID-19 vaccine. Results The results of the current study document high anti-S total antibody titers in cord serum at birth in all mother-infant pairs analyzed. Conclusions Our study suggests that maternal immunization may provide neonatal protection through transplacental transfer of antibodies.

Objective: To study complications, within six weeks postpartum, after planned caesarean section (CS) compared with planned vaginal delivery, among women without formal indication for caesarean section. Design: Retrospective cohort study. Setting: Swedish national registries. Population: 714 326 deliveries, 2008-2017. Methods: The risks of complications were compared between planned caesarean section and planned vaginal delivery among women without formal medical indication for planned CS. Adjusted Risk Ratios (ARR) were obtained using modified Poisson-regression models adjusting for; maternal age, parity, body mass index, smoking, country of birth, and county. Main outcome measure: infections, haemorrhage and thromboembolism. Results:. In the planned CS group (n=22 855), 15% had a postpartum infection compared with 10% in the planned vaginal group (n=691 471) (ARR=1.6; 95%CI 1.5-1.6), 8.4% vs 0.6% had haemorrhage >1 litre (ARR=13.4; 95%CI 12.7-14.2), and 0.08% vs 0.05% had a postpartum pulmonary embolism (ARR=1.7; 95%CI 1.0-2.6). The obtained risk estimates correspond to a Number-Needed-to-Harm estimate of 17, 14, and 3448, respectively. When dividing the infections into subgroups, an increased risk of endometritis (ARR 1.2; 95%CI 1.1-1.3), wound infection (ARR 2.7 95%CI 2.4-3.0), urinary tract infections (ARR 1.5 95%CI 1.3-1.7), and mastitis (ARR 2.0; 1.9-2.2) was found after planned CS. Conclusion: The risks of short-term maternal complications were higher in women delivered by planned CS compared with planned vaginal delivery among women without formal medical indication for planned CS. Funding: Gorthon Foundation. Key words: caesarean section, puerperal infection, haemorrhage, thromboembolism.

Purpose: The aim of a color coded protocol for non-elective cesarean-sections is to improve decision-delivery interval by better organization of care in a maternity unit. We set out to assess compliance of a color coded protocol and its impact on maternal and neonatal outcomes since its implementation in our maternity ward. Materials and methods: This was a retrospective study including a sample of 200 patients per year who underwent an non-elective cesarean section delivery in Rennes University Hospital from January 1, 2015 to December 31, 2018. Patients were grouped by year and by color code (red, orange or green). The main outcome was compliance with the protocol (color code in accordance with indication for cesarean section) and compliance with the corresponding decision-delivery interval. Secondary outcomes were maternal and neonatal outcomes. The statistical tests performed were Fisher’s test for qualitative parameters and Kruskal-Wallis test for quantitative parameters. Results: Eight hundred patients were included during the study period. There was no significant difference in patient characteristics over the years. There was a significant improvement in protocol compliance: full compliance increased from 22.4% in 2015 to 76.5% in 2018 (p<0.0001). No difference was observed in the decision-delivery interval overall but compliance with the 15-minute decision-delivery interval imposed by a red coded protocol increased between 2015 and 2018 (p=0.0020). Conclusion: We observed a significant improvement in compliance with the color coded protocol between 2015 and 2018 and in the 15-minute decision-delivery deadline for the red code.

Mini Commentary – BJOG

Anaemia in pregnancy remains a global health problem In this issue of BJOG Hull et al …… et al report on an important study from South Africa regarding anaemia in pregnancy and the response to iron therapy. They report that in HIV-positive women the response was slower than in HIV-negative women. The underlying causes of anaemia varied and included iron deficiency (as assessed by ferritin levels) as well as concurrent infections (urinary tract infections and tuberculosis)Anaemia in pregnancy (blood haemoglobin Hb<11.0g/dl) occurs in > 40% of women living in low- and middle-income countries (LMIC) and in some settings in Asia prevalence is >60%. (McCauley et al, BMJ Global Health, 2018; 3(3):e000625) The latest WHO recommendations on antenatal care consider anaemia as the world’s second leading cause of disability and one of the most serious global public health problems (WHO Geneva 2016 ) .Although globally the focus has largely been on anaemia in pregnancy resulting from either iron deficiency or malaria, this is an incomplete approach at best. Iron deficiency is hard to measure and confirm as; i) this requires a functioning laboratory to be in place, ii) indicators for iron deficiency are influenced by the presence of concurrent infection, or, iii) repeated measures of Hb are needed to check whether the anaemia is responsive to treatment with iron. By contrast, malaria is relatively easy to diagnose via rapid diagnostic tests or microscopic examination of a stained blood smear slide. The handful of studies which have comprehensively assessed aetiology of anaemia in pregnant women demonstrate that anaemia is most commonly the result of complex multiple underlying factors including nutritional deficiencies as well as infectious diseases. Both nutritional deficiency and other infections (malaria, tuberculosis) are more likely with HIV-infection which itself can lead to anaemia probably through direct suppression of erythropoiesis.Hull et al show what was possible in a real-life clinical practice setting. This example of integration of research into clinical practice is laudable and is illustrative of how such integration could result in better services being made available for women in LMIC where burden of disease is high, but diagnostic tests are largely unavailable. It is sobering to realise that the majority of women world-wide will still only be screened for anaemia during pregnancy using ‘conjunctival inspection’ which is highly inaccurate. (van den Broek et al. Bull WHO 1999; 77(1):15-21) Rapid diagnostic tests are available for Hb, malaria, syphilis, HIV and, more recently, for tuberculosis. We are doing women a dis-service if we cannot offer at least these basic diagnostic tests as part of antenatal care.To prevent anaemia during pregnancy, the ‘fall-back’ position is to offer all women daily iron prophylaxis (30-60mg elemental iron) - with luck tablets are available that include folic acid (0.4mg) - along with presumptive treatment of malaria (various regimes) in endemic areas. Multi-micronutrients (including the required amount of iron and folic acid) might actually be better but cannot be recommended because of lack of evidence and they are still three times as expensive as iron and folic acid supplementation alone (3$ vs 1$ approximately).WHO recently recommended a better understanding of the aetiology of anaemia. A search on PubMed shows a clear lack of papers on the topic and more good research is needed. Investment in the antenatal care package offered to women is also much needed if we are aiming for a global ‘Health for All’.

