The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. In an accompanying research study in PLOS Medicine, Landman and ...colleagues report on a randomised controlled trial designed to assess the effectiveness of low-dose aspirin in the prevention of preterm birth in women at high risk of preterm birth 5. The sample size calculation for the APRIL trial was based on a potential 35% relative reduction in the rate of preterm birth (which the authors state was based on the average risk reduction in preterm birth seen in secondary analyses of other trials of aspirin), from a background rate of 36%. Evaluation of low-dose aspirin in the prevention of recurrent spontaneous preterm labour (the APRIL study): A multicentre, randomised, double-blinded, placebo-controlled trial.
Summary Background Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed ...to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage. Methods C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349. Findings Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 95% CI 0·79 to 1·40; adjusted risk difference 0·002 95% CI –0·02 to 0·03). Interpretation Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes. Funding National Institute of Health Research Health Technology Assessment Programme.
Timely interventions in women presenting with preterm labour can substantially improve health outcomes for preterm babies. However, establishing such a diagnosis is very challenging, as signs and ...symptoms of preterm labour are common and can be nonspecific. We aimed to develop and externally validate a risk prediction model using concentration of vaginal fluid fetal fibronectin (quantitative fFN), in combination with clinical risk factors, for the prediction of spontaneous preterm birth and assessed its cost-effectiveness. Pregnant women included in the analyses were 22.sup.+0 to 34.sup.+6 weeks gestation with signs and symptoms of preterm labour. The primary outcome was spontaneous preterm birth within 7 days of quantitative fFN test. The risk prediction model was developed and internally validated in an individual participant data (IPD) meta-analysis of 5 European prospective cohort studies (2009 to 2016; 1,783 women; mean age 29.7 years; median BMI 24.8 kg/m.sup.2 ; 67.6% White; 11.7% smokers; 51.8% nulliparous; 10.4% with multiple pregnancy; 139 7.8% with spontaneous preterm birth within 7 days). The model was then externally validated in a prospective cohort study in 26 United Kingdom centres (2016 to 2018; 2,924 women; mean age 28.2 years; median BMI 25.4 kg/m.sup.2 ; 88.2% White; 21% smokers; 35.2% nulliparous; 3.5% with multiple pregnancy; 85 2.9% with spontaneous preterm birth within 7 days). The developed risk prediction model for spontaneous preterm birth within 7 days included quantitative fFN, current smoking, not White ethnicity, nulliparity, and multiple pregnancy. After internal validation, the optimism adjusted area under the curve was 0.89 (95% CI 0.86 to 0.92), and the optimism adjusted Nagelkerke R.sup.2 was 35% (95% CI 33% to 37%). On external validation in the prospective UK cohort population, the area under the curve was 0.89 (95% CI 0.84 to 0.94), and Nagelkerke R.sup.2 of 36% (95% CI: 34% to 38%). Recalibration of the model's intercept was required to ensure overall calibration-in-the-large. A calibration curve suggested close agreement between predicted and observed risks in the range of predictions 0% to 10%, but some miscalibration (underprediction) at higher risks (slope 1.24 (95% CI 1.23 to 1.26)). Despite any miscalibration, the net benefit of the model was higher than "treat all" or "treat none" strategies for thresholds up to about 15% risk. The economic analysis found the prognostic model was cost effective, compared to using qualitative fFN, at a threshold for hospital admission and treatment of greater than or equal to2% risk of preterm birth within 7 days. Study limitations include the limited number of participants who are not White and levels of missing data for certain variables in the development dataset. In this study, we found that a risk prediction model including vaginal fFN concentration and clinical risk factors showed promising performance in the prediction of spontaneous preterm birth within 7 days of test and has potential to inform management decisions for women with threatened preterm labour. Further evaluation of the risk prediction model in clinical practice is required to determine whether the risk prediction model improves clinical outcomes if used in practice.
To assess the effects of aspirin in pregnancy for the prevention of adverse outcomes in low risk, nulliparous women with singleton pregnancies.
