Obstetrics and Gynaecology

Induction of labour versus standard care to prevent shoulder dystocia in fetuses suspected to be large for gestational age in the UK (the Big Baby trial): a multicentre, open-label, randomised controlled trial (2025)

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Type of publication:

Randomised controlled trial

Author(s):

Gardosi, Jason; Ewington, Lauren Jade; Booth, Katie; Bick, Debra; Bouliotis, George; Butler, Emily; *Deshpande, Sanjeev; Ellson, Hanna; Fisher, Joanne; *Gornall, Adam; Lall, Ranjit; Mistry, Hema; Naghdi, Seyran; Petrou, Stavros; Slowther, Anne-Marie; Wood, Sara; Underwood, Martin; Quenby, Siobhan.

Citation:

Lancet. 2025 May 01.

Abstract:

BACKGROUND: The benefits and harms of early induction of labour to reduce shoulder dystocia in fetuses suspected to be large for gestational age (LGA) are uncertain. We aimed to investigate whether early induction of labour is associated with a reduced risk of shoulder dystocia compared with standard care.

METHODS: In this open-label, randomised controlled phase 3 trial, women aged >=18 years with a suspected LGA fetus (estimated fetal weight >90th customised percentile) as identified by ultrasound scan between 35 weeks and 0 days (35+0 weeks) of gestation and 38+0 weeks' gestation, recruited from 106 hospitals across England, Scotland, and Wales in the UK, were randomly assigned (1:1) by web app to standard care or induction of labour between 38+0 weeks' gestation and 38+0 weeks' gestation using minimisation, balancing site, estimated fetal weight percentile (<=95th EFW percentile or >95th EFW percentile), and maternal age (<=35 years or >35 years). Key exclusion criteria included drug-treated diabetes, gestational diabetes, and elective caesarean section or induction already planned or indicated for any reason. Our primary outcome was incidence of shoulder dystocia, assessed by a masked independent expert adjudication panel who reviewed participants' delivery notes. Induction of labour was anticipated to result in birth 10.5 days earlier with a 300 g lower birthweight on average than standard care. We did an intention-to-treat (ITT) analysis in all participants for whom we had primary outcome data, and a per-protocol analysis in participants in the induction group who went into labour or were induced at 38+0 to 38+0 weeks' gestation versus participants in the standard care group who had not started labour, been induced, or had an elective caesarean section before 38+0 weeks' gestation. This study was registered with ISRCTN (18229892) and is no longer recruiting.

FINDINGS: Between June 8, 2018, and Oct 25, 2022, 2893 women were randomly assigned to induction of labour (n=1447) or standard care (n=1446); the trial was terminated before the target of 4000 participants was reached on advice of the data monitoring committee following the lower-than-expected incidence of shoulder dystocia in the standard caregroup. Two participants in the induction group and seven in the standard care group had missing data for the primary outcome and were excluded from the ITT analysis. In the ITT analysis, 33 (2.3%) of 1445 babies in the induction group versus 44 (3.1%) of 1439 in the standard care group had shoulder dystocia (risk ratio [RR] 0.75 [95% CI 0.51-1.09]; p=0.14) with a mean difference of -6.0 days' (95% CI -6.3 to -5.6) gestation and -163.6 g (-190.0 to -137.1) birthweight between trial groups. 355 (24.6%) of 1446 mothers in the standard care group were induced, delivered, or went into labour at or before 38+0 weeks' gestation. In the per-protocol analysis, 27 (2.3%) of 1180 babies in the induction group versus 40 (3.7%) of 1074 in the standard care group had shoulder dystocia (RR 0.62 [0.41-0.92]; p=0.019), and there was a mean difference of -8.1 days' (-8.4 to -7.9) gestation and -213.3 g (-242.0 to -184.6) birthweight between trial groups. One neonatal death occurred from perinatal asphyxia after shoulder dystocia in the standard care group, and one neonatal death occurred following sepsis and congenital pneumonia in the induction group. 88 (6.1%) of 1447 mothers in the induction group had an adverse event versus 108 (7.5%) of 1446 in the standard care group (RR 0.81 [0.62 to 1.06]; p=0.13). Similar numbers of serious adverse events were reported in both groups.