Objective: To develop the prediction models for identifying fetal occiput rotation and vaginal delivery based on intrapartum sonographic findings. Design: Prospective observational study. Setting: Hangzhou, China. Population: Nulliparous women with a singleton cephalic presentation at term. Methods: Serial intrapartum ultrasonography were performed in the latent phase (T1) and every three hours after that (T2, T3 and T4). The managing clinicians performed paired digital vaginal examinations to assess labor progress. Main Outcome Measures: Delivery mode and successful internal fetal head rotation to the occiput anterior (OA) position. Results: 614 women were included, of whom 524 underwent vaginal delivery, and 90 required cesarean section. The percentage of women with fetuses in non-occiput anterior position at the latent phase was 53.9% (331 cases), as 257 women underwent spontaneous rotation to OA position before delivery, 74 were with persistent occiput posterior or transverse position. We developed a model on the basis of the maternal height and middle angel to predict the spontaneous fetal occiput rotation, with the area under the receiver operating characteristic curve (AUC) was 0.667 (95%CI 0.583-0.751). Moreover, a prediction model based on the maternal height and angle of progression to evaluate whether women underwent vaginal delivery was also developed, of which the AUC was 0.738(95% CI: 0.763-0.793). Both models showed satisfactory calibration. Conclusion: Simple models based on maternal characteristics and intrapartum ultrasound findings might provide useful information for predicting vaginal delivery and internal fetal occiput rotation.

Objective: To validate the Weiniger model, a multivariable prediction model for placenta accreta spectrum (PAS). Design: Multicentre external validation study. Setting: Two tertiary care hospitals in the United States. Population: Cohort A included patients with risk factors (prior caesarean delivery, placenta praevia) and/or ultrasound features of PAS (variable risk) presenting to a tertiary care hospital. Cohort B patients were referred to a tertiary care hospital specifically for ultrasound features of PAS (higher risk). Methods: Weiniger model variables (prior caesarean deliveries, placenta praevia and ultrasound features of PAS) were retrospectively collected from both cohorts and predictive performance of the model was evaluated. Main Outcome Measures: Surgical and/or pathological diagnosis of PAS. Results: The model c-statistic in cohorts A and B was 0.728 (95% CI: 0.662, 0.794) and 0.866 (95% CI: 0.754, 0.977) signifying acceptable and excellent discrimination, respectively. Based on calibration curves, the model underestimated average PAS risk in both cohorts. In both cohorts, high risk was overestimated and low risk underestimated. Use of this model compared to a “treat all” strategy had greater net benefit at a threshold probability of > 0.25 in cohort A, but no net benefit in cohort B. Conclusions: This study provides multicentre external validation of the Weiniger model for PAS prediction, making it a useful triaging tool for management of this high-risk obstetric condition. Clinical usefulness of this model is influenced by the incidence of risk factors and PAS ultrasound features, with better performance in a variable-risk population at threshold probability >25%.

