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Background No midwifery-led units existed in Ireland before 2004. The aim of this study was to compare midwife-led (MLU) versus consultant-led (CLU) care for healthy, pregnant women without risk factors for labour and delivery. Methods An unblinded, pragmatic randomised trial was designed, funded by the Health Service Executive (Dublin North-East). Following ethical approval, all women booking prior to 24 weeks of pregnancy at two maternity hospitals with 1,300-3,200 births annually in Ireland were assessed for trial eligibility.1,653 consenting women were centrally randomised on a 2:1 ratio to MLU or CLU care, (1101:552). 'Intention-to-treat' analysis was used to compare 9 key neonatal and maternal outcomes. Results No statistically significant difference was found between MLU and CLU in the seven key outcomes: caesarean birth (163 [14.8%] vs 84 [15.2%]; relative risk (RR) 0.97 [95% CI 0.76 to 1.24]), induction (248 [22.5%] vs 138 [25.0%]; RR 0.90 [0.75 to 1.08]), episiotomy (126 [11.4%] vs 68 [12.3%]; RR 0.93 [0.70 to 1.23]), instrumental birth (139 [12.6%] vs 79 [14.3%]; RR 0.88 [0.68 to 1.14]), Apgar scores < 8 (10 [0.9%] vs 9 [1.6%]; RR 0.56 [0.23 to 1.36]), postpartum haemorrhage (144 [13.1%] vs 75 [13.6%]; RR 0.96 [0.74 to 1.25]); breastfeeding initiation (616 [55.9%] vs 317 [57.4%]; RR 0.97 [0.89 to 1.06]). MLU women were significantly less likely to have continuous electronic fetal monitoring (397 [36.1%] vs 313 [56.7%]; RR 0.64 [0.57 to 0.71]), or augmentation of labour (436 [39.6%] vs 314 [56.9%]; RR 0.50 [0.40 to 0.61]). Conclusions Midwife-led care, as practised in this study, is as safe as consultant-led care and is associated with less intervention during labour and delivery. Trial registration number ISRCTN: ISRCTN14973283

Objective To derive population-based incidence rates of postpartum haemorrhage (PPH) and to investigate trends associated with method of delivery and blood transfusion. Specific focus was given to PPH due to atonic uterus, the commonest type of PPH. Consideration was also given to morbidly adherent placenta, a rare but severe obstetric complication involving abnormally deep placental adherence to the uterine wall. Design Retrospective cohort study Setting Ireland Population All childbirth hospitalisations, 1999 through 2009 Methods Diagnostic codes from hospital discharge records were used to identify cases of PPH due to third stage haemorrhage, uterine atony, postpartum coagulation defects, or delayed and secondary PPH. Receipt of a blood transfusion was used as a proxy to indicate the severity of haemorrhage. Significant temporal trends in PPH incidence were determined using a Cochrane-Armitage test for trend. Multivariate logistic regression was conducted to measure the odds of PPH diagnosis by year of delivery while adjusting for potentially confounding covariates. Main outcome measures PPH due to uterine atony; blood transfusion; morbidly adherent placenta. Results Over the study period, there were 649 019 childbirth hospitalisations, of which 2.6% (n=16 909) included a diagnosis of PPH. The overall PPH rate among hospital-based deliveries increased from 1.5% in 1999 to 4.1% in 2009. The increase in the overall PPH rate was driven by a parallel increase in atonic PPH, which rose from 1.0% in 1999 to 3.4% in 2009. Irrespective of induction status, significant increasing trends in atonic PPH rates were observed across vaginal, instrumental and caesarean deliveries (p Conclusions Analysis of hospital discharge data indicate changing trends in the incidence and severity of PPH due to uterine atony and morbidly adherent placenta. There is a pressing need for case-control studies and detailed clinical audit to identify clinical and patient-related factors associated with these conditions.

