Recent Submissions

  • Role of early management of hyperornithinaemia-hyperammonaemia-homocitrullinuria syndrome in pregnancy

    Billingham, Matthew James; Rizk, Rania; Rizk, Rania; Obstetrics and Gynaecology; Medical and Dental; University Hospitals Birmingham NHS Foundation Trust (BMJ Publishing Group, 2021-07-01)
    Hyperornithinaemia-hyperammonaemia-homocitrullinuria (HHH) syndrome is a rare inherited metabolic disorder of the urea cycle. Few reports exist to guide practices during pregnancy and fetal delivery. Yet, with affected patients often surviving into reproductive age, appropriate management of the peripartum phase is essential to ensure positive maternal and fetal outcomes.Reassuringly, the vast majority of offspring of parturients with HHH syndrome have normal developmental outcomes; yet as seen here, fetal growth restriction does appear more frequently. Furthermore, in addition to the absent fetal corpus callosum observed in this case, other fetal cerebral abnormalities, including speech delay and intellectual impairment, have been recognised.Unregulated dietary intake is one proposed factor for the observed disruption in fetal growth and early cerebral development. These stipulations not only reinforce the importance of extensive planning and teamwork, but also demonstrate the importance of timely intervention by a metabolic dietician and dietary compliance in the early organogenesis stage of pregnancy.
  • Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study

    Daniels, Jane P; Dixon, Emily; Gill, Alicia; Bishop, Jon; Wilks, Mark; Millar, Michael; Gray, Jim; Roberts, Tracy E; Plumb, Jane; Deeks, Jonathan J; et al. (BioMed Central, 2022-01-14)
    Background: Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-of-care rapid intrapartum test to detect maternal GBS colonisation reduces maternal antibiotic exposure compared with usual care, where antibiotics are administered due to those risk factors. We assessed the accuracy of the rapid test in diagnosing maternal GBS colonisation, against the reference standard of selective enrichment culture. Methods: We undertook a parallel-group cluster randomised trial, with nested test accuracy study and microbiological sub-study. UK maternity units were randomised to a strategy of rapid test (GeneXpert GBS system, Cepheid) or usual care. Within units assigned to rapid testing, vaginal-rectal swabs were taken from women with risk factors for vertical GBS transmission in established term labour. The trial primary outcome was the proportion of women receiving intrapartum antibiotics to prevent neonatal early-onset GBS infection. The accuracy of the rapid test was compared against the standard of selective enrichment culture in diagnosing maternal GBS colonisation. Antibiotic resistance profiles were determined in paired maternal and infant samples. Results: Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units; 906 mothers (951 babies) were in usual care units. There was no evidence of a difference in the rates of intrapartum antibiotic prophylaxis (relative risk 1.16, 95% CI 0.83 to 1.64) between the rapid test (41%, 297/716) and usual care (36%, 328/906) units. No serious adverse events were reported. The sensitivity and specificity measures of the rapid test were 86% (95% CI 81 to 91%) and 89% (95% CI 85 to 92%), respectively. Babies born to mothers who carried antibiotic-resistant Escherichia coli were more likely to be colonised with antibiotic-resistant strains than those born to mothers with antibiotic-susceptible E. coli. Conclusion: The use of intrapartum rapid test to diagnose maternal GBS colonisation did not reduce the rates of antibiotics administered for preventing neonatal early-onset GBS infection than usual care, although with considerable uncertainty. The accuracy of the rapid test is within acceptable limits. Trial registration: ISRCTN74746075 . Prospectively registered on 16 April 2015
  • Are trainees working in obstetrics and gynecology confident and competent in the care of frail gynecological oncology patients?

    Owens, Gemma Louise; Sivalingam, Vanitha; Abdelrahman, Mohamed; Beirne, James P; Blake, Dominic; Collins, Anna; Davies, Rhianna; Dilley, James; Farquharson, Malcolm; Frimpong, Diana; et al. (BMJ Publishing Group, 2020-10-12)
    Introduction: Older patients undergoing cancer surgery are at increased risk of post-operative complications, prolonged hospital stay, and mortality. Identification of frailty can help predict patients at high risk of peri-operative complications and allow a collaborative, multidisciplinary team approach to their care. A survey was conducted to assess the confidence and knowledge of trainees in obstetrics and gynecology regarding identification and management of peri-operative issues encountered in frail gynecological oncology patients. Methods: A web-based survey was distributed via the Audit and Research in Gynaecological Oncology (ARGO) collaborative and UK Audit and Research Collaborative in Obstetrics and Gynaecology (UKARCOG) . The survey on the management of frail peri-operative patients was disseminated to doctors-in-training (trainees) working in obstetrics and gynecology in the United Kingdom (UK) and Ireland. Specialty (ST1-7), subspecialty, and general practice trainees, non-training grade doctors, and foundation year doctors currently working in obstetrics and gynecology were eligible. Consultants were excluded. Study data were collected using REDCAP software hosted at the University of Manchester. Responses were collected over a 6-week period between January and February 2020. Results: Of the 666 trainees who participated, 67% (425/666) reported inadequate training in peri-operative management of frail patients. Validated frailty assessment tools were used by only 9% (59/638) of trainees and less than 1% (4/613) were able to correctly identify all the diagnostic features of frailty. Common misconceptions included the use of chronological age and gender in frailty assessments. The majority of trainees (76.5%, 448/586) correctly answered a series of questions relating to mental capacity; however, only 6% (36/606) were able to correctly identify all three diagnostic features of delirium. A total of 87% (495/571) of trainees supported closer collaboration with geriatricians and a multidisciplinary approach. Conclusions: Obstetrics and gynecology trainees reported inadequate training in the peri-operative care of frail gynecological oncology patients, and overwhelmingly favored input from geriatricians. Routine use of validated frailty assessment tools may aid diagnosis of frailty in the peri-operative setting. There is an unmet need for formal education in the management of frail surgical patients within the UK and Irish obstetrics and gynecology curriculum.
  • The impact of COVID-19 on the wellbeing of the UK nursing and midwifery workforce during the first pandemic wave: a longitudinal survey study