Episiotomy and operative vaginal delivery- Do we need more evidence?A.H. Sultan- Urogynaecology and Pelvic Floor Reconstruction Unit, Croydon University Hospital, London Road, Croydon CR7 7YE- Honorary Reader, St George’s University of LondonEmail:asultan29@gmail.comTel: 00 44 7961386840(ORCID 0000-0001-8979-2304)J.W. de Leeuw, Department of Obstetrics and Gynaecology, Ikazia Ziekenhuis, Rotterdam, the Netherlands(ORCID 0000-0001-5028-8055)DISCLOSURE of INTERESTAbdul Sultan is the co-director of the Croydon Perineal and Anal Sphincter Trauma courses (www.perineum.net)Operative vaginal delivery (OVD) is recognised as a major risk factor in the occurrence of obstetric anal sphincter injuries (OASIs), particularly during first vaginal deliveries. Randomised controlled trials (RCTs) have shown the merits of adopting a policy of restrictive mediolateral episiotomy during normal vaginal delivery, although no RCT to date has included measurements of the angle or size of the episiotomy. The benefits of episiotomy performed during OVD demonstrated in large observational studies are overwhelming (Sultan et al. Eur J Obstet Gynecol Reprod Biol. 2019;240:192-196) .Ankarcrona et al have added another study to this collection and have confirmed the results of most such publications. In their study, based on 11 years of data from the Swedish Medical Birth Register, they have emulated a RCT using propensity scores. Ultimately, both methods used showed an almost identical risk reducing effect as the commonly used logistic regression analysis. demonstrating a significant reduction in OASIs during vacuum extraction associated with the use of mediolateral or lateral episiotomies. The Number Needed to Treat to prevent one OASI was 27, which is known to be fourfold lower in forceps delivery.Is the episiotomy a treatment for a certain condition or disease? In reality, episiotomy is an intervention to reduce the risk for an unwanted side effect of birth. Consequently, the impact is one of risk modification as opposed to treatment. Similar to the study by Ankarcrona et al risk factors are commonly established with the use of observational studies (RCOG Greentop guideline No 29, 2015) . In the last decade, several large observational studies Involving more than 2 million women showed a significantly lower rate of OASI in nulliparous women undergoing OVD with an episiotomy.Given the availability of such studies, based on registered databases, showing significantly lower OASI rates, is there still a need for further evidence? Ankarcrona et al acknowledge Lund et al who have shown in their systematic review that there is an association between the risk reduction for OASI with episiotomy rates; the greatest reduction was shown in studies with episiotomy rates over 70%.Obstetricians opposing the use of routine episiotomy during OVD highlight the lack of a definitive RCT. RCT’s are commonly used to address the treatment effect of an intervention on a particular condition with a well described outcome. However, RCT’s of episiotomy during OVD have proven to be very difficult and usually compare no more than the liberal versus the restricted use of episiotomy. As Ankarcrona et al mention, there is only one pilot RCT of IVD and episiotomy indicating that 1600 OVD will need to be included for a definitive study. However, we believe that the design of such a study should be two separate arms for forceps and vacuum delivery as the inherent risks with/without an episiotomy is different. Such a study with vacuum extraction is currently underway in Sweden.The challenge now is to identify prior to labour which women are at high risk of sustaining OASIS using prediction models based on the pre-existing large national databases.

Objective • Prioritising normal birth has led to harm in some instances in the UK • Australian organisations have also promoted normal birth in maternity practice • The negative impact of normal birth appears less well understood in Australia • The study explores this impact of normal birth promotion and the quality of clinical incident investigations Design • Survey-based research design Setting • Online survey Population or Sample • Australian maternity health care providers Methods • Open and close-ended questions on the survey • The survey received 1278 responses • Data analysed using SPSS software Main Outcome Measures • Perceptions on bias against or delay in interventions • Perceptions on systemic attempts to reduce caesarean rates • Perceptions on clinical incident investigations and the engagement of women in these processes Results • Promoting normal birth may by introduce bias against or delay interventions • Attempts to reduce caesarean section rates may reduce the agency of the woman to choose how she births • Incident investigations appear to be independent and improve outcomes for mothers and babies • Women with birth trauma appear to lack support and follow up postnatally Conclusions • Current regulatory standards for maternity services may need to be re-evaluated • Key performance indicators for maternity services need to change to reflect core ethical and legal obligations around informed consent

Objective To assess if delivery mode and duration of labour in a first labour of spontaneous onset is associated with gestational length, delivery mode 3and neonatal outcome in the subsequent pregnancy. Study Design Retrospective analysis of prospectively collected data. Setting 15 Maternity units in North West London (1988 to 2000). Population 30,840 women with spontaneous onset of labour in pregnancy 1 and a subsequent birth reported in the same database. Methods Assessment of outcomes by mode of delivery in pregnancy 1, restricting the analysis to the difference in the gestational length between pregnancy 1 and 2. Main Outcome Measures Gestational length, mode of delivery and neonatal unit admission in pregnancy 2. Results Caesarean section (CS) in the first or second stage of labour in pregnancy 1 was associated with pregnancy 2 being a median of 5 and 8 days shorter and a preterm birth rate of 6.0% and 10.1% respectively, whereas following a spontaneous or instrumental birth in pregnancy 1 the median duration was similar, with preterm delivery rates of 4.5% and 3.9%. 56.2% of women with a CS in pregnancy 1 had a repeat CS and 12.5% of their babies were admitted to neonatal unit, compared with 5.3% of women with vaginal birth. Longer labours were associated with shorter gestations in pregnancy 2. Conclusions Compared to vaginal birth, an emergency CS in the first term pregnancy is associated with a shorter gestational length, increased rate of repeat CS and increased risk of NNU admission in the next pregnancy.

