Oral Presentations

IMplementation of the Preterm Birth Surveillance PAthway: a RealisT evaluation (The IMPART Study)

259

Authors

Ms Naomi Carlisle, Dr Sonia Dalkin, Prof Andrew H Shennan & Prof Jane Sandall

Presented by

Naomi Carlisle

Affiliations

Ms Naomi Carlisle, Prof Andrew H Shennan & Prof Jane Sandall: Department of Women and Children’s Health, The School of Life Course & Population Sciences, King’s College London, 10th Floor North Wing, St Thomas’ Hospital, Westminster Bridge Road, SE1 7EH, United Kingdom Dr Sonia Dalkin: Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK

Introduction

In the UK, 7.6% of babies are born preterm, which the Department of Health aims to decrease to 6% by 2025. To advance this, NHS England released Saving Babies Lives Care Bundle Version 2 Element 5, recommending the Preterm Birth Pathway for women at risk of preterm birth. The success of this new pathway depends on its implementation. The IMPART study aimed to research how, why, for whom, to what extent and in what contexts the prediction and prevention aspects of Preterm Birth Surveillance Pathway is implemented.

Methods

A realist evaluation was undertaken. Initial programme theories were developed through a realist informed literature scope, interviews with developers of the NHS England guidance, and a national questionnaire of current practice (Carlisle et al., 2023). Data (interviews and observations with staff and women) were undertaken in 3 case sites in England to ‘test’ the programme theories.

Results

Three explanatory areas were developed: risk assessing and referral; the preterm birth surveillance clinic; and women centred care.

Explanatory area 1 highlighted how risk assessment and referral could be undertaken incorrectly due to a lack of knowledge of preterm birth risk factors, a lack of knowledge on the purpose of the pathway or because practical difficulties prevent easy and appropriate referral.

Explanatory area 2 focused on how once a correct referral has been made to a preterm clinic, knowledgeable and supported clinicians can deliver a well-functioning clinic. If there is a core group of multidisciplinary preterm specialists, they can develop concentrated knowledge and expertise. Nuanced and individualised care could be missing if transvaginal cervical length scans were not undertaken by the specialist preterm team. If sites work together with their local network, resources and support provided can reduce variations of care.

Explanatory area 3 concentrated on how the pathway delivers appropriate care to women. A multidisciplinary preterm team can provide individualised continuity of care, where clinicians are aware and attentive of a woman’s history, yet ensuring ordinary aspects of their pregnancy are not overshadowed.

Conclusion

The IMPART study provides several areas where implementation could be improved. These include educating clinicians on risk factors and the purpose of the preterm clinic, having a specialist multidisciplinary team, and sites actively working with their local network. This multidisciplinary preterm team are then placed to deliver continuity of care for women at high-risk of preterm birth, being attentive to their history but also ensuring they are not defined by their risk status.

Cervical Shortening and Spontaneous Preterm Birth are Associated With Cervical Neutrophil Migration and Complement Activation

272

Authors

Belen Gimeno-Molina1,2,3, Erna Bayar1,2,3, Katherine E Mountain1,2,3, Ryan L Love1,2, Anna V Merrick2, Sanaa Riani-El-Achhab2, Yun S Lee1,2, Ingrid Muller2,4, Anna L David5, Vasso Terzidou1,2,6, Phillip R Bennett1,2, David A MacIntyre1,2, Marina Botto2,7, Pascale Kropf2,4, Lynne Sykes1,2,3,8

Presented by

Belen Gimeno-Molina

Affiliations

1Imperial College Parturition Research Group, Institute of Reproductive and Developmental Biology, Department of Metabolism, Digestion and Reproduction, Imperial College London, UK 2March of Dimes Prematurity Research Centre at Imperial College London, UK 3The Parasol Foundation Centre for Women’s Health and Cancer Research, London, UK 4Department of Infectious Disease, Imperial College London, UK 5Elizabeth Garrett Anderson Institute for Women’s Health, University College London, UK 6Chelsea & Westminster Hospital, Imperial College Healthcare NHS Trust 7Deparment of Immunology and Inflammation, Imperial College London, UK 8St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UK

Introduction

Cervical shortening (CxS) during pregnancy and spontaneous preterm birth (sPTB) are associated with depletion of vaginal Lactobacillus species and increased bacterial diversity. However, the mechanisms by which vaginal microbiota mediate host immune inflammatory responses and modulates the risk of CxS and sPTB are unclear. In this study, we investigated the role of the complement system and neutrophils at the cervicovaginal interface in response to vaginal microbiota, CxS and sPTB.

