Protocol for the IMPART study: IMplementation of the preterm birth surveillance PAthway – a RealisT evaluation

Introduction New guidance, from NHS England (Saving Babies Lives Care Bundle Version 2 Element 5 (SBLCBv2)) has recommended a best practice pathway for women at risk of preterm birth (the Preterm Birth Pathway). This is to help meet the Department of Health’s aim to reduce preterm birth from 8% to 6% by 2025. Considering most hospitals do not currently have a preterm prevention clinic, implementing this pathway will require significant coordination. Methods and analysis The study will aim to investigate key features of contexts, mechanisms and outcomes, and their interactions in the implementation of the asymptomatic prediction and prevention components of the SBLCBv2 Preterm Birth Surveillance Pathway. This will be through a theory driven realist evaluation, utilising mixed methods (interviews with staff and women, observational analysis and analysing routinely collected hospital and admin data) in three case sites in England. The study has a Project Advisory Group composed of five women who have recently given birth. Ethics and dissemination The study has ethical approval (King’s College London REC approval number: MRSP-20/21-20955, and, IRAS:289144). A dissemination plan will be fully created with the Project Advisory Group, and we anticipate this will include presenting at conferences, publications, webinars, alongside dissemination to the wider population through parent and baby groups, the media and charities. Trial registration number ISRCTN57127874

Developing shared understanding of pre-eclampsia in Haiti and Zimbabwe using Theory of Change

Pre-eclampsia, a complex and multi-system disorder specific to pregnancy, is a leading cause of preventable maternal and perinatal deaths in low-resource settings. Early detection and appropriate intervention with management of hypertension, prevention of eclampsia and timely delivery are effective at reducing mortality and morbidity. Outcomes can be greatly improved with the provision and uptake of good quality care. Cultural contexts of maternal care, social practices and expectations around pregnancy and childbirth profoundly shape understanding and prioritisation when it comes to seeking out care. Few studies have addressed health education specifically targeting pre-eclampsia in low resource settings. The existing literature has limited descriptions of contextual barriers to care or of the intervention development processes employed. More engaging, holistic approaches to pre-eclampsia education for women and families that recognise the challenges they face and that support a shared understanding of the disorder, are needed. We describe our experience of developing a Theory of Change (ToC) as part of the co-production of educational resources for pre-eclampsia in Haiti and Zimbabwe

Experiences of Impacted Foetal Head: Findings from a Pragmatic Focus Group Study of Mothers and Midwives.

IntroductionWe aimed to explore the lived experiences of caesarean birth complicated by impaction of the foetal head, for mothers and midwives.MethodsA pragmatic, qualitative, focus group study of mixed-participants was conducted, face-to-face. They were postpartum women (n = 4), midwives (n = 4), and a postpartum midwife (n = 1) who had experience of either providing care for impacted foetal head, and/or had experienced it during their own labour, in Fife, United Kingdom. Data were transcribed and were analysed using template analysis.ResultsThree main themes emerged through analysis: (i) current knowledge of impacted foetal head; (ii) current management of impacted foetal head; and (iii) experiences and outcomes of impacted foetal head. Each theme was made up of various initial codes when data were analysed inductively. Finally, each theme could be overlaid onto the three core principles of the Tydeman Tube: (1) to improve outcomes for mother and baby in the second stage of labour; (2) to reduce the risk of trauma to mother and baby in complicated births; and (3) to increase respectful care for women in labour; thus allowing for a neat analytic template.ConclusionA lack of consensus regarding definition, management, and training were highlighted by the midwives. Women anticipated caesarean birth in late labour as straightforward and were therefore unaware of this potential complication. Women and midwives would welcome any new device to facilitate delivery of the impacted foetal head (IFH) as long as it is fully evaluated prior to widespread introduction. Women were not averse to being part of this evaluation process

Vaginal micronised progesterone for the prevention of hypertensive disorders of pregnancy : A systematic review and meta-analysis

ACKNOWLEDGEMENTS The investigators thank all trial authors who provided information about their own studies, including Zarko Alfirevic, Ana Luisa Areia, Camil Castelo-Branco, Ozlem Erdem, Fabio Facchinetti, Luke McLindon, Ben Willem Mol, Kypros Nicolaides and Ariel Weissman.Peer reviewe

How are hospitals in England caring for women at risk of preterm birth in 2021? The influence of national guidance on preterm birth care in England: a national questionnaire

Background National guidance (Saving Babies Lives Care Bundle Version 2 (SBLCBv2) Element 5) was published in 2019, with the aim to standardise preterm care in England. We plan to identify how many preterm birth surveillance clinics there are in England, and to define current national management in caring for women who are both asymptomatic and high-risk of preterm birth, and who arrive symptomatically in threatened preterm labour, to assist preterm management both nationally and internationally. Methods An online survey comprising of 27 questions was sent to all maternity units in England between February 2021 to July 2021. Results Data was obtained from 96 units. Quantitative analysis and free text analysis was then undertaken. We identified 78 preterm birth surveillance clinics in England, an increase from 30 preterm clinics in 2017. This is a staggering 160% increase in 4 years. SBLCBv2 has had a considerable impact in increasing preterm birth surveillance clinic services, with the majority (61%) of sites reporting that the NHS England publication influenced their unit in setting up their clinic. Variations exist at every step of the preterm pathway, such as deciding which risk factors warrant referral, distinguishing within particular risk factors, and offering screening tests and treatment options. Conclusions While variations in care still do persist, hospitals have done well to increase preterm surveillance clinics, under the difficult circumstances of the COVID pandemic and many without specific additional funding

The incidence of pregnancy hypertension in India, Pakistan, Mozambique, and Nigeria: A prospective population-level analysis.