Background A key strategy in improving care for people with chronic obstructive pulmonary disease (COPD) is the provision of pulmonary rehabilitation programmes. Pulmonary rehabilitation programmes have been successful in improving patients' sense of dyspnoea and Health Related Quality of Life. However, the effectiveness of structured education pulmonary rehabilitation programmes delivered at the level of the general practice on the health status of people with COPD remains uncertain and there is a need for a robust and fair assessment of this. The PRINCE study will evaluate the effectiveness of a Structured Education Pulmonary Rehabilitation Programme (SEPRP), delivered at the level of the general practice, on the health status of people with COPD. Methods/Design The PRINCE Trial is a two-armed, single blind cluster randomised trial conducted in the primary care setting in Ireland. Randomisation to control and intervention is at the level of the General Practice. Participants in the intervention arm will receive a SEPRP and those allocated to the control arm will receive usual care. Delivery of the SEPRP will be by a practice nurse and physiotherapist in the General Practice (GP) site. The primary outcome measure of the study will be health status as measured by the Chronic Respiratory Questionnaire (CRQ). Blinded outcome assessment will be undertaken at baseline and at twelve-fourteen weeks after completion of the programme. A comparison of outcomes between the intervention and control sites will be made to examine if differences exist and, if so, to what extent between control and experimental groups. Sample size calculations estimate that 32 practices with a minimum of 10 participants per practice are required, in total, to be randomised to control and intervention arms for power of at least 80% with alpha levels of 0.05, to determine a clinically significant change of 0.5 units in the CRQ. A cost effectiveness analysis will also be conducted. Discussion The results of this trial are directly applicable to primary care settings in Ireland. Should a SEPRP delivered by practice nurses and physiotherapists in primary care be found to be effective in improving patients' sense of dyspnoea and HRQoL, then the findings would be applicable to many thousands of individuals in Ireland and beyond. Trial registration ISRCTN: ISRCTN52403063

This study describes the standards, training and audit systems in units offering ultrasound screening services in Ireland. A national survey of 21 of all maternity units offering an obstetric ultrasound service in Ireland was undertaken. The questionnaire used was designed by the UK Screening committee and sought information on nine key areas associated with service provision including protocols for screening, the antenatal ultrasound package available and management following the identification of a fetal abnormality. This paper reports on the availability of information for women, record keeping, standards and training, and monitoring of quality. All units responded to the survey. Deficiencies in the Irish service include limited information available for women who are participating in screening, poor monitoring of ultrasound programmes, suboptimal equipment and a lack of guidelines and standards relating to the conduct of ultrasound examinations Significant improvements are required in order to deliver a national service of a satisfactory standard. Key recommendations include establishing a national working group to develop national standards to audit the service, and to guarantee that staff training is sufficient to ensure effective practice.

