Open access

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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Nigeria introduces the world's first Men5 CV meningitis vaccine (2025)

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Type of publication:

Journal article

Author(s):

Aderinto N.; Olatunji G.; Kokori E.; Ogieuhi I.J.; Alao A.E.; Ajimotokan O.I.; Victoria O.O.; *Akinruli O.A.; Olawoyin M.T.

Citation:

Discover public health. 22(1) (no pagination), 2025. Article Number: 194. Date of Publication: 01 Dec 2025

Abstract:

Meningitis is a serious and potentially life-threatening condition due to inflammation of the brain and spinal cord's meninges. It has various etiologies, among which bacterial meningitis appears to be the most prevalent. Nigeria, the largest country in Africa has now become the first country to roll out a new vaccine called the Men5CV, being able to offer protective against five meningococcal bacterial strains (A, C, W, Y, and X), it offers hope to low-income and developing countries across the world. Clinical trials showed consistent efficacy with minimum adverse effects, and as such it has been approved by the World Health Organization (WHO). 1686 suspected cases were recorded within the last four years in Nigeria, with about 124 confirmed deaths. Despite the success with the MenA conjugate vaccine, other strains still persist. Through a 13-year collaborative effort, there has been significant protection. The rollout of the MEN4CV marks a critical step towards the goal of the WHO in completely eradicating meningitis by 2030. Although challenges like religious reasons and limited vaccine supply exist, we believe with effective training for healthcare practitioners and effective distribution of vaccines to remote areas, these obstacles can be overcome.

DOI: 10.1186/s12982-025-00592-9

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Is this Acute Manifestation of Adrenal Crisis? (2025)

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Type of publication:

Journal article

Author(s):

*Nwaneri C.

Citation:

Acta Medica International. 12(1) (pp 66-71), 2025. Date of Publication: 01 Jan 2025.

Abstract:

Adrenal crisis is a life threatening complication of both primary and secondary adrenocortical insufficiency. The diagnosis of adrenal crisis requires a high index of suspicion, such as circulatory collapse, refractory hypotension, and metabolic acidosis. The clinical features are because of both mineralocorticoid and glucocorticoid deficiencies. The primary and initial treatment is intravenous cortisol therapy, and saline (sometimes glucose). Case presentation was used in this 43 year old woman who presented with dizziness, anorexia, vomiting, generalized weakness, and lethargy. She had a history of recent tuberculosis infection and was commenced on antituberculosis therapy, rifampicin. Her biochemical profile was suggestive of impending adrenal crisis. Her chest X ray and computed tomography were grossly normal. The patient recovered completely and was discharged home with the resolution of her deranged metabolic and electrolyte derangements. Appropriate specialist care is vital in patients with adrenal crisis, coupled with initial aggressive fluid resuscitation and acid base balance and good intensive care.

DOI: 10.4103/amit.amit_89_24

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Cognitive impairment (chemobrain) in early breast cancer patients treated with anthracycline/taxane chemotherapy (2025)

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Type of publication:

Conference abstract

Author(s):

Kenny L.; Vicidomini R.; Wardeh S.A.; Riddle P.; *Pettit L.; Gayani P.; Staples E.; McLeavy L.; Kanwar J.; Edison P.

Citation:

ESMO Open. Conference: Abstract Book of the ESMO Breast Cancer Congress 2025. Munich Germany. 10(Supplement 4) (no pagination), 2025. Article Number: 104998. Date of Publication: 01 May 2025.

Abstract:

Background: Chemotherapy-induced cognitive impairment (CICI) occurs in ~33% of post-chemotherapy breast cancer patients, and is associated with transient or enduring cognitive deficits. However, the aetiology and underlying pathophysiology is yet to be determined. Method(s): 270 early breast cancer patients who received anthracycline (AC/EC) and/or taxane chemotherapy within the previous 12 months were enrolled from UK sites. Clinical and neurocognitive tests were performed on an Artificial Intelligence platform. 18 patients with low cognitive scores, along with 19 controls, underwent further in-person neurocognitive assessments and brain MRI(3T) in Imperial College London. MRI images were analysed using Region of Interest (ROI) and Voxel-Based Morphometric (VBM) analysis. Result(s): The mean age of the patients was 55.6 years (controls=66.7) and average time between initiation of chemotherapy and MRI was 14.1 months. 13/18 received AC/EC-taxanes, 2 received TC, and 3 received taxanes. At the time of MRI, most patients had completed cytotoxic therapy, and 89% were undergoing endocrine therapy. ROI and VBM analyses of CICI patients consistently demonstrated significantly lower grey matter volumes (mm3) and surface areas (mm2) in the following regions: cingulate cortex, medial and orbitofrontal regions of the frontal lobe, precuneus and parietal areas, temporal pole, and lingual cortex. This was associated with poorer semantic, verbal fluency and lower MMSE scores in CICI patients. Conclusion(s): This preliminary data reveals significant cerebral morphological changes and cognitive impairment following anthracycline-taxane chemotherapy. This highlights an urgent need to investigate CICI in a larger cohort of patients to evaluate whether chemotherapy could induce neurodegenerative process so that long-term preventative strategies could be developed.