Background: Most pregnancy hypertension estimates in less-developed countries are from cross-sectional hospital surveys and are considered overestimates. We estimated population-based rates by standardised methods in 27 intervention clusters of the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials. Methods and findings: CLIP-eligible pregnant women identified in their homes or local primary health centres (2013–2017). Included here are women who had delivered by trial end and received a visit from a community health worker trained to provide supplementary hypertension-oriented care, including standardised blood pressure (BP) measurement. Hypertension (BP ≥ 140/90 mm Hg) was defined as chronic (first detected at \u3c20 weeks gestation) or gestational (≥20 weeks); pre-eclampsia was gestational hypertension plus proteinuria or a pre-eclampsia-defining complication. A multi-level regression model compared hypertension rates and types between countries (p \u3c 0.05 considered significant). In 28,420 pregnancies studied, women were usually young (median age 23–28 years), parous (53.7%–77.3%), with singletons (≥97.5%), and enrolled at a median gestational age of 10.4 (India) to 25.9 weeks (Mozambique). Basic education varied (22.8% in Pakistan to 57.9% in India). Pregnancy hypertension incidence was lower in Pakistan (9.3%) than India (10.3%), Mozambique (10.9%), or Nigeria (10.2%) (p = 0.001). Most hypertension was diastolic only (46.4% in India, 72.7% in Pakistan, 61.3% in Mozambique, and 63.3% in Nigeria). At first presentation with elevated BP, gestational hypertension was most common diagnosis (particularly in Mozambique [8.4%] versus India [6.9%], Pakistan [6.5%], and Nigeria [7.1%]; p \u3c 0.001), followed by pre-eclampsia (India [3.8%], Nigeria [3.0%], Pakistan [2.4%], and Mozambique [2.3%]; p \u3c 0.001) and chronic hypertension (especially in Mozambique [2.5%] and Nigeria [2.8%], compared with India [1.2%] and Pakistan [1.5%]; p \u3c 0.001). Inclusion of additional diagnoses of hypertension and related complications, from household surveys or facility record review (unavailable in Nigeria), revealed higher hypertension incidence: 14.0% in India, 11.6% in Pakistan, and 16.8% in Mozambique; eclampsia was rare (\u3c0.5%). Conclusions: Pregnancy hypertension is common in less-developed settings. Most women in this study presented with gestational hypertension amenable to surveillance and timed delivery to improve outcome

Longitudinal change in cervical length following vaginal or abdominal cervical cerclage: a randomized comparison

BACKGROUND: Cervical cerclage has been shown to reduce the risk of recurrent spontaneous preterm birth in a high-risk patient population; however, the mechanism is not well understood. Transabdominal cerclage is superior to low and high vaginal cerclage in reducing early spontaneous preterm birth and fetal loss in women with previous failed vaginal cerclage. Cervical length measurements are commonly used to monitor high-risk women and may explain the mechanism of success. OBJECTIVE: This study aimed to evaluate the rate of change in longitudinal cervical length after randomized placement of low transvaginal, high transvaginal, or transabdominal cerclage in women with a previous failed vaginal cerclage. STUDY DESIGN: This was a planned analysis of longitudinal transvaginal ultrasound cervical length measurements from patients enrolled in the Vaginal Randomised Intervention of Cerclage trial, a randomized controlled trial comparing transabdominal cerclage or high transvaginal cerclage with low transvaginal cerclage. Cervical length measurements at specific gestational ages were compared over time and between groups, using generalized estimating equations fitted using the maximum-likelihood random-effects estimator. In addition, cervical length measurements were compared in women with transabdominal cerclage placed before and during pregnancy. The diagnostic accuracy of cervical length as a predictor of spontaneous preterm birth at <32 weeks of gestation was explored. RESULTS: This study included 78 women who underwent longitudinal cervical length assessment (70% of the analyzed cohort) with a history of failed cerclage, of whom 25 (32%) were randomized to low transvaginal cerclage, 26 (33%) to high transvaginal cerclage, and 27 (35%) to transabdominal cerclage. Abdominal cerclage was superior to low (P=.008) and high (P=.001) vaginal cerclage at maintaining cervical length over the surveillance period (14 to 26 weeks of gestation) (+0.08 mm/week, 95% confidence interval, -0.40 to 0.22; P=.580). On average, the cervical length was 1.8 mm longer by the end of the 12-week surveillance period in women with transabdominal cerclage (+1.8 mm; 95% confidence interval, -7.89 to 4.30; P=.564). High vaginal cerclage was no better than low cervical cerclage in the prevention of cervical shortening; the cervix shortened by 13.2 mm over 12 weeks in those with low vaginal cerclage (95% confidence interval, -21.7 to -4.7; P=.002) and by 20 mm over 12 weeks in those with high vaginal cerclage (95% confidence interval, -33.1 to -7.4; P=.002). Preconception transabdominal cerclage resulted in a longer cervix than those performed during pregnancy; this difference was significant after 22 weeks of gestation (48.5 mm vs 39.6 mm; P=.039). Overall, cervical length was an excellent predictor of spontaneous preterm birth at <32 weeks of gestation (receiver operating characteristic curve, 0.92; 95% confidence interval, 0.82-1.00). CONCLUSION: In women with a previous failed cervical cerclage, in the next pregnancy, the cervical length in women treated with vaginal cerclage funneled and shortened over time, whereas there was preservation of cervical length in women who receive transabdominal cerclage. Cervical length remained longer in transabdominal procedures performed before pregnancy than in transabdominal procedures performed during pregnancy. Overall, cervical length was an excellent predictor of spontaneous preterm birth in our cohort. Our findings may explain the mechanism of benefit for transabdominal cerclage, with its high placement better maintaining the structural integrity of the cervix at the level of the internal os