    Couper, Keith; Murrells, Trevor; Sanders, Julie; Anderson, Janet E; Blake, Holly; Kelly, Daniel; Kent, Bridie; Maben, Jill; Rafferty, Anne Marie; Taylor, Rachel M; et al. (Pergamon Press, 2021-12-15)
    Background: The specific challenges experienced by the nursing and midwifery workforce in previous pandemics have exacerbated pre-existing professional and personal challenges, and triggered new issues. We aimed to determine the psychological impact of the COVID-19 pandemic on the UK nursing and midwifery workforce and identify potential factors associated with signs of post-traumatic stress disorder. Methods: A United Kingdom national online survey was conducted at three time-points during the first wave of the COVID-19 pandemic between April and August 2020 (T1 and T2 during initial wave; T3 at three-months following the first wave). All members of the UK registered and unregistered nursing and midwifery workforce were eligible to participate. The survey was promoted via social media and through organisational email and newsletters. The primary outcome was an Impact of Events Scale-Revised score indicative of a post-traumatic stress disorder diagnosis (defined using the cut-off score ≥33). Multivariable logistic regression modelling was used to assess the association between explanatory variables and post-traumatic stress disorder. Results: We received 7840 eligible responses (T1- 2040; T2- 3638; T3- 2162). Overall, 91.6% participants were female, 77.2% were adult registered nurses, and 28.7% were redeployed during the pandemic. An Impact of Events Scale-Revised score ≥33 (probable post-traumatic stress disorder) was observed in 44.6%, 37.1%, and 29.3% participants at T1, T2, and T3 respectively. At all three time-points, both personal and workplace factors were associated with probable post-traumatic stress disorder, although some specific associations changed over the course of the pandemic. Increased age was associated with reduced probable post-traumatic stress disorder at T1 and T2 (e.g. 41-50 years at T1 odds ratio (OR) 0.60, 95% confidence interval (CI) 0.42-0.86), but not at T3. Similarly, redeployment with inadequate/ no training was associated with increased probable post-traumatic stress disorder at T1 and T2, but not at T3 (T1 OR 1.37, 95% CI 1.06-1.77; T3 OR 1.17, 95% CI 0.89-1.55). A lack of confidence in infection prevention and control training was associated with increased probable post-traumatic stress disorder at all three time-points (e.g. T1 OR 1.48, 95% CI 1.11-1.97). Conclusion: A negative psychological impact was evident 3-months following the first wave of the pandemic. Both personal and workplace are associated with adverse psychological effects linked to the COVID-19 pandemic. These findings will inform how healthcare organisations should respond to staff wellbeing needs both during the current pandemic, and in planning for future pandemics.
  • Prioritisation of early pregnancy risk factors for stillbirth: An international multistakeholder modified e-Delphi consensus study.