BACKGROUND: Active management of the third stage of labour involves giving a prophylactic uterotonic, early cord clamping and controlled cord traction to deliver the placenta. With expectant management, signs of placental separation are awaited and the placenta is delivered spontaneously. Active management was introduced to try to reduce haemorrhage, a major contributor to maternal mortality in low-income countries. This is an update of a review last published in 2015. OBJECTIVES: To compare the effects of active versus expectant management of the third stage of labour on severe primary postpartum haemorrhage (PPH) and other maternal and infant outcomes.To compare the effects of variations in the packages of active and expectant management of the third stage of labour on severe primary PPH and other maternal and infant outcomes. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the World health Organization International Clinical Trials Registry Platform (ICTRP), on 22 January 2018, and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing active versus expectant management of the third stage of labour. Cluster-randomised trials were eligible for inclusion, but none were identified. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias, carried out data extraction and assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included eight studies, involving analysis of data from 8892 women. The studies were all undertaken in hospitals, seven in higher-income countries and one in a lower-income country. Four studies compared active versus expectant management, and four compared active versus a mixture of managements. We used a random-effects model in the analyses because of clinical heterogeneity. Of the eight studies included, we considered three studies as having low risk of bias in the main aspects of sequence generation, allocation concealment and completeness of data collection. There was an absence of high-quality evidence according to GRADE assessments for our primary outcomes, which is reflected in the cautious language below.The evidence suggested that, for women at mixed levels of risk of bleeding, it is uncertain whether active management reduces the average risk of maternal severe primary PPH (more than 1000 mL) at time of birth (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.14 to 0.87, 3 studies, 4636 women, I2 = 60%; GRADE: very low quality). For incidence of maternal haemoglobin (Hb) less than 9 g/dL following birth, active management of the third stage may reduce the number of women with anaemia after birth (average RR 0.50, 95% CI 0.30 to 0.83, 2 studies, 1572 women; GRADE: low quality). We also found that active management of the third stage may make little or no difference to the number of babies admitted to neonatal units (average RR 0.81, 95% CI 0.60 to 1.11, 2 studies, 3207 infants; GRADE: low quality). It is uncertain whether active management of the third stage reduces the number of babies with jaundice requiring treatment (RR 0.96, 95% CI 0.55 to 1.68, 2 studies, 3142 infants, I2 = 66%; GRADE: very low quality). There were no data on our other primary outcomes of very severe PPH at the time of birth (more than 2500 mL), maternal mortality, or neonatal polycythaemia needing treatment.Active management reduces mean maternal blood loss at birth and probably reduces the rate of primary blood loss greater than 500 mL, and the use of therapeutic uterotonics. Active management also probably reduces the mean birthweight of the baby, reflecting the lower blood volume from interference with placental transfusion. In addition, it may reduce the need for maternal blood transfusion. However, active management may increase maternal diastolic blood pressure, vomiting after birth, afterpains, use of analgesia from birth up to discharge from the labour ward, and more women returning to hospital with bleeding (outcome not pre-specified).In the comparison of women at low risk of excessive bleeding, there were similar findings, except it was uncertain whether there was a difference identified between groups for severe primary PPH (average RR 0.31, 95% CI 0.05 to 2.17; 2 studies, 2941 women, I2 = 71%), maternal Hb less than 9 g/dL at 24 to 72 hours (average RR 0.17, 95% CI 0.02 to 1.47; 1 study, 193 women) or the need for neonatal admission (average RR 1.02, 95% CI 0.55 to 1.88; 1 study, 1512 women). In this group, active management may make little difference to the rate of neonatal jaundice requiring phototherapy (average RR 1.31, 95% CI 0.78 to 2.18; 1 study, 1447 women).Hypertension and interference with placental transfusion might be avoided by using modifications to the active management package, for example, omitting ergot and deferring cord clamping, but we have no direct evidence of this here. AUTHORS' CONCLUSIONS: Although the data appeared to show that active management reduced the risk of severe primary PPH greater than 1000 mL at the time of birth, we are uncertain of this finding because of the very low-quality evidence. Active management may reduce the incidence of maternal anaemia (Hb less than 9 g/dL) following birth, but harms such as postnatal hypertension, pain and return to hospital due to bleeding were identified.In women at low risk of excessive bleeding, it is uncertain whether there was a difference between active and expectant management for severe PPH or maternal Hb less than 9 g/dL (at 24 to 72 hours). Women could be given information on the benefits and harms of both methods to support informed choice. Given the concerns about early cord clamping and the potential adverse effects of some uterotonics, it is critical now to look at the individual components of third-stage management. Data are also required from low-income countries.It must be emphasised that this review includes only a small number of studies with relatively small numbers of participants, and the quality of evidence for primary outcomes is low or very low.