Background Pregnancy and liver cirrhosis is a rare but increasing combination. Liver cirrhosis can raise the chance of maternal and fetal mortality and morbidity, although the exact risks remain unclear. Objective To provide a systematic literature review and meta-analysis on maternal, fetal and obstetric complications among pregnant women with liver cirrhosis. Search strategy We performed a systematic literature search in the databases PubMed/MEDLINE and EMBASE (Ovid) from inception through 25 January 2021. Selection criteria Studies including pregnancies with liver cirrhosis and controls were eligible. Data collection and analysis Two reviewers independently evaluated study eligibility. We used the random-effects model for meta-analysis. Main results Our search yielded 3118 unique papers. We included 11 studies, including 2912 pregnancies in women with cirrhosis from 1982-2020. Seven studies were eligible for inclusion in the meta-analysis. The overall maternal mortality rate was 0.89%. Maternal mortality and variceal hemorrhage decreased comparing recent and older studies. Most cases of maternal mortality due to variceal hemorrhage (70%) occurred during vaginal delivery. Pregnant women with liver cirrhosis had a higher chance of preterm delivery (OR 6.7 95% CI 5.1- 9.1), cesarean section (OR 2.6, 95% CI 1.7-3.9), preeclampsia (OR 3.8, 95% CI 2.2-6.5) and small for gestational age neonates (OR 2.6, 95% CI 1.6-4.2) compared to the general obstetric population. Subgroup-analyses could not be conducted. Conclusions Liver cirrhosis in pregnant women is associated with serious increases in maternal mortality and obstetric and fetal complications. Large international prospective studies are needed to identify risk factors for unfavorable outcome.

Placenta accreta spectrum: Welcome progress and a call for standardization.Mini-commentary for BJOG on Kayem et al 2021 BJOG-20-1462R3Placenta accreta spectrum (PAS) is among the most feared causes of maternal morbidity worldwide, and yet few prospective data are available to inform best practice. PAS is rare enough that rigorous study in a single center is difficult, but common enough that most obstetric hospitals now encounter PAS. Management and outcomes vary strikingly between hospitals and best practice, regrettably, is guided more by expert consensus than by level I evidence. In fact, most clinical questions regarding management of PAS are informed by essentially no prospective data (Collins et al. Am J Obstet Gynecol. 2019;220:511-526).Into this data void has come the PACCRETA cohort (Kayem et al. Act Obstet Gynecol Scand 2013;92:476-482) and some of its first results, published in this issue of BJOG (Kayem et al. BJOG 2021). PACCRETA is a prospective population-based study from 176 hospitals in France, capturing 30% of all French deliveries, from from 2013 to 2015. The study investigators identified 249, or 4.8 per 10,000, cases of PAS.Of all PAS patients, Kayem and colleagues found that a full half did not have the classic combination of risk factors for PAS (previa with history of cesarean). This group had lower morbidity and milder disease than those with the classic combination. Only 17% of those without classic risk factors were diagnosed antenatally. The message here is mixed: those without classic PAS risk factors are less likely to be diagnosed antenatally (bad) but appear to suffer less morbidity overall (good).But did these patients actually have PAS? Only 21% of those without prior cesarean and previa had a hysterectomy. Although this could be due to a regional preference for conservative treatments, the presence of false positives seems likely. Without a hysterectomy specimen, the diagnosis of PAS is difficult, controversial, and (in our opinion) highly susceptible to overdiagnosis. The authors define “strict” criteria for true cases of PAS, but several criteria depended entirely on the subjective assessment of a clinician faced with a difficult placental removal and the flawed principle of PAS as diagnosis of exclusion . Difficulty in manual placental removal or massive bleeding from an implantation site does not always indicate that microscopic PAS was present. Similarly, areas of prior cesarean section scar dehiscence (windows) where the placenta can be seen through the serosa are often diagnosed as percreta (Figure) without any histological evidence of the villous tissue having invaded through the serosa or beyond (Hecht et al. Modern Pathol 2020;33:2382-2396).We congratulate Kayem and colleagues for the current study and all of their important contributions to our understanding of PAS. However, these data illustrate the need for standardization of the definition of PAS, especially in conservatively managed cases with considerable potential for misdiagnosis. There is a desperate need for controlled studies of patients with antenatally suspected PAS with detailed and objective documentation of imaging, intra-operative findings, and when available, histopathological examination. In absence of such studies, the void of definitive data to guide treatment options will remain wide open.