Methods

Cervicovaginal fluid (CVF) (n=51) was collected across pregnancy (at 12-16 weeks and 20-24 weeks of gestation) from women at high-risk of delivering preterm to assess microbial composition by metataxonomics profiling; cytokines, complement proteins and matrix metalloproteinases (MMPs) were analysed with Luminex multiplex immunoassays. Matched cytobrush and peripheral blood (n=98) were assessed by Aurora CytekTM.

Results

Women who experienced CxS (n=11/51) and women who delivered preterm (n=17/51) were more likely to have a Community State Type (CST) III or CST IV vaginal dominance. Lactobacillus depletion (CST IV) was significantly associated with increased concentrations of complement proteins, compared to L. crispatus (CST I). Both CxS and sPTB were associated with increased concentrations of complement proteins (C1q, C4, C3a, C3b, Factor B, Factor H, Factor I, all p<0.05), as well as matrix metalloproteinases involved in tissue remodelling (MMP-2, MMP-8, MMP-9). There was a higher proportion of women with neutrophils present in association with high-risk microbial compositions and cervical shortening (p<0.05). Furthermore, cervical neutrophils from women with CST IV microbial compositions had an increased expression of CD63 (p=0.0012) and CD66b (p=0.0049) compared to CST I. Finally, higher proportion of cervical neutrophils was associated with an increased local inflammatory response, with increase CVF levels of C3a (p=0.0072), C3b (p=0.0013), IL-8 (p=0.0386) and MMP-8 (p=0.0362).

Conclusion

Microbial-driven CxS and sPTB are likely driven by local immune activation involving neutrophils and complement activation. We present mechanistic insight to support the potential of complement therapeutics in sPTB prevention.

The Sands Listening Project: learning from Black and Asian bereaved parents’ experiences of midtrimester pregnancy loss

290

Authors

Ben Wills, Mehali Patel, Julia Clark

Presented by

Ben Wills

Affiliations

Sands

Introduction

Data comparing outcomes for different ethnic groups in the UK show that Black and Asian babies are more likely to be stillborn or die in the neonatal period compared to white babies. The lack of systematic counting and reporting of miscarriages conceals the full picture of pregnancy loss across the UK. However, compared to white women, Black women are more likely to experience miscarriage, and Black and Asian women are more likely to experience health conditions that can increase the risk of pregnancy complications, including miscarriage. Perinatal mortality rates among babies from Black and Asian backgrounds remain persistently higher and slowest to improve. The perspectives of Black and Asian bereaved parents are critical opportunities to learn about how maternity and neonatal care can be made safer and more equitable at every stage.

Methods

Between March and September 2023, we used focus groups and interviews to gather in-depth data about the care experiences of Black and Asian bereaved parents whose babies died during pregnancy or within 28 days of the birth since 2017. Anonymised transcripts were generated and read line-by-line and phrase-by-phrase to construct analytic codes and categories that linked closely to participants’ accounts. NVivo software was used to help manage the data and analytic processes. By focusing on more recent experiences, we aimed to learn about what care is like in the UK today.

Results

Of the 56 participants, 11 mothers had experienced the death of their baby between 14 and 24 gestational weeks (9 had experienced pregnancy loss and 2 the death of their baby or babies shortly after the birth). They described a range of safety issues relating to: their concerns being dismissed; fragmented and impersonal care; poor communication around safety and risk; and missed opportunities to learn following the death of their baby or babies. Some participants believed they had received poorer care or negative treatment from healthcare professionals because of their ethnicity.

Conclusion

This project helps us understand how systemic issues, along with poor practice and discrimination from some healthcare professionals, may lead to less safe care, with devastating consequences for some Black and Asian families. It is vital that healthcare staff listen to Black and Asian parents and take their concerns seriously. Concerted effort and targeted action are needed across Government, NHS and other key organisations to make care safer and more equitable in order to save Black and Asian babies’ lives.