INTERPRETATION: No significant difference in incidence of shoulder dystocia was found between trial groups in the ITT analysis, probably due to the high proportion of earlier-than-expected deliveries in the standard care group reducing the intended between-group differences in gestational age and birthweight. However, in the per-protocol analysis, compared with all deliveries after 38+0 weeks' gestation, induction of labour between 38+0 weeks' gestation and 38+0 weeks' gestation did show a significant reduction in shoulder dystocia. This study provides pregnant women with suspected LGA fetuses and their clinicians important information about choices and decision making for timing and mode of birth.

DOI: 10.1016/ S0140-6736(25)00162-X

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Time perception in shoulder dystocia management; a secondary analysis of the prospective cohort simulation SAFE study (2025)

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Type of publication:

Journal article

Author(s):

*Papoutsis D.; Klazoglou P.; Valasoulis G.; Tzavara C.;

Citation:

European Journal of Obstetrics and Gynecology and Reproductive Biology. 311 (no pagination), 2025. Article Number: 114016. Date of Publication: 01 Jul 2025.

Abstract:

Objective: The aim of this study was to explore and quantify the potential improvement and retention of time perception in a simulated childbirth complicated by shoulder dystocia with use of high-fidelity simulation. Method(s): This was a secondary analysis of the previously conducted prospective cohort SAFE study. Registered midwives and final year Midwifery students were invited to attend a one-day workshop in 6-monthly intervals at the University of Western Macedonia in Greece between October 2021-November 2022. There was a 30-minute initial assessment, a 30-minute theoretical and hands-on training, and a 30-minute post-training assessment on shoulder dystocia management. We identified the actual-time and the self-reported perceived-time of delivery at the start and end of each workshop and measured the difference between them to determine if there was any improvement and retention of time perception through consecutive workshops. Result(s): The baseline workshop recruited 101 participants with mean age of 26.7 +/- 9.8 years (range:20-59), of which 53 participated at the 6 month and 33 at the 12 month workshop. There was a significant improvement in time perception by approximately 34.8 % at the end of the baseline workshop, which was retained after 6 and 12 months. 80.2 % of participants experienced a 'time-distortion effect' towards the same direction and felt that the simulated delivery lasted longer than the actual time recorded by the birthing simulator. Those who were more competent at the start of the baseline workshop demonstrated a better time perception. Conclusion(s): The skill of time perception in shoulder dystocia can be improved and retained through simulation training.

DOI: 10.1016/j.ejogrb.2025.114016

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Managing obstetric bleeding in Wales: A qualitative evaluation of the OBS Cymru care bundle using Normalisation Process Theory (2025)

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Type of publication:

Journal article

Author(s):

Rai, Tanvi; Hinton, Lisa E; Mackay, Rosa; Black, Mairead; Sanders, Julia; Slade, Pauline; *Elsmore, Amy; Dhadda, Amrit; *Parry-Smith, William; Collis, Rachel; Petrou, Stavros; Stanworth, Simon; Pallman, Philip; Townson, Julia; Fye, Haddy; Geden, Ayse Gur; Collins, Peter; Bell, Sarah.

Citation:

PLoS ONE [Electronic Resource]. 20(4):e0320754, 2025.

Abstract:

BACKGROUND: Post-partum haemorrhage (PPH) is one of the leading causes of maternal mortality and morbidity worldwide. The Obstetric Bleeding Strategy (OBS) care bundle for PPH management was adopted into Welsh national guidelines in 2019 (as OBS Cymru), and is currently being implemented across 36 sites in the rest of the UK through the OBS UK stepped-wedge cluster randomised controlled trial. We conducted a qualitative evaluation of the OBS care bundle five years after its adoption to inform plans for optimising its implementation across the UK.