Medline, Embase, CINAHL, the Cochrane library, Web of ...Science and clinicaltrials.gov were searched from inception until February 2020. Randomised controlled trials were eligible for inclusion where women were nulliparous, had singleton pregnancies and no other risk factors for pre-eclampsia such as diabetes or pre-existing hypertension. Primary outcomes were pre-eclampsia, gestational hypertension and eclampsia. Secondary outcomes included; pre-term birth, postpartum haemorrhage, antepartum haemorrhage, miscarriage, small for gestational age (SGA), fetal growth restriction (FGR), birthweight and further markers of maternal and neonatal morbidity and mortality. The results were combined into meta-analysis where appropriate.
Ten studies were eligible for inclusion involving 23,162 women. Two studies (involving 214 women) used aspirin doses of 100 mg, with the remainder using smaller doses. There was no significant difference found in the risk of developing pre-eclampsia between women receiving aspirin compared to no aspirin (relative risk RR 0.70, 95 % confidence interval CI 0.47–1.05, p = 0.08). Women receiving aspirin had a reduced risk of having a preterm birth <34 weeks (RR 0.50, 95 % CI 0.26−0.96, p = 0.04), and reduced risk of having a SGA neonate (RR 0.94, 95 % CI 0.89–1.00, p = 0.04). An increase in birthweight was seen when aspirin was received (mean difference 105.17 g, 95 % CI 12.38 g–197.96 g, p = 0.03) and there was no increase in risk of postpartum or antepartum haemorrhage in those receiving aspirin (RR 1.24, 95 % CI 0.90–1.71, p = 0.19 and RR 1.06, 95 % CI 0.66–1.70, p = 0.81 respectively).
The results did not demonstrate a significant difference amongst low risk nulliparous women in the risks of pre-eclampsia or gestational hypertensive disorders with aspirin administration. Although we found significantly improved fetal growth parameters and prevention of preterm birth in women receiving aspirin, there were few eligible studies, with those included generally providing low quality evidence and many studies using aspirin doses ≤100 mg, commenced late in pregnancy. More research in the form of a high quality randomised controlled trial is needed before recommendations can be made.
Abstract Objectives Chorioangiomas are the most frequently occurring type of benign tumour of the placenta. However, large chorioangiomas greater than 4 cm are rare and can be more frequently ...associated with serious complications such as: polyhydramnios, hydrops fetalis, fetal anaemia, intrauterine growth restriction, preterm birth, and an increased risk of perinatal mortality. Importantly timely prenatal diagnosis with close surveillance alongside potential intrauterine intervention can prove impactful on pregnancy outcome and fetal survival. Case presentation We present a case of a 36-year-old female referred to our tertiary fetal medicine unit at 28 weeks’ gestation with a large chorioangioma measuring 9.4×8.8×5.5 cm and ultrasonographic evidence of severe fetal anaemia and fetal hydrops. The patient underwent an intrauterine transfusion and in utero surgical therapy with radiofrequency ablation (RFA). Immediately following the procedure, the fetus sustained a period of bradycardia, followed by asystole. Delivery was expedited via emergency caesarean section. Careful planning and rapid delivery after fetal intervention within the most appropriate surgical setting mitigated risks for the baby and resulted in a positive outcome. The baby was discharged from the neonatal unit on day 84 of life. Conclusions Large placental chorioangiomas are a rare occurrence, however, when associated with fetal complications present a high incidence of adverse perinatal outcomes. In utero interventions require careful planning and surgical expertise to ensure improved fetal and neonatal outcomes. To the best of our knowledge this case is the first recorded instance of a successful postnatal outcome following RFA for a large placental chorioangioma, whereby the fetus was complicated by fetal hydrops.