Re: Training in the use of intrapartum electronic fetal monitoring with cardiotocography: systematic review and meta‐analysis. Cardiotocography training is a complex intervention and requires complex evaluations: a letter to editor.Lightly K, Weeks AD, Scott HCorrespondence to Dr Kate Lightly – klightly@liverpool.ac.uk07875642837Clinical Research Fellow, Sanyu Research Unit, University of Liverpool and Liverpool Women’s NHS Foundation Trust, members of Liverpool Health Partners, Crown Street, Liverpool, L8 7SS.Professor Andrew D WeeksProfessor of International Maternal Health, Sanyu Research Unit, University of Liverpool and Liverpool Women’s NHS Foundation Trust, members of Liverpool Health Partners, Crown Street, Liverpool, L8 7SS.Professor Hazel ScottDean of School of Medicine, School of Medicine, University of Liverpool, Cedar House, Liverpool, L69 3GE.Running title - CTG training requires complex evaluationsWe congratulate Kelly et al on their review on the effects of training in cardiotocography (CTG).i It is a critical step towards understanding how to correctly implement CTG training. However, we query the relevance of some of the included studies and whether using Kirkpatrick’s model adequately captures all of the relevant complexities. We believe that further work is needed to understand how such training will impact on practice.Some of the CTG research projects reviewed were poorly representative of the needs of clinicians tasked with improving fetal monitoring in their hospitals. For clinicians, their population of interest is practising clinicians who work on labour wards (sometimes infrequently); studies involving undergraduates alone may not be generalisable. Training in intermittent auscultation is also relevant. Considerable detail on the training intervention is required, including not only the format of teaching, but the duration, curriculum and proportion of relevant staff trained. Detail is also required of supporting interventions and context, as training alone is unlikely to impact change. Many would consider ‘no training’ unethical and therefore not a relevant comparator . In the UK, CTG training and competency is now required for all maternity staff.ii The ultimate aim of CTG (and therefore CTG training) is to detect the hypoxic fetus, so that timely intervention can be undertaken to avoid perinatal harm, without unnecessary intervention. Therefore, the outcomes of interest have to include intrapartum stillbirths, hypoxic ischaemic encephalopathy and mode of delivery.Kirkpatrick’s model was used in this review to evaluate training at four levels (reaction, knowledge, behaviour change and organisational performance). However, it does not attempt to understand why interventions work, or the context, or the causal pathways between training and change in practice.iii Whether participants like training (‘reaction’) is of little relevance, and knowledge acquisition (‘knowledge’) is a proxy which does not equate with improved on the job performance and outcomes. Maternal and perinatal outcomes (‘performance’) were only collected in a small number of studies.CTG training is a complex intervention which aims to create change, not simply knowledge acquisition. We therefore believe that a formal Realist Evaluation is needed. This emerging methodology has been used successfully to understand healthcare change processes and supplement traditional Cochrane style reviews. It aims to understand why complex interventions work, how, for whom, in what context and to what extentiv. Collaboration with the relevant authors to gain detailed intervention descriptions, with a realist approach, may add some much needed explanatory power to this critical subject.Training alone is unlikely to impact change. Even the best educational package will fail without the necessary support - it needs an educational and working culture which supports learning and change, aligned and clear policies, and motivated, well supported drivers and leaders.How doctors learn and what supports them to put new knowledge into practice are key research questions. High quality, methodologically appropriate, properly funded studies are needed to address these questions. Not answering them means many research findings are redundant, as they simply will not be implemented.ReferencesI Kelly S, Redmond P, King S, Oliver‐Williams C, Lamé G, Liberati E et al. Training in the use of intrapartum electronic fetal monitoring with cardiotocography: systematic review and meta‐analysis. BJOG. 2021; 00: 1–12. https://doi.org/10.1111/1471-0528.16619ii NHS England. Saving Babies’ Lives Version Two. A care bundle for reducing perinatal mortality. London: NHS England 2019. [cited 2021 Feb 3]. Available from: www.england.nhs.ukiii Moreau KA. Has the new Kirkpatrick generation built a better hammer for our evaluation toolbox? Med Teach. 2017 Sep; 39(9): 999-1001. https://doi.org/10.1080/0142159X.2017.1337874iv Wong G, Westhorp G, Greenhalgh J, Manzano A, Jagosh J, Greenhalgh T. Quality and reporting standards, resources, training materials and information for realist evaluation: the RAMESES II project. Health Services and Delivery Research. 2017 5 (28): 1–108. https://doi.org/10.3310/hsdr05280.Acknowledgements – NilDisclosure of interests - NilContribution to authorshipKL wrote the first draft of this letter and then it was revised by AW and HS.Details of ethics approval – N/AFunding – Dr Lightly’s PhD entitled “Improving intrapartum fetal monitoring in India: A mixed methods approach” is funded by MRC/DfID/Wellcome Trust Joint Global Health Trials Fund. MR/R006/1801