Effective and simple interventions to improve outcomes for preterm babies worldwide: The FIGO PremPrep-5 initiative.

303

Authors

Megan Hall1, Catalina M. Valencia2,3, Priya Soma-Pillay4, Karen Luyt 5,6, Bo Jacobsson7,8,9, Andrew Shennan1

Presented by

Megan Hall

Affiliations

1 Department of Women and Children’s Health, St Thomas’ Hospital, King’s College London, United Kingdom 2 Department of Obstetrics and Gynaecology, Universidad CES, Medellín, Colombia 3 Maternal Fetal Medicine Unit, Clinica del Prado, Medellín, Colombia 4 Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Pretoria, South Africa and Steve Biko Academic Hospital 5 Bristol Medical School, University of Bristol, Bristol, United Kingdom 6 Neonatology, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom 7 Department of Obstetrics and Gynaecology, , Sahlgrenska University Hospital, Gothenburg, Sweden 8 Department of Obstetrics and Gynaecology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sweden 9 Department of Genetics and Bioinformatics, Domain of Health Data and Digitalization, Institute of Public Health, Oslo, Norway

Introduction

Preterm birth remains the leading cause of mortality among under 5’s and is a major contributor to reduction in quality-of-life adjusted years and reduction in human capital. Over 80% of the burden of preterm birth lies with low- and middle-income countries. Globally, there are many interventions and care bundles that aim to reduce the impact of preterm birth once preterm labour has ensued and into the neonatal period; not all of these are applicable in all settings. We introduces the FIGO PremPrep-5 initiative which aims to disseminate key information on the most simple and effective interventions with the aim of increasing implementation globally.

Methods

A literature review was carried out to summarise evidence for the bundle’s components and considerations specific to their integration to low- and middle-income settings. An educational animation and infographic were created.

Results

Prior to delivery we recommend a course of antenatal corticosteroids, and intrapartum magnesium sulphate; at delivery we recommend delayed cord clamping; postnatally we recommend early feeding with breastmilk and immediate kangaroo care. While there are many other interventions that may improve outcomes at the time of labour and following preterm birth, these are clinically effective and relatively inexpensive options that can be practiced in most settings and supplemented with more advanced care. We include examples of a training video and infographics that will be used for dissemination.

Conclusion

Adherence to simple but evidence-based interventions known to reduce morbidity and mortality associated with preterm birth may contribute to improved outcomes globally.

Evaluation of Preterm birth clinics across the North East & North Cumbria Region

305

Authors

Catherine McParlin 1,2, Stephen C. Robson 1, Alex Patience 3, Julia Wood 4, Judith Rankin 1

Presented by

Catherine McParlin

Affiliations

1= Population and Health Science Institute, Newcastle University 2= Faculty of Health and Life Sciences, Northumbria University 3= Newcastle upon Tyne Hospitals NHS Trust 4= Health Innovation North East and North Cumbria

Introduction

In 2021 the North East/North Cumbria (NENC) Local Maternity and Neonatal System (LMNS), in collaboration with the NENC Preterm birth (PTB) Clinical Leadership Group, funded ten maternity providers in the region to implement PTB clinics at each site. This service would include specialised consultant obstetric, midwifery and sonography support and incorporate updated regional guidelines for the prediction and prevention of PTB.

During 2022-24, a team from Newcastle University is carrying out an evaluation of these services.

Methods

It was envisaged that all PTB clinics would be up and running by April 2022 with the capacity to carry out cervical length measurements. Lead consultants for all 10 Units were identified prior to April 2022. Whilst some Units had a specialist midwife in post by April/May, the final two commenced 6 months later than anticipated.

A clinic data collection dashboard was designed by the LMNS PTB group comprising of variables to be collected by the local clinic teams.

Results

During 2022/23, 1863 pregnant women attended the PTB NENC clinics, of whom 1682 (90.3%) commenced the PTB pathway, equating to 5.3% of all women booking for pregnancy care during this period. Of these women, 16.9% were known to be smokers and 43.5% were deemed to be at high risk of PTB (56.5% intermediate risk).

Between 16-24 weeks gestation, 135 women (8.0%) were found to have a cervix less than 25mm in length, 153 women (9.1%) were treated with progesterone pessaries and 85 (5.0%) underwent cervical cerclage. Six women declined any intervention.