IntroductionChildbirth-related perineal trauma (CRPT) is the most common complication of childbirth affecting 80% of women overall after vaginal birth. There remains a lack of comprehensive evidence ...relating to the prevalence of subsequent health problems. Current evidence is related to short-term outcomes, for example, pain, but there is less known about longer-term outcomes such as infection, wound dehiscence, pelvic floor function and psychological outcomes. This is a protocol for a cohort study assessing outcomes of women after CRPT.Methods and analysisA multicentre, prospective UK cohort study aiming to include 1000 women. All women who have sustained CRPT will be eligible for inclusion and will be followed-up for 12 months after childbirth. The primary outcome will be perineal infection at 6 weeks post-birth. Secondary outcomes will include antibiotic use for perineal infection, wound breakdown, use of analgesia, the requirement for admission or surgical intervention, urinary and faecal incontinence, anxiety and depressive symptoms, sexual function and impact on daily activities. Outcomes will be measured at 6 weeks, 6 months and 12 months post partum, with some outcomes being measured at all time points and others at selected most appropriate time points only. Outcome data will be obtained from a review of clinical notes and from patient questionnaires. Simple descriptive statistics will be used to summarise characteristics and outcomes, with categorical variables expressed as percentages and continuous variables as mean averages, alongside the corresponding standard deviatons.Ethics and disseminationEthical approval has been granted by the Research Ethics Council with reference 23/WA/0169. Data collected from the Childbirth Acquired Perineal Trauma (CHAPTER) cohort study will highlight the prevalence and type of complications after CRPT and which women are more at risk. After the conclusion of this study, findings will be used to work with governmental organisations and Royal Colleges to target resources and ultimately improve care.
We describe the utility and impact of a distributed leadership model to implement a National Health Service (NHS) England Academic Health Sciences national quality improvement programme, in the West ...Midlands. This model was adopted to address the inherent difficulties of implementing change in practice in a large geographical region with a diverse population of health service personnel. We report on the inclusion of a senior trainee as part of the implementation team, supported by a multidisciplinary clinical consultant team, with equal agency in decision making, acting as mentors and activators in the background.
•Surgical site infection prevention post-caesarean is of the utmost importance.•Surgical site infection incidence poses clinical and economic implications.•Dialkylcarbamoyl chloride dressings prevent ...surgical site infection post-caesarean.•Silver dressings do not effectively prevent surgical site infection post-caesarean.•Further trials of advanced dressings post-caesarean section are required.
Surgical site infections (SSIs) are a common complication post-caesarean section. Advanced dressings aim to provide an optimal wound environment, primarily by physically or chemically controlling moisture, in order to promote timely healing. A systematic review and meta-analysis was conducted to evaluate the effectiveness of advanced dressings in SSI prevention post-caesarean section. Secondary effectiveness outcomes included superficial SSI, endometritis, wound dehiscence, rehospitalisation and length of rehospitalisation.
We conducted a systematic review and meta-analysis according to PRISMA guidelines. A protocol was registered a priori. MEDLINE, EMBASE, CENTRAL and CINAHL databases were searched from inception to May 2021, without date or language restrictions. Keywords included: caesarean section; bandages; dressing and surgical wound infection. Randomised controlled trials (RCTs) were included if they investigated any advanced dressing in women post-caesarean section compared to simple dressings and assessed SSI incidence. Relative risks (RR), with 95% confidence intervals (CIs) and p-values, were calculated using Review Manager software (RevMan version 5.0, The Cochrane Collaboration). I2 percentages were reported to assess heterogeneity and a funnel plot was produced to assess publication bias. Quality assessment was performed using the Cochrane Risk of Bias Assessment Tool. All data were double-extracted and discrepancies were finalised by a third reviewer.