Objective: To test the hypothesis that compared to single layer continuous uterine suture (SLCUS), a double layered purse string uterine suture (PSUS) significantly reduces cesarean scar defect (CSD) rates, without increasing the perioperative maternal morbidity. Design : Interventional prospective, randomized study . Setting: University obstetric units in Tunisia. Population: 100 pregnant women with an indication of a planned Caesarean. Methods: Patients were enrolled in 2 groups according to the uterine suture technique: SLCUS or PSUS. A Saline infusion hysterosonography was performed by the same senior obstetrician blinded to the uterine suture technique 6 months after surgery . Main Outcome measures: Operative time and Calculated blood loss (CBL) were used for the short time analysis . Uterine and CSD measurements were used for the mid time analysis . Results : Despite a few minutes longer operative time in SUS group (7.17 ± 2.31 min Vs. 6.31 ± 3.04 min, p = 0.028 in SLCUS group; p <10‾³); there was no significant difference in terms of CBL (520 ± 58 in SUS group vs. 536 ± 50 ml in SLCUS group, p = 0.724). The medium-term analysis showed a significant decrease in the rate of CSD with the PSUS: 6.66% vs.40% with SLUCS; p = 0.002. Moreover, SLUCS was the leading risk factor for CSD : adjusted OR=6 ;95% CI [0- 1],p < 10‾³) . Conclusion : Compared to single layer continuous suture, purse string uterine suture significantly reduces cesarean scar defect rates, without increasing the perioperative maternal morbidity. NCT03930134. https://clinicaltrials.gov/ct2/show/NCT03930134

Objectives: To accurately assess the vertical transmission rate of Methicillin-resistant Staphylococcus aureus (MRSA) and its clinical impacts on pregnant mothers and neonates. Design: A prospective observational cohort study. Setting: Japan. Population: 898 pregnant women and their 905 neonates delivered in gestation week > 32+0 at Toyooka Hospital from August 2016 to December 2017. Methods: MRSA was cultured from the nasal and vaginal samples taken from mothers at enrollment and the nasal and umbilical samples taken from neonates immediately after their birth. We examined the vertical transmission rate of MRSA in mother-neonate pairs. We used multivariable logistic regression to identify maternal/neonatal adverse outcomes associated with maternal MRSA colonization. Main outcome measures: The frequency of maternal/neonatal MRSA colonization and adverse outcomes. Results: The prevalence of maternal MRSA colonization was 6.1% (55/898), and that of neonates was 0.8% (8/905). The prevalence of neonatal MRSA was 12.7% (7/55 mother-neonate pairs) in the MRSA-positive mothers, whereas it was only 0.12% (1/843 pairs) in the MRSA-negative mothers (OR: 121, 95% CI: 14.6-1000). When the maternal vaginal-MRSA was positive, the vertical transmission rate was 44.4% (4/9). Skin and soft tissue infections (SSTIs) developed significantly more frequently in neonates born to the MRSA-positive mothers (OR: 7.47, 95% CI: 2.50-22.3). Conclusions: The prevalence of MRSA in pregnant women was approximately 6%. The vertical transmission rate of vaginal MRSA was as high as 44.4%. Maternal MRSA colonization is associated with increased development of neonatal SSTIs via vertical transmission.

Background: Cervical cerclage has been used for decades to decrease rates of preterm birth. The Shirodkar and McDonald cerclage are the two most commonly used cerclage techniques with no current consensus on the preferred technique. Objective: To compare the efficacy of the two techniques. Search strategy: Studies were sourced from six electronic databases and reference lists. Selection criteria: Studies including women with a singleton pregnancy, requiring a cervical cerclage, using either the Shirodkar or McDonald technique that ran comparative analyses between the two techniques. Data collection and analysis: The primary outcome was preterm birth before 37 weeks, with sub analyses at 28, 32, 34 and 35 weeks. Secondary data was also collected on neonatal, maternal and obstetric outcomes. Main results: Seventeen papers were included - analysis showed the Shirodkar group had significantly less chance of preterm birth before 37 weeks (RR 0.91, 95% CI 0.85-0.98). This finding is reinforced by statistically significant reduction in rates of preterm birth before 37, 35, 34 and 32 weeks, PPROM (RR 0.87 ,95% CI 0.77 – 0.99), difference in cervical length (mean difference 5.25, 95% CI 4.68–5.83), cerclage to delivery interval (mean difference 10.79, 95% CI 8.20-13.38), and an increase in birthweight (mean difference 348 grams, 95% CI 291–406) in the Shirodkar group. Conclusion: Shirodkar cerclage leads to a significant reduction in preterm birth and delivers better maternal and neonatal outcomes when compared to McDonald cerclage. Funding: No funding was required for this review. Keywords: Cervical, Stitch, Cerclage, McDonald, Shirodkar, Preterm birth