The aim of this bi-monthly column is to highlight Cochrane Systematic Reviews of relevance to pregnancy and childbirth and to stimulate discussion on the relevance and implications of the review for practice. The Cochrane Collaboration is an international organisation that prepares and maintains high quality systematic reviews to help people make well-informed decisions about healthcare and health policy. A systematic review tries to search for, appraise and synthesise existing research to answer a specific research question. The Cochrane Database of Systematic Reviews (CDSR) is published monthly online. Residents in countries with a national license to The Cochrane Library, including the UK and Ireland, can access the Cochrane Library online free through www.thecochranelibrary.com.

The aim of this bi-monthly column is to highlight Cochrane Systematic Reviews of relevance to pregnancy and childbirth and to stimulate discussion on the relevance and implications of the review for practice. The Cochrane Collaboration is an international organisation that prepares and maintains high quality systematic reviews to help people make well informed decisions about health care and health policy. A systematic review tries to search for, appraise and synthesise existing research to answer a specific research question. The Cochrane Database of Systematic Reviews (CDSR) is published monthly online. Residents in countries with a national license to The Cochrane Library, including the UK and Ireland, can access the Cochrane Library online free through www.thecochranelibrary.com.

This study describes the use of intrapartum electronic fetal monitoring in Ireland. Electronic fetal monitoring (EFM) has become routine in the assessment of fetal wellbeing during labour. Current evidence indicates that the routine use of EFM leads to an increased caesarean section and operative vaginal delivery rate and a reduction in the rate of neonatal seizures. Practices and service provision related to the use and interpretation of and educational provision for electronic fetal monitoring have not been investigated in Ireland. A national survey of all (n = 22) maternity units in Ireland was undertaken using a self-reported questionnaire amended, with permission, from that used in the 8th CESDI report. The questionnaire sought information on unit birth rate in 2002, number of cardiotocograph (CTG) monitors available in delivery units, use of the admission CTG, use of continuous EFM for women with various risk factors for pregnancy and/or labour, availability of fetal blood sampling facilities, use of umbilical cord blood sampling and availability of guidelines on the use of EFM. All units responded to the survey giving a national picture of the use of EFM during labour. All units had cardiotocograph (CTG) monitors available in the delivery area (median 6, range 3-14). An admission CTG was performed on all women by 96% (n=21) of units. Thirty six per cent of units (n=8) used continuous EFM routinely during labour in women who did not have risk factors for labour. Fetal blood sampling (FBS) was used in 36% (n=8) of units in cases of suspicious CTG tracings. Umbilical cord blood gases were sampled routinely following emergency caesarean section in 46% (n= 10) of units while 64% (n= 14) did so if the baby's condition was poor at birth. A departmental guideline on the use of EFM was available in 73% (n= 16) units. The findings of this survey indicate wide variations in the use of intrapartum EFM in Ireland. The use of continuous EFM for specific high-risk indications was variable and EFM was used by a third of units for women who did not have risk factors for labour. The admission CTG was used by 21 of the 22 units despite evidence of no benefit. The absence of FBS in the majority of units surveyed and the low rate of umbilical cord blood sampling is of concern.

Background We Can Quit2 was a community-based randomised controlled trial which determined the feasibility and acceptability of We Can Quit (WCQ), a peer delivered stop-smoking programme comprising group support and free Nicotine Replacement Therapy (NRT) tailored to women living in socioeconomically disadvantaged areas in Ireland. Reengagement with key stakeholders took place as part of the trial Knowledge Exchange and Dissemination plan, to discuss strategies to optimise community engagement, recruitment and retention in a future definitive trial (DT), and the policy priorities arising from the trial. Methods Community stakeholders involved in trial recruitment and planning, Irish Cancer Society and Health Service Executive representatives were invited to an online interactive workshop in November 2020. Key trial findings were presented. Workshop discussion (field notes) and responses to a post-event anonymous questionnaire informed a list of challenges and suggestions for a future DT and policy development from a community perspective. Results Forty-one stakeholders attended the workshop, six completed the questionnaire. Dedicated additional time for community engagement and use of social prescribing as a recruitment tool were recommended. Greater adaptation of trial data and assistance to complete forms were suggested to address low literacy, which was a barrier to recruitment and retention. An intervention boost after WCQ delivery and encouragement of women to join other healthy community programmes to maintain their group, were recommended to facilitate retention and enhance sustainability. Policy priorities were to remove cost and administrative barriers to access NRT and ongoing provision of cessation services tailored to disadvantaged groups. Conclusions Important strategies to optimise design of a DT of WCQ effectiveness were recommended. Lessons learned may be relevant to other community-based health interventions in socioeconomically disadvantaged areas. Key messages The workshop provided a suitable forum for engagement of community and statutory stakeholders. Knowledge exchange activities facilitated an enhanced research design from a community perspective.

