Georgina Andersson

and 10 more

Background: In 2023-24, 33% of labours were induced in England. The prostaglandin dinoprostone is commonly used, but evidence is increasing that misoprostol may be a better alternative. Objectives: Compare the efficacy and safety of vaginal dinoprostone with vaginal misoprostol for labour induction. Search Strategy: Electronic databases (Medline, Scopus, CINAHL, Cochrane Central Register) were searched in 2025. Selection Criteria: Randomised controlled trials comparing singleton, term inductions with vaginal dinoprostone or misoprostol published after 2000. Primary outcome was vaginal births within 24 hours. Secondary outcomes included birth mode, induction to birth interval, oxytocin augmentation, uterine hyperstimulation and adverse maternal or neonatal outcomes. Data Collection and Analysis: Data extraction used a standardised proforma including the Cochrane Risk of Bias. A random effects meta-analysis was performed using R. Main Results: From 8,529 records, 44 papers reported 7,040 participants induced with vaginal misoprostol and 6,604 with dinoprostone. Risk of bias was moderate. Participants given misoprostol were 48% (OR 1.48 95% CI 1.20, 1.84) more likely to achieve vaginal birth within 24 hours compared with those given dinoprostone, although heterogeneity was high. The rates of the above-mentioned secondary outcomes were comparable. In the misoprostol group, fewer patients required augmentation with oxytocin (OR 0.51 95% CI 0.40, 0.65). Conclusion: Induction of labour with vaginal misoprostol seems to improve the rate of vaginal birth within 24 hours when compared to dinoprostone without increasing the incidence of adverse events with fewer patients requiring oxytocin augmentation. We encourage consideration of vaginal misoprostol as a first-line agent for labour induction.

Andrew Weeks

and 2 more

Author responseAndrew D WeeksProfessor of International Maternal Health / Consultant ObstetricianUniversity of Liverpool / Liverpool Women’s HospitalCrown Street, Liverpool L8 7SSaweeks@liverpool.ac.ukSarah EspenhahnMaternity Service User Voice Lead for Londonsarah.espenhahn1@nhs.netSusie CrowePresident, British Intrapartum SocietyConsultant Obstetrician and GynaecologistBarts Health NHS TrustWhipps Cross Road, London E11 1NR.Susanna.crowe2@nhs.netCorresponding Author:Professor Andrew D WeeksProfessor of International Maternal HealthUniversity of LiverpoolLiverpool Women’s HospitalCrown Street, Liverpool L8 7SS, UKaweeks@liverpool.ac.ukDear Professor Papageorghiou,We thank Matthews et al for their response1 to our article on the ‘Maternity Crisis’.2We do not write as representatives of ‘the institution’ but as frontline staff and a service user representative, trying to improve NHS maternity care. We share many of the authors’ concerns about institutional care and are highly motivated to improve both patient safety and the experience of service users, with a focus on creating the infrastructures and culture that provides personalised, equitable care for all.Moving forward, it is critical that maternity services keep listening to families and service users. Alongside that, they need to work with staff to improve care. The NHS staff will need to put into practice the needed improvements in service provision, and so they also need to be supported, as a stressed and demoralised workforce is unlikely to provide optimal care.3,4 Our article was deliberately written from their perspective to explain the rapid and necessary changes that are occurring within a backdrop of extremely limited resource. If we fail to understand any unintended consequences of positive change then it will only hinder the service transformation that we are seeking.We all have a common interest in improving maternal and neonatal outcomes, including service user experience. We need to be allies in doing this. It’s time to stop talking in silos and all lean into difficult conversations together, healthcare professionals and service users alike.

Arsheeya RATTAN

and 11 more

Background: Post-partum haemorrhage (PPH) is a common complication of labour. Objective: To assess the effectiveness of oxytocin in comparison to no treatment for the prevention of PPH. Selection criteria: Published and unpublished randomised controlled trials (RCTs) comparing systemic oxytocin to placebo or no intervention for the prevention of PPH were included. We did not apply language restrictions. Search Strategy: We identified RCTs from the Cochrane network meta-analysis on uterotonics for the prevention of PPH and updated the search via: Ovid MEDLINE, Embase via Ovid, Web of Science, CENTRAL, CINAHL Plus and clinicaltrials.gov. Data collection and analysis: An Individual participant data (IPD) meta-analysis. Main results: Of 14 eligible RCTs, four provided IPD (n=4,304; 51.7% received oxytocin and 48.4% received placebo or no intervention). Meta-analysis of IPD showed that oxytocin decreased the risk of PPH≥500 mL (aOR 0.59; 95% CI 0.46 to 0.74) and PPH≥1000 mL (aOR 0.51; 95%CI 0.32 to 0.80). Of ten RCTs that did not share data, seven met trustworthiness criteria while three did not. Trustworthy IPD and aggregate data from RCTs meeting trustworthiness criteria (n=6,003) showed that oxytocin significantly reduced the rate of PPH≥500 mL (aOR 0.53; 95%CI 0.45 to 0.62) and PPH≥1000 mL (aOR 0.59; 95%CI 0.48 to 0.71). Three RCTs not meeting trustworthiness criteria (n=1,027) reported a larger risk reduction of oxytocin for PPH≥500mL (aOR 0.37; 95%CI 0.03 to 4.03) and PPH≥1000mL (aOR 0.13; 95%CI 0.01 to 1.45). Conclusions : Prophylactic oxytocin reduces the risk of PPH≥500mL and PPH≥1000mL compared to no treatment. Studies not meeting trustworthiness criteria reported a larger effect, underlining the importance of integrity assessment in MA.