METHODS: We conducted ethnographic observations, informal conversations and qualitative interviews with multidisciplinary teams (MDT) in four maternity units in Wales. Data were analysed thematically and usingNormalisation Process Theory.

RESULTS: The OBS Cymru protocol was used daily and MDT members believe it improves the quality and safety of PPH management. The paper proforma supporting OBS Cymru was the 'boundary object' that kept the care bundle in view while clarifying individualised roles across the MDT during a PPH and prompting improved and continuous communication as bleeding progressed. The standardisation of processes through the care bundle was seen as enabling all staff with an overall knowledge of PPH care, while situating the prominence of their particular roles within a greater whole. Enacting the bundle in practice varied slightly across different settings, according to staffing structures (e.g., in delivery rooms versus theatre births) and caseload, and some residual tensions remained regarding expectations from different staff members and levels of support provided regarding OBS Cymru.

CONCLUSIONS: Despite some small-scale variations, OBS care bundle has become normalised as standard PPH care in Wales. Insights from this evaluation, such as the centrality of the proforma in holding the bundle together, and need for greater clarity in staff role expectations, have informed implementation plans for the OBS UK trial.

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Is It Cost-Effective to Induce Labour Early to Prevent Shoulder Dystocia? Evidence From the Big Baby Trial (2025)

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Type of publication:

Journal article

Author(s):

Naghdi, Seyran; Petrou, Stavros; Underwood, Martin; *Deshpande, Sanjeev; Quenby, Siobhan; Ewington, Lauren; Gardosi, Jason; Mistry, Hema.

Citation:

BJOG: An International Journal of Obstetrics & Gynaecology. 2025 May 01. [epub ahead of print]

Abstract:

BACKGROUND: The cost-effectiveness of early induction of labour for suspected large-for-gestational-age foetuses to prevent shoulder dystocia is unknown.

METHODS: A within-trial economic evaluation of induction at 38 + 0 to 38 + 4 weeks' gestation for suspected large-for-gestational-age foetuses. Resource use and costs were measured to 6 months postpartum. We estimated incremental cost per case of shoulder dystocia prevented and incremental cost per maternal quality-adjusted life year (QALY) gained. We collected data for planned caesarean sections in a cohort study.

FINDINGS: Mean combined woman and infant costs in the induction arm were 89 (95% confidence interval (CI): -79, 257) higher than the standard care arm, driven by increased neonatal costs. The incremental cost of preventing one case of shoulder dystocia was 11 879 and the incremental cost per maternal QALY gained was 39 518. The probability of early induction being cost-effective was 0.65 at a cost-effectiveness threshold of 20 000 per case of shoulder dystocia prevented, but 0.36 at a cost-effectiveness threshold of 20 000 per maternal QALY gained. The cohort study found the mean cost was 310 (95% CI: 74, 545) higher in the induction arm than in the planned caesarean group.

INTERPRETATION: Early induction of labour increased neonatal care costs. It is not a cost-effective approach when effects are restricted to maternal QALYs. Planned caesarean section might be cost-saving when compared to early induction, although we did not assess longer-term effects such as an increased risk of repeat caesarean sections. Assessments of long-term effects on the mother and infant should be
incorporated into future studies.

TRIAL REGISTRATION: ISRCTN18229892.

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Image-guided brachytherapy for locally advanced cervical cancer: audit of practice at UHNM 2023 and re-audit 2024 (2025)

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Type of publication:

Conference abstract

Author(s):

Perera J.; Bhana R.; *Choudhury Y.; Devleena D.; Seedhouse I.; Tsui S.M.

Citation:

Clinical Oncology. Conference: SUPP: RCR Audit & QI ePoster Competitions 2024. InterContinental Hotel, Dubai Festival City United Arab Emirates. 40(Supplement 1) (no pagination), 2025. Article Number: 103820. Date of Publication: 01 May 2025.