During the same period, 627 pregnant women delivered before 34 weeks gestation across the whole NENC region, equating to 2.5% of total deliveries, a large proportion of these for iatrogenic reasons.

Conclusion

All 10 Units were able to initiate a PTB clinic and deliver regional guidelines as planned. Some units were impacted by staffing and building capacity to perform cervical length scans but this was rectified within 6 months. Capacity within Units to carry out cervical length scans has increased, mainly due to training offered Regionally.

The data collection dashboard evolved throughout the year as the PTB group identified additional key variables, therefore next year’s data will provide more detailed information on issues such as reasons for PTB (spontaneous versus iatrogenic), inequalities and disparities across the Region, smoking rates at delivery and ethnicity.

Whilst there is a need for improvement, anecdotally an increased awareness of PTB and optimisation measures has been noted within each Unit.

A randomised controlled trial of an information package on cervical cerclage technique

313

Authors

Laura Stirrat(1,2), Megan Hall(3), Natalie Suff(3), Hannah Rosen O’Sullivan(3), Nicola Moriarty(3), Graham Tydeman(4), Andrew Shennan(3)

Presented by

Laura Stirrat

Affiliations

1. Simspon Centre for Reproductive Health, Royal Infirmary of Edinburgh 2. Centre for Cardiovascular Sciences, University of Edinburgh 3. Department of Women and Children’s Health, St Thomas’ Hospital, King’s College London 4. Victoria Hospital Kirkcaldy, NHS Fife

Introduction

Transcervical cerclage is commonly performed to prevent preterm birth but despite its widespread use, the mechanism of action of cerclage is unclear and there is little research on the optimal technique.

Using a simulator that we developed and evaluated, and computerised tomography (CT) imaging, we previously demonstrated considerable variation in cerclage placement amongst UK experts. This may result in variable efficacy of the procedure and may impact outcomes in clinical trials of cerclage.

We aimed to evaluate an information package that may help standardise cerclage technique on a simulator and to compare cerclage technique in Obstetricians attending a European Conference with UK experts in our previous study.

Methods

We took a cervical cerclage simulator to a European Preterm Birth Conference in September 2023. The simulator (Cervical Cerclage Module – PROMPT Flex; Limbs&Things Ltd) consists of a realistic female pelvis and vagina with a replaceable cervix, which standardises the anatomy for each participant.

We randomised participants into two groups; the first were asked to perform their usual cerclage and the second were given an information package with findings from our previous simulator study of cerclage technique and a video demonstrating of using the simulator, prior to performing cerclage. Each sutured cervix was removed from the simulator following the procedure and stored anonymously. Conference attendees were informed about the study before the conference and were invited to bring their preferred suture or select from range of suture type and needle sizes were also available. We assessed suture height, number of bites, knot site and free thread length from the sutured model cervices. Using CT imaging, depth of suture and tension (by reduction in area of cervix) were assessed.

Results

In the UK cohort 52 cervical cerclages were completed. Mean suture height was 33mm (standard deviation, 7.7mm), greater with monofilament suture than with Mersilene tape, and associated with smaller needle size. Mean depth of bite and mean reduction of starting area did not differ by suture type.

In September 2023, 57 clinicians were recruited and randomised. The analysis for this comparison is currently in progress and will examine whether cerclage technique differs based on choice of suture material or exposure to the information package.

Conclusion

Our previous study demonstrated a wide variation in suture technique between UK experts. The results from the European comparison will be presented at the conference.

First presentation of findings of complete dataset from UKOSS prospective study investigating Pregnancy Outcomes Following Bone Marrow Transplantation, with or without Total Body Irradiation

322

Authors

Dr K Birchenall(1,2), Professor A David (3, 4), Dr M Davies (5), Dr V Grandage (5), Professor M Knight (6) & Dr M Griffin (1,2).