BACKGROUND: Cardiotocography (CTG) is a continuous recording of the fetal heart rate obtained via an ultrasound transducer placed on the mother’s abdomen. CTG is widely used in pregnancy as a method of assessing fetal well‐being, predominantly in pregnancies with increased risk of complications. OBJECTIVES: To assess the effectiveness of antenatal CTG (both traditional and computerised assessments) in improving outcomes for mothers and babies during and after pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (26 June 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi‐randomised trials that compared traditional antenatal CTG with no CTG or CTG results concealed; computerised CTG with no CTG or CTG results concealed; and computerised CTG with traditional CTG. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: Six studies (involving 2105 women) are included. Overall, the included studies were not of high quality, and only two had both adequate randomisation sequence generation and allocation concealment. All studies that were able to be included enrolled only women at increased risk of complications. Comparison of traditional CTG versus no CTG showed no significant difference identified in perinatal mortality (risk ratio (RR) 2.05, 95% confidence interval (CI) 0.95 to 4.42, 2.3% versus 1.1%, four studies, N = 1627, low quality evidence) or potentially preventable deaths (RR 2.46, 95% CI 0.96 to 6.30, four studies, N = 1627), though the meta‐analysis was underpowered to assess this outcome. Similarly, there was no significant difference identified in caesarean sections (RR 1.06, 95% CI 0.88 to 1.28, 19.7% versus 18.5%, three trials, N = 1279, low quality evidence). There was also no significant difference identified for secondary outcomes related to Apgar scores less than seven at five minutes (RR 0.83, 95% CI 0.37 to 1.88, one trial, N = 396, very low quality evidence); or admission to neonatal special care units or neonatal intensive care units (RR 1.08, 95% CI 0.84 to 1.39, two trials, N = 883, low quality evidence), nor in the other secondary outcomes that were assessed. There were no eligible studies that compared computerised CTG with no CTG. Comparison of computerised CTG versus traditional CTG showed a significant reduction in perinatal mortality with computerised CTG (RR 0.20, 95% CI 0.04 to 0.88, two studies, 0.9% versus 4.2%, 469 women, moderate quality evidence). However, there was no significant difference identified in potentially preventable deaths (RR 0.23, 95% CI 0.04 to 1.29, two studies, N = 469), though the meta‐analysis was underpowered to assess this outcome. There was no significant difference identified in caesarean sections (RR 0.87, 95% CI 0.61 to 1.24, 63% versus 72%, one study, N = 59, low quality evidence), Apgar scores less than seven at five minutes (RR 1.31, 95% CI 0.30 to 5.74, two studies, N = 469, very low quality evidence) or in secondary outcomes. AUTHORS' CONCLUSIONS: There is no clear evidence that antenatal CTG improves perinatal outcome, but further studies focusing on the use of computerised CTG in specific populations of women with increased risk of complications are warranted.

Objectives: This is a protocol for a Cochrane Review (qualitative). The objectives are as follows:. This is a protocol for a Cochrane Review (qualitative). The review aims to explore the factors associated with a person’s decision to take part in a pandemic or epidemic vaccine trial.