Abstract:

Category: Gynaecology Background to the audit: Standard treatment for locally advanced cervix cancer consists of chemoradiotherapy followed by brachytherapy. Trial data show shortening overall treatment time and escalation of doses to the high-risk clinical target volume (HR-CTV) to be associated with better local control. Image-guided brachytherapy (IGBT) enables greater dose conformity and local control.<sup>1-6</sup>UHNM commenced a magnetic resonance-based IGBT service for cervical cancer in 2016. Standard: BGCS/ESGO/ESTRO/ESP/ASTRO guidelines on management of cervical cancer.<sup>7-9</sup>1. Overall treatment time should not exceed 49-56 days. 2. Total equivalent dose in 2 Gy fractions (EQD2) to 90% of the HR-CTV (D90) to be >=85 Gy. Indicator: Percentage of patients meeting each standard. Target: 100% having overall treatment less than 56 days. 90% achieving the dose to HR-CTV targets keeping organs at risk(OAR) within tolerence. Methodology: Retrospective analysis of data on IGBT for radical cervical cancer treatments from 1 January 2021 to end of March 2023 done and reviewed at May 2023 UHNM brachytherapy meeting. Initial time span selected to minimise impact of COVID. Action plan implemented and patient data for April 2023 to April 2024 re-audited. Results of first audit round: 43 UHNM and Shrewsbury patients treated. Overall treatment time data available only for 20 UHNM patients. 1 (5%) had exceeded 56 days and 7 (35%) had taken 50-56 days to complete. 37/43 (86.1%) had received a D90 HR-CTV of >85 Gy. A linear relationship between external beam radiation therapy (EBRT) completion to brachytherapy start with total treatment duration identified. First action plan: Pathway changes made to commence chemoradiotherapy on Monday/Tuesday and to schedule the whole course of chemoradiotherapy and brachytherapy at the time of referral. Ring and tandem commissioned as a priority to allow more applicator options. Results of second audit round: All 26 (100%) UHNM and Shrewsbury patients had completed treatments within 56 days. 73.1% within 49 days. 1 outside patient's chemoradiotherapy data incomplete. HR-CTV D90 >85 Gy in 85.2%. 8 patients treated with ring and tandem with 60% more needle use compared with ovoids. No patient exceeded mandatory OAR tolerences. Second action plan: Proactively scheduling brachytherapy, liaising with the regional network monthly to optimise timing and resources usage. To continue with dosimetric data collection to optimise needle placement and to review impact of needles on OAR doses and clinical outcomes in the next audit.

Rising incidence of necrotising fasciitis: a gynaecological perspective (2025)

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Type of publication:

Journal article

Author(s):

*Kaur, Harpreet; *Adekunle, Adeoye; *Ritchie, Joanne; *Rachaneni, Suneetha.

Citation:

BMJ Case Reports. 18(4), 2025 Apr 08.

Abstract:

Necrotising fasciitis is an uncommon and rapidly progressive surgical emergency. A high index of clinical suspicion, prompt administration of broad-spectrum antibiotics and emergency surgery to debride affected tissues are key to improving survival. With our review of three cases, we aim to raise awareness of this condition among gynaecologists, who have limited familiarity with it. Two of our patients presented to emergency with vulval necrotising fasciitis while the third developed it as a complication of postoperative wound infection. All patients underwent extensive surgical debridement and required a multidisciplinary approach from gynaecologists, surgeons, the intensive care team and the tissue viability team.

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The OASI Care Bundle (OASI: Obstetric Anal Sphincter Injury) (2024)

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Type of publication:

Service improvement case study

Author(s):

*Hannah Evans

Citation:

SaTH Improvement Hub, December 2024

Abstract:

By implementing the OASI Care Bundle at our Trust, we aim to reduce the risk of OASI and ultimately reduce the incidence of severe perineal trauma and improve outcomes for pelvic health. This can be achieved by education, awareness and information provision for both maternity staff and service users.