Presented by

Katherine Birchenall

Affiliations

1. University Hospitals Bristol and Weston NHS Foundation Trust; 2. University of Bristol 3. Elizabeth Garrett Anderson Institute for Women’s Health, University College London, London, UK 4. National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre 5. University College London Hospitals NHS Foundation Trust; 6. UKOSS;

Introduction

Female childhood cancer survivors have an increased risk for adverse pregnancy outcomes, including preterm birth (PTB). However, relatively little is known about pregnancy outcomes specifically for women treated with bone marrow transplant (BMT) +/- total body irradiation (TBI), and management is likely variable across the UK. Preconception counselling and early referral to high-risk PTB prevention clinics (PTBPC) may improve outcomes. The UK Obstetric Surveillance System (UKOSS) was developed to investigate uncommon disorders of pregnancy.

We are jointly funded by Action Medical Research/Borne to determine the incidence of adverse pregnancy outcomes for these women in the UK.

Methods

Design:

Prospective observational study.

Method:

Pregnant women with a history of BMT +/- TBI were identified through the UKOSS between 1st January 2020 and 31st December 2022 (included a 12-month extension due to the pandemic). Data was submitted via data collection forms by UKOSS reporters local to nationwide (UK) consultant-led maternity units. Data collection has just closed on 31.10.2023 and we have commenced data analysis now.

Results

36 pregnancies were reported over the two years. For the first time, we will present the findings from our full dataset at Conference, including detailed reporting of treatment received, antenatal course, and pregnancy outcomes; with any associations found between certain cancer treatments and pregnancy outcomes, gestational age at birth, and any increased frequency of interventions required during pregnancy.

Conclusion

The findings of this study will enable better information provision at the time of cancer treatment and during preconception counselling for those requiring BMT +/- TBI, and will contribute to recommendations for optimal pregnancy care for this group.

Is spontaneous preterm birth risk subsequent to a term emergency caesarean associated with length of labour? – interim analysis of prospective data

323

Authors

Glazewska-Hallin A, Rosen O’Sullivan H, Story L, Suff N, Carter J, Shennan AH

Presented by

Agnieszka Glazewska-Hallin

Affiliations

1. Department of Women’s and Children’s Health, St Thomas’ Hospital, King’s College London, London, UK 2. Centre for the Developing Brain, King’s College, London, London, UK

Introduction

Emergency caesarean section (EMCS) especially at full dilatation (FDCS) causes cervical caesarean damage (CCD) and is associated with an increased subsequent risk of spontaneous preterm birth (sPTB). The aetiology is unclear but may be related to obstructed labour and/or cervical trauma. Our study of prospective data analyses the relationship between length of labour prior to EMCS and sPTB risk.

Methods

CRAFT is a prospective study of sPTB risk following in labour term EMCS of singleton pregnant women at 47 sites in United Kingdom. We conducted an interim analysis of 6497 delivered women with completed outcomes. Our focus was comparing women with a sPTB (24-36+6 weeks’ gestation) and term (>37 weeks’ gestation) delivery subsequent to EMCS, the proportion with and without a FDCS history and their length of labour (defined as time from examination confirming established labour (³4cm) to time of delivery). Our control cohort is women with only a term vaginal delivery history from 15 sites (69081 women).

The primary outcome is sPTB <37 weeks gestation. Secondary outcomes include adverse perinatal outcome, interventions such as progesterone and cerclage, delivery <34 weeks, late miscarriage and other maternal or fetal morbidities. We adjusted for sPTB risk factors through logistic regression (age, BMI, ethnicity, smoking, parity, previous sPTB gestation/late miscarriage, uterine anomaly and cervical surgery).

Results

sPTB was similar in 185/4149 (4%) of women with a previous term EMCS (4-9cm dilated) and 115/2348 (5%) of women with a previous term FDCS (aOR 1.1035 (95% CI 0.8694 – 1.4007), p=0.4182). There was no difference in length of labour between those with term and preterm outcomes (652.5mins vs 551.5mins, p=0.3015). In our control group the rate of sPTB was 2662/69081 (3.9%) compared to EMCS 300/6497 (4.6%) at any dilatation (aOR 1.2079 (95% CI 1.0690 to 1.3648), p = 0.0024).

Conclusion

This data shows that length of labour is not an independent risk factor for CCD. This suggests a mechanism of cervical trauma from incision itself or resulting cervical extensions and warrants further analysis in our CRAFT cohort. Interestingly, an EMCS has a similar increased sPTB risk to FDCS when compared to women with no caesarean history.