DOI: 10.1016/j.esmoop.2025.104998

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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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Endoscopically Assisted Reconstruction of the Achilles Tendon Using Semitendinosus Graft (2025)

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Type of publication:

Journal article

Author(s):

*Carmont, Michael R; *Saha, Arunansu; *Rhind, John-Henry; Nilsson, Niklas; Karlsson, Jon; Nilsson-Helander, Katarina.

Citation:

Video Journal of Sports Medicine. 1(5):26350254211021859, 2021 Sep-Oct.

Abstract:

Background: Chronic ruptures of the Achilles tendon may lead to symptomatic weakness, despite rehabilitation. Open reconstruction yields good outcome but has a high complication rate, notably wound problems. Endoscopically assisted free semitendinosus transfer restores ankle and preserves first metatarsophalangeal joint (MTPJ) function.

Indications: The main indication for the procedure is symptomatic chronic rupture of the Achilles tendon with a palpable tendon gap.

Technique Description: The procedure can be split into 4 stages: graft harvest, calcaneum and tunnel preparation, proximal graft attachment, and finally graft passage and screw insertion.

Discussion/Conclusion: Following reconstruction, patients use a cast in full plantar flexion for 2 weeks, then a graduated walker for full weight-bearing.

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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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Hyponatraemia Induced by Terlipressin in Patients Diagnosed with Decompensated Liver Cirrhosis and Acute Variceal Bleeding (2025)

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Type of publication:

Journal article

Author(s):

*Elshehawy, Mahmoud; *Panicker, Richel Merin; Abdelgawad, Alaa Amr; Ball, Patrick Anthony; Morrissey, Hana.

Citation:

Medicines. 12(2), 2025 Mar 28.

Abstract:

Background: Hyponatraemia is a rare but potentially life-threatening complication of terlipressin therapy. Case history: In the current case, a 39-year-old female with decompensated liver cirrhosis (Child-Pugh C) and acute variceal bleeding experienced a precipitous decline in serum sodium-from 136 mmol/L to 115 mmol/L-within 48 h of initiating terlipressin therapy. This was accompanied by marked fluid retention, reduced urine output, and symptoms of confusion and agitation. Laboratory tests confirmed dilutional hyponatraemia, characterized by urinary sodium <20 mmol/L and urine osmolality <100 mOsm/kg, indicating excessive free water reabsorption. Outcomes: The prompt discontinuation of terlipressin, fluid restriction and the cautious administration of hypertonic sodium chloride solution (2.7% NaCl) achieved a gradual normalization of sodium levels and resolution of symptoms. Fluid balance monitoring revealed a marked diuretic response following terlipressin cessation. This case aligns with existing reports, emphasizing the dual vasopressin receptor activity of terlipressin and its capacity to induce hyponatraemia, particularly in cirrhotic patients with preserved renal function and higher baseline sodium levels. Conclusions: This case and a literature review underscored the critical need for early fluid balance monitoring to detect retention. This case highlights the importance of individualized risk assessment, multidisciplinary management, and vigilant sodium correction to avoid complications. Practical recommendations are outlined to aid clinicians in the recognition and management of terlipressin-induced hyponatraemia.

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A Comprehensive Review of the Role of UV Radiation in Photoaging Processes Between Different Types of Skin (2025)

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Type of publication:

Journal article

Author(s):

Brar, Gurjasan; Dhaliwal, Anoop; Brar, Anupjot S; Sreedevi, Manasa; *Ahmadi, Yasmin; Irfan, *Muhammad; Golbari, Rebecca; Zumarraga, Daniela; *Yateem, Dana; Lysak, Yuliya; Abarca-Pineda, Yozahandy A.

Citation:

Cureus. 17(3):e81109, 2025 Mar.

Abstract:

Ultraviolet (UV) radiation significantly contributes to photoaging, with its effects varying among different Fitzpatrick skin types. Light skin (Types I-III) has a natural sun protection factor (SPF) of only 3.3, making it particularly vulnerable to DNA damage, collagen degradation, and skin cancer. Darker skin (Types IV-VI) has a natural SPF of 13.4, providing greater photoprotection while elevating the risk of post-inflammatory hyperpigmentation and delaying skin cancer diagnosis. UVA penetrates deep into the dermis, promoting collagen degradation, whereas UVB causes DNA mutations, increasing the risk of cancer. Eumelanin in darker skin mitigates oxidative stress, while pheomelanin in lighter skin functions as a pro-oxidant, increasing vulnerability to photoaging. Although incidence rates are lower, melanoma is identified at more advanced stages in those with darker skin, resulting in poorer outcomes. Protective measures, such as broad-spectrum sunscreens, antioxidants, and hydration, are crucial for all skin types but necessitate customized strategies. Individuals with lighter skin benefit from SPF 50+ and DNA-repairing compounds, whereas those with darker complexion necessitate SPF 30-50 and pigmentation-focused skincare. Comprehending the biological mechanisms and variations in UV damage facilitates the creation of customized photoprotection solutions, enhancing skin health and mitigating long-term UV-related issues for all skin types.

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