From 253 citations identified, six RCTs were included in the systematic review and meta-analysis. Two studies investigated dialkylcarbamoyl chloride (DACC)-impregnated dressings; two investigated silver-impregnated dressings; one investigated copper-impregnated dressings and one investigated chlorhexidine gluconate dressings. The overall meta-analysis showed that advanced dressings did not reduce SSI risk (RR 0.81 95% CI 0.52–1.24; p = 0.32). However, subgroup analysis revealed that DACC-impregnated dressings reduced SSI risk (RR 0.33 95% CI 0.14–0.77; p = 0.01). Silver-impregnated dressings caused a nonsignificant increase in SSI risk (RR 1.20 95% CI 0.77–1.88; p = 0.41). All studies showed a high risk of bias.
This systematic review and meta-analysis suggests DACC dressings potentially reduce SSI. However we have shown no benefit of silver dressings. Further high-quality RCTs are required to recommend a change in clinical practice.
In England, 27.8% of all pregnant women undergo caesarean sections (CS) to deliver their babies. Women undergoing CS are at risk of developing sepsis and post-natal infections, which not only ...contribute significantly to maternal mortality and morbidity, but also negatively impact upon post-natal recovery and wellbeing. This study explores patients' priorities in relation to CS recovery, focusing on their knowledge and experiences of infection prevention. The study formed part of the PREPS (Vaginal Preparation at caesarean section to Reduce Endometritis and Prevent Sepsis - a feasibility study of chlorhexidine) Trial; patients' views on the PREPS Trial were also sought.
Using qualitative methodology, two focus groups and six telephone interviews were carried out between September and October 2017 with a total of 21 women who had undergone a CS within the preceding six months. Focus groups and individual telephone interviews were audio-recorded and transcribed verbatim; a thematic analysis was conducted using NVivo 11.
Women's priorities around CS recovery centred on pain (or the lack thereof), mobility and the ability to resume everyday activities, including caregiving. Those undergoing a CS for the first time reported not feeling confident in their ability to identify signs of infection and sought visiting health professionals' expertise and reassurance. Women were unable to recall whether they had received information regarding infection prevention and felt that they had not received sufficient advice. Some reported receiving general information regarding CS recovery, which ranged in quality. Prevention of womb infection is a major goal of the PREPS trial, however, the majority of women were not aware that womb (as opposed to wound) infection was a post CS risk.
Women undergoing a CS want more information on what constitutes a 'normal' post-operative recovery and specifically would welcome written information and infection prevention advice. This should be a key element of improving post-CS maternal experiences and potentially reducing sepsis and infection rates. CS stigma negatively impacts women's recovery experiences and possibly information provision. The PREPS team incorporated findings regarding consent pathways for recruiting women into intrapartum research and developed two patient reported outcomes to collect in the main trial.
The PREPS trial has been registered with ISRCTN on the 10th July 2017 ( ISRCTN33435996 ).
IntroductionThe aim of the QUIDS study is to develop a decision support tool for the management of women with symptoms and signs of preterm labour, based on a validated prognostic model using ...quantitative fetal fibronectin (fFN) concentration, in combination with clinical risk factors.Methods and analysisThe study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts, USA) which quantifies fFN in a vaginal swab. In QUIDS part 2, we will perform a prospective cohort study in at least eight UK consultant-led maternity units, in women with symptoms of preterm labour at 22+0 to 34+6 weeks gestation to externally validate a prognostic model developed in QUIDS part 1. The effects of quantitative fFN on anxiety will be assessed, and acceptability of the test and prognostic model will be evaluated in a subgroup of women and clinicians (n=30). The sample size is 1600 women (with estimated 96–192 events of preterm delivery within 7 days of testing). Clinicians will be informed of the qualitative fFN result (positive/negative) but be blinded to quantitative fFN result. Research midwives will collect outcome data from the maternal and neonatal clinical records. The final validated prognostic model will be presented as a mobile or web-based application.Ethics and disseminationThe study is funded by the National Institute of Healthcare Research Health Technology Assessment (HTA 14/32/01). It has been approved by the West of Scotland Research Ethics Committee (16/WS/0068).VersionProtocol V.2, Date 1 November 2016.Trial registration number ISRCTN 41598423andCPMS: 31277.
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