Background Striae gravidarum (stretch marks developing during pregnancy) occur in 50% to 90% of women. They appear as red or purple lines or streaks that fade slowly to leave pale lines or marks on the skin. The abdomen, breasts and thighs are commonly affected. The exact cause of stretch marks is unclear and no preparation has yet been shown to be effective in preventing the development of stretch marks. They are a source of significant anxiety for women, impacting on their quality of life. Objectives To assess the effects of topical preparations on the prevention of stretch marks in pregnancy. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2011) and reference lists of retrieved reports. Selection criteria We included randomised controlled trials and quasi-randomised controlled trials comparing topical preparations (with active ingredients) with other topical preparations (with active ingredients), with a placebo (that is, preparations without active ingredients) or with no treatment for the prevention of stretch marks in pregnant women. Data collection and analysis Three review authors independently assessed trial eligibility and trial quality, and extracted data. Data were checked for accuracy. The primary outcome was the presence of stretch marks and the secondary outcome was the severity of stretch marks. Main results We included six trials involving 800 women. Of the six trials, we judged the risk of bias for three as 'low risk' for random sequence generation, blinding of participants and personnel, blinding of outcome assessment, completeness of outcome data and selective reporting. There was no statistically significant average difference in the development of stretch marks in women who received topical preparations with active ingredients compared to women who received a placebo or no treatment (average risk ratio (RR) 0.74; 95% confidence interval (CI) 0.53 to 1.03; five trials, 474 women; random-effects model, Tau² = 0.09, I² = 65%) (Analysis 1.1). Results were consistent with the main effects when we performed a sensitivity analysis excluding studies judged to be at high risk of bias for random sequence generation, allocation concealment or more than 20% missing data for a given outcome (average RR 0.81; 95% CI 0.60 to 1.10; four trials, 424 women; random-effects model, Tau² = 0.05, I² = 57%). The was no statistically significant average mean difference in the severity of stretch marks (standardised mean difference (SMD) -0.31; 95% CI -1.06 to 0.44; two trials, 255 women; Tau² = 0.26, I² = 87%). There was no statistically significant difference in the development of stretch marks in women who received topical preparations with active ingredients compared to women who received other topical preparations with active ingredients (average RR 0.51; 95% CI 0.16 to 1.60; two trials, 305 women; Tau² = 0.53, I² = 74%). There was no statistically significant difference in the severity of stretch marks (mean difference (MD) -0.20; 95% CI -0.53 to 0.13; one trial, 206 women; heterogeneity not applicable). Authors' conclusions We found no high-quality evidence to support the use of any of the topical preparations in the prevention of stretch marks during pregnancy. There is a clear need for robust, methodologically rigorous randomised trials involving larger sample sizes to evaluate the effects of topical preparations on the development of stretch marks in pregnancy. In addition, it is important that preparations commonly used by women to prevent and treat stretch marks are evaluated within the context of robust, methodologically rigorous and adequately powered randomised trials.

International audience; BackgroundResearchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against COVID-19. Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluated.MethodWe performed a living mapping of RCTs registered in the WHO International Clinical Trials Registry Platform. We systematically search the platform every week for all RCTs evaluating preventive interventions and treatments for COVID-19 and created a publicly available interactive mapping tool at https://covid-nma.com to visualize all trials registered.ResultsBy August 12, 2020, 1,568 trials for COVID-19 were registered worldwide. Overall, the median ([Q1-Q3]; range) delay between the first case recorded in each country and the first RCT registered was 47 days ([33-67]; 15-163). For the 9 countries with the highest number of trials registered, most trials were registered after the peak of the epidemic (from 100% trials in Italy to 38% in the United States). Most trials evaluated treatments (1,333 trials; 85%); only 223 (14%) evaluated preventive strategies and 12 post-acute period intervention. A total of 254 trials were planned to assess different regimens of hydroxychloroquine with an expected sample size of 110,883 patients.ConclusionThis living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Most trials were registered when the first peak of the pandemic have passed.