Andrew Weeks

and 14 more

Objective: To assess the acceptability, safety and efficacy of the PPH Butterfly, a new uterine compression device, in women with postpartum haemorrhage (PPH). Design: A phase two clinical device trial using matched historical controls, with accompanying grounded theory study. Setting: UK university consultant obstetric unit. Population: women with PPH after vaginal birth unresponsive to initial oxytocin therapy. Outcomes were compared to historical controls matched on blood loss, parity and type of birth. Methods: after oral consent, trained staff used the device in additional to normal care. Main Outcome Measures: The primary outcome was additional blood loss >1000mls. Qualitative interviews assessed device feasibility and acceptability. Results: Of the 57 recruits, two-thirds were primiparous and almost half had undergone operative birth. Two percent of recruited women had additional blood loss of over 1000mls compared to 8% of 113 controls (adjusted odds ratio 0.13, 95% CI (0.02 to 1.09)). Women treated with the device received significantly more additional treatments and had higher rates of exclusive breast-feeding at discharge. There were no serious adverse events related to the device. In 47 interviews, participants, birth partners, clinicians and attending midwives viewed the device positively. Clinicians found it useful to stop blood loss and diagnose the source of bleeding. Conclusions: the PPH Butterfly is acceptable and may have clinical benefits: it is a promising device for PPH management. Funding: National Institute for Health Research invention for innovation (i4i) program (II-LA-0715-200008) Keywords: postpartum haemorrhage, childbirth, oxytocin, third stage of labour, uterine compression. Registration: prospective ISRCTN (15452399); www.isrctn.com/ISRCTN15452399
BJOG-20-2353.R2 What should we believe when systematic reviews disagree?For many years, uterine balloon tamponade (UBT) has been used to treat severe postpartum haemorrhage (PPH), despite a lack of randomised trials to demonstrate its effectiveness. With commercial devices being expensive, clinicians in low resource settings have made their own using 2 low-cost, widely available items (Foley catheters and condoms). Public health experts have been so confident of their benefit that large programmes have been set up to disseminate the necessary skills worldwide.Recently, however, the global maternal health community has been thrown into disarray when not one, but two randomised controlled efficacy trials suggested that outcomes with condom catheter UBTs were actuallyworse than normal care in low resource settings. The Cochrane meta-analysis concluded that “in [low resource] settings, balloon tamponade [should be] only introduced alongside multi‐system improvements in PPH care” (Kellie et al. Cochrane Database of Systematic Reviews 2020(7): CD013663).Systematic reviews may be the pinnacle of evidence-based medicine, but even they can differ in how to interpret evidence. And so, proponents of the condom catheter conducted their own systematic review with far wider inclusion criteria – they not only included the randomised trials but examined success rates from 15 non-randomised trials and 69 case series (Suarez et al. Am J Obstet Gynecol 2020;222(4):293.e1–e52). Furthermore, the primary outcome was the success rate of the technique (overall 86%) rather than the risk of morbidity and mortality compared to controls, as used in the Cochrane review. This is problematic, as reported ‘success rates’ without controls can be very difficult to interpret: in initial case series misoprostol showed similar success rates against life-threatening haemorrhage before RCTs eventually showed it to be less effective than oxytocin.A third version of the same review is published today by a WHO team (Pingray et al. BJOG 2021;XXX,XXX). This time they include only 4 high quality studies in which UBT was compared to standard care. With a composite maternal morbidity / mortality outcome, they found no evidence of benefit and concluded that “the effect … is unclear, as is the role of the type of device and the setting”. WHO studies are now underway to address this uncertainty.But why is this all so important? The difficulty comes because the World Health Organisation has been updating its guidance on PPH management, and had to declare a position on UBT. The recently-published guideline, drawn up by independent experts, accepts the validity of the RCTs but recognises that there is wide acceptability of the technique and that the evidence of harm is only for condom catheters and onlyin resource-poor settings. They put a high emphasis on minimising harm and conclude that UBTs should only be used in settings where there is already a good standard of care, including recourse to blood transfusion and surgery if needed (WHO. Geneva: World Health Organization; 2021).Until further studies are published, the debate will continue. But this episode shows how the choice of inclusion criteria and outcomes in systematic reviews are critical, both for their conclusions, and for global policy.

Kate Lightly

and 2 more

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