Objective: To determine if the racial and ethnic compositions of the participants in Obstetrics and Gynecology randomized controlled trials (RCTs) conducted in the U.S. match that of the general U.S. population. Design: Retrospective analysis of U.S. RCTs. Setting: United States. Population: Women enrolled in U.S. RCTs. Methods: Racial and ethnic composition of RCT participants published in two premier US journals, Obstetrics and Gynecology and American Journal of Obstetrics and Gynecology, from January 2010 to April 2020 were collected and analyzed. Main outcome measures: Comparison of the racial and ethnic composition of the U.S. RCTs to U.S. General population. Results: Chi-square analysis showed significant deviations from the U.S. general population in both Obstetrics (p<0.001) and Gynecology (p<0.05). We observed an overrepresentation of Black race and an underrepresentation of White and Asian races overall Obstetrics and in most subcategories. We observed an overrepresentation of Black race and an underrepresentation of Asian race in Gynecology overall and in most subcategories. White race representation was similar to the general population on average, but with wide variation across studies especially among the subcategories. Hispanic ethnicity was overall underrepresented. Conclusions: RCTs in the field of Obstetrics and Gynecology conducted in the U.S. deviate from the general population with regard to racial and ethnic distributions. Funding: NC,YW, CP, JG and SL received stipend from University of Chicago Metcalf summer internship program and Odyssey and Empower summer program. Keywords: U.S. Randomized Controlled Trials, Racial and Ethnic Backgrounds, Obstetrics and Gynecology

OBJECTIVE: The objective of this study was to evaluate C-section rates, before and after the implementation of the Project Appropriate Birth based on the Robson 10-group classification system. DESIGN: An observational, cross-sectional study. SETTING: Maternity hospital in South Brazil. POPULATION: All pregnant women attending, April 2016 through April 2017 (phase 1, pre-implementation of the Project Appropriate Birth) and June 2017 through June 2018 (phase 2, post-implementation of the Project Appropriate Birth). METHODS: Maternal and obstetric characteristics were evaluated, including Robson’s classification, based on the characteristics of pregnancy and childbirth. Chi-square test and crude and adjusted prevalence ratios were used to analyze study variables. The significance level was set at 5%. MAIN OUTCOME MEASURES: C-section rate for each group, their contribution to the overall c-section rate and the differences in these contributions before and after PPA implementation. RESULTS: C-section rates decreased from 62.4% to 55.6%, which represented a 10.9% reduction after the implementation of the Project Appropriate Birth. Pregnant women in Robson classification groups 1 through 4 had the greatest decrease in C-section rates, ranging from 49.1% to 38.6%, which represents a 21.5% reduction. The greatest contributors to the overall C-section rates were group 5 and group 2, accounting for more than 60% of the C-section deliveries. CONCLUSION: The Project Appropriate Birth had an important impact on the reduction of C-section rates, especially in Robson classification groups 1 through 4, which indicates that providing mothers with evidence-based interventions for labor and childbirth assistance will contribute to reduce C-section rates.

Abstract Objective: To compare current the third stage management to expedient squatting at 3 minutes postpartum. Design, Setting, Sample and Methods: A retrospective cohort study of 1,098 planned, attended low risk vaginal births in Israel using Judy’s 3,4,5 minute third stage protocol compared to 2,691 attended low risk vaginal births in British Columbia using various forms of active or expectant management of the third stage of labor. Main Outcome measures: PPH>1000, PPH>500 and manual removal of placenta Results: Among similar groups of low risk births, active management, or expectant management resulted in 4.1% PPH over 1000 cc, whereas Judy’s 3,4,5 minute protocol resulted in 0% PPH over 500 cc. Conclusion: Evidence supports less postpartum bleeding and postpartum hemorrhage when women deliver the placenta in squatting 3 minutes after birth. The risks are minimal and the data suggests the likelihood of a very positive outcome, making it recommended for practitioners in all settings to try it.

The management of Post-Dural Puncture Headache; a prospect from a low and middle-income country: A viewpoint.

Objective: to compare the vaginal birth rate in women with previous one lower segment caesarean section when induced at 40 weeks compared to expectant management till 41 weeks. Design: A randomized controlled trial Setting: Department of Obstetrics and Gynaecology, JIPMER, a tertiary care teaching institution in the south of India. Population or Sample: Low-risk women with previous one single lower segment caesarean section with a singleton foetus in vertex presentation and eligible for a trial of labour (TOLAC) at 40 weeks gestation. Methods: Block randomization to two groups of thirty each. The induction group was induced at 40 weeks with low dose oxytocin infusion or ripening with a single application of a single balloon Foley catheter followed by oxytocin infusion 24 hours later. The expectant group was managed in the hospital with maternal and foetal surveillance and induced at 41 weeks if they had not delivered by then. Main Outcome Measures: Vaginal birth after caesarean section (VBAC). Results: The demography and pregnancy variables were comparable in the two groups. Twenty out of thirty women (66.67%) had a successful vaginal birth after caesarean section in the induction group compared to ten out of 30 (33.33%) in the expectant group. This difference was significant (RR 2.0, 95% CI: 1.13-3.52; P=0.016) Conclusions: Among low-risk women with previous one lower segment caesarean section willing and eligible for TOLAC, the successful VBAC rate is significantly higher among those induced at 40 weeks compared to those managed expectantly till 41 weeks.