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Ethnic and Socioeconomic Variation in Pre-Conception Long-Term Conditions: A Cross-Sectional Electronic Health Record Study of 3.4 Million Pregnancies in CPRD Aurum (2025)

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Type of publication:

Journal article

Author(s):

Cockburn N.; Singh M.; Wambua S.; Gonzalez-Izquierda A.; Lee S.I.; Phillips K.; *Elsmore A.; *Ilaalagan R.; Holland R.; Hanley S.J.; Laws E.; Hodgetts-Morton V.; Gibbon M.; Judd N.A.; Seymour R.G.; Taylor B.; Chandan J.S.; *Parry-Smith W.; Nirantharakumar K.

Citation:

SSRN. (no pagination), 2025. Date of Publication: 23 Jan 2025 [preprint]

Abstract:

Background: Inequalities in pregnancy outcomes between different ethnic groups and backgrounds of deprivation have been observed in the UK and elsewhere for several decades. Pre-existing long-term health conditions increase risks of adverse outcomes and require focussed action to diagnose, prevent, and manage these conditions. We aimed to estimate differences in the prevalence of pre-conception long-term conditions between different groups to assess health needs.

Methods: This was a cross-sectional study conducted in primary care using Clinical Practice Research Datalink (CPRD) Aurum data. Diagnostic information was extracted from CPRD Aurum at the beginning of all eligible pregnancies for 79 conditions between 2000 and 2021. Age-standardised was estimated and risk ratios calculated between the overall population, and ethnic groups and Index of Multiple Deprivation quintiles. Statistical process control was used to detect conditions with elevated prevalence within groups.

Findings: In 2021, at the start of a pregnancy, women from ethnic minority groups were less likely to have been diagnosed with any one of the 79 conditions than the general population. Women from mixed ethnic groups were 4% more likely to be diagnosed, and from white ethnic groups 2% more likely to be diagnosed. Women from black groups were 5% less likely to be diagnosed, from Asian groups 26%, other ethnic groups 32%, and women missing ethnic group information 13%. Women living in the most deprived quintile of areas were 8% more likely to have been diagnosed than the overall population, and from least deprived areas 8% less likely to have been diagnosed.

Interpretation: Pre-existing long-term conditions are a major driver of maternal morbidity and mortality, but the healthcare needs and policy priorities differ substantially between ethnic and socially disadvantaged groups. Universal health policies that narrow inequalities and targeted action are both needed to meet health needs equitably.

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Placenta accreta spectrum: imaging and diagnosis (2025)

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Type of publication:

Journal article

Author(s):

*Self A.; Cavallaro A.; Collins S.L.;

Citation:

Obstetrician and Gynaecologist. (no pagination), 2025. Date of Publication: 2025.

Abstract:

Key content: Antenatal imaging is a screening tool integral to ensuring women are cared for in the most appropriate setting. The pretest probability of PAS should be considered before any imaging is performed. PAS is an iatrogenic disease. Any process which disrupts the endometrium increases the risk. Caesarean birth is the most common cause. Specialist placental assessment in asymptomatic women should be offered between 24 and 28 weeks. Ultrasound and MRI have similar diagnostic value, and MRI should only be used as an adjunct following ultrasound assessment by a specialist in placental imaging. Learning objectives: To understand the pathophysiology of PAS. To understand the distinction between screening for and diagnosis of PAS. To increase confidence in the interpretation of sonographic features of PAS. To provide a rationale for PAS care being provided in centres of excellence. Ethical issues: If women increasingly prefer caesarean section over vaginal birth, it is likely that this trend will result in increasing numbers of complex caesarean deliveries and PAS cases. Many studies have shown decreased morbidity and mortality if PAS cases are managed by an experienced multi-disciplinary team (MDT) in a PAS centre of excellence; therefore, accurate screening and timely referral are vital to improve patient care for women with risk factors.

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