Background: Systematic reviews of clinical trials frequently reveal heterogeneity in the number and types of outcomes reported. To counteract this, a Core Outcome Set (COS) may be applied. Objectives: A systematic review of all completed and ongoing COS related to pregnancy and childbirth Search strategy: COMET up to January 2020, Ovid MEDLINE, EMBASE, PsycINFO, Academic Search Elite, CINAHL and SocINDEX up to June 2019. Selection criteria: Studies which prioritized outcomes using some form of consensus method (such as the Delphi technique) were included. Data collection and analysis: All included studies were checked for compliance with the Core Outcome Set–STAndards for Reporting. Information about population, setting, method and outcomes was extracted. Main results: Nineteen completed studies and thirty-nine ongoing studies were included. The number of outcomes included in various COS ranged from 6 to 48. Most COS were for conditions related to physical complications during pregnancy. No COS were identified for perinatal mental health. Conclusion: This review discloses a growing number of COS within the field of pregnancy and childbirth. Many of the completed studies follow the proposed reporting. However, several of the COS included a large number of outcomes. There is a need to consider the number of outcomes which may be included in a COS while retaining its applicability in future research. Funding This article is adapted from a report undertaken by the SBU, who provided funding for the study. Keywords: Childbirth, Core outcome set, Maternal health, Obstetric care, Pregnancy

Objective: Given growing interest in alternatives to hospital birth, particularly given the COVID-19 pandemic, we developed a peripartum intervention risk calculator (PIRC) to estimate maternal and neonatal risk of requiring hospital-based peripartum intervention. Design: National cohort study. Setting: United States. Sample: Hospital births captured by the Pregnancy Risk Assessment Monitoring System from 2009-2018. Methods: The cohort was stratified by receipt of hospital-based interventions, defined as: 1) operative vaginal delivery (forceps or vacuum), 2) cesarean delivery, or 3) requiring neonatal intensive care unit admission. Gravidas with prior cesarean delivery or fetal malformation were excluded. Main Outcome Measures: Risk of requiring hospital-based intervention. Results: A total of 63,234 births were evaluated (72.6% full-term, 48.5% nulliparous) including 37.9% who received one or more hospital–based interventions. Gestational age was the most predictive factor of requiring hospital-based intervention, with lowest odds at 400/7-406/7 weeks. Previous live births (Ref: none; 1, OR 0.41; 2, OR 0.35; ≥3, OR 0.29; p<0.05 for all) were protective. Other predictors included advanced maternal age, high pre-pregnancy body mass index, maternal diabetes, maternal hypertension, and not exercising during pregnancy. The resulting seven-factor model demonstrated strong discrimination (optimism corrected C-statistic=0.776) and calibration (mean absolute error=0.009). Conclusions: We developed and validated the PIRC for predicting individualized risk for hospital-based intervention among gravidas based on seven readily accessible prenatal factors. This calculator can support personalized counseling regarding planned birth setting, helping to close a critical gap in current clinical guidance and providing an evidence-based risk assessment for those contemplating alternatives to hospital birth.

Objective To develop a Core Outcome Set (COS) for treatment of perinatal depression Design Systematic overview of outcomes reported in the literature and consensus development study using a Delphi survey and modified nominal group technique. Setting International. Population Two hundred and twenty-two participants, representing thirteen countries. Methods A systematic overview of outcomes reported in recently published research, a two-round Delphi survey, a consensus meeting at which the final COS was decided. Main results In the literature search, 1772 abstracts were identified and evaluated, 284 papers/protocols were assessed in full and 165 studies were finally included in the review. In all, 106 outcomes were identified and thus included in the Delphi survey. 222 participants registered for the first round of the Delphi survey and 151 (68%) responded. In the second round, 123 (55%) participants responded. The following 9 outcomes were agreed upon for inclusion in the final COS: self-assessed symptoms of depression, diagnosis of depression by a clinician, parent to infant bonding, self-assessed symptoms of anxiety, quality of life, satisfaction with intervention, suicidal thoughts, attempted or committed suicide, thoughts of harming the baby, and adverse events. Conclusions The relevant stakeholders prioritised outcomes and reached consensus on a COS comprising nine outcomes. We hope that this COS will contribute to consistency and uniformity of outcome selection and reporting in future clinical trials involving treatment of perinatal depression Funding This article is adapted from a report by SBU, which provided funding for the study. Keywords: perinatal depression, postpartum depression, antenatal depression, COS