    Hough, Amy; Zamora, Javier; Thangaratinam, Shakila; Allotey, John (Elsevier, 2024-09-14)
    Objective: To identify and prioritise early pregnancy risk factors for stillbirth to inform prognostic factor and model research. Study design: We used a modified e-Delphi method and consultation meeting to achieve consensus. Risk factors for early, late and stillbirth at any gestation identified from an umbrella review of risk factors for stillbirth were entered into a two-stage online Delphi survey with an international group of stakeholders made up of healthcare professionals and researchers. The RAND/ University of California at Los Angeles appropriateness method was used to evaluate consensus. Responders voted on a scale of 1-9 for each risk factor in terms of importance for early, late, and stillbirth at any gestation. Consensus for inclusion was reached if the median score was in the top tertile and at least two thirds of panellists had scored the risk factor within the top tertile. Results: Twenty-six risk factors were identified from an umbrella review and presented to stakeholders in round 1 of our e-Delphi survey. Round 1 was completed by 68 stakeholders, 79% (54/68) of whom went on to complete the second round. Seventeen risk factors were discussed at the consensus meeting. From the twenty-six risk factors identified, fifteen of these were prioritised for stillbirth at any gestation, eleven for early stillbirth, and sixteen for late stillbirth, across three domains of maternal characteristics, ultrasound markers and biochemical markers. The prioritised maternal characteristics common to early, late, and stillbirth at any gestation were: maternal age, smoking, drug misuse, history of heritable thrombophilia, hypertension, renal disease, diabetes, previous stillbirth and multiple pregnancy. Maternal BMI, access to healthcare, and socioeconomic status were prioritised for late stillbirth and stillbirth at any gestation. Previous pre-eclampsia and previous small for gestational age baby were prioritised for late stillbirth. Of the ultrasound markers, uterine artery Doppler pulsatility index and congenital fetal anomaly were prioritised for all. One biochemical marker, placental growth factor, was prioritised for stillbirth at any gestation. Conclusions: Our prioritised risk factors for stillbirth can inform formal factor-outcome evaluation of early pregnancy risk factors to influence public health strategies on prevention of such risk factors to prevent stillbirth.
  • SARS-CoV-2 and the subsequent development of preeclampsia and preterm birth: evidence of a dose-response relationship supporting causality.

    Lai, Jonathan; Romero, Roberto; Tarca, Adi L; Iliodromiti, Stamatina; Rehal, Anoop; Banerjee, Anita; Yu, Christina; Peeva, Gergana; Palaniappan, Vadivu; Tan, Linda; et al. (Elsevier, 2021-08-26)
    No abstract available
  • Diagnosis and management of selective fetal growth restriction in monochorionic twin pregnancies: A cross-sectional international survey.

    Prasad, Smriti; Khalil, Asma; Kirkham, Jamie J; Sharp, Andrew; Woolfall, Kerry; Mitchell, Tracy Karen; Yaghi, Odai; Ricketts, Tracey; Popa, Mariana; Alfirevic, Zarko; et al. (Wiley-Blackwell, 2024-07-02)
    Objective: To identify current practices in the management of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies. Design: Cross-sectional survey. Setting: International. Population: Clinicians involved in the management of MCDA twin pregnancies with sFGR. Methods: A structured, self-administered survey. Main outcome measures: Clinical practices and attitudes to diagnostic criteria and management strategies. Results: Overall, 62.8% (113/180) of clinicians completed the survey; of which, 66.4% (75/113) of the respondents reported that they would use an estimated fetal weight (EFW) of <10th centile for the smaller twin and an inter-twin EFW discordance of >25% for the diagnosis of sFGR. For early-onset type I sFGR, 79.8% (75/94) of respondents expressed that expectant management would be their routine practice. On the other hand, for early-onset type II and type III sFGR, 19.3% (17/88) and 35.7% (30/84) of respondents would manage these pregnancies expectantly, whereas 71.6% (63/88) and 57.1% (48/84) would refer these pregnancies to a fetal intervention centre or would offer fetal intervention for type II and type III cases, respectively. Moreover, 39.0% (16/41) of the respondents would consider fetoscopic laser surgery (FLS) for early-onset type I sFGR, whereas 41.5% (17/41) would offer either FLS or selective feticide, and 12.2% (5/41) would exclusively offer selective feticide. For early-onset type II and type III sFGR cases, 25.9% (21/81) and 31.4% (22/70) would exclusively offer FLS, respectively, whereas 33.3% (27/81) and 32.9% (23/70) would exclusively offer selective feticide. Conclusions: There is significant variation in clinician practices and attitudes towards the management of early-onset sFGR in MCDA twin pregnancies, especially for type II and type III cases, highlighting the need for high-level evidence to guide management.
  • FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy - protocol for a prospective multicentre mixed-methods feasibility study

    Khalil, Asma; Prasad, Smriti; Woolfall, Kerry; Mitchell, Tracy Karen; Kirkham, Jamie J; Yaghi, Odai; Ricketts, Tracey; Attilakos, George; Bailie, Carolyn; Cornforth, Christine; et al. (BMJ Publishing Group, 2024-08-17)
    Introduction: Selective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and neurodisability for both twins. The condition poses unique management difficulties: on the one hand, continuation of the pregnancy carries a risk of death of the smaller twin, with a high risk of co-twin demise (40%) or co-twin neurological sequelae (30%). On the other, early delivery to prevent the death of the smaller twin may expose the larger twin to prematurity, with the associated risks of long-term physical, emotional and financial costs from neurodisability, such as cerebral palsy.When there is severe and early sFGR, before viability, delivery is not an option. In this scenario, there are currently three main management options: (1) expectant management, (2) selective termination of the smaller twin and (3) placental laser photocoagulation of interconnecting vessels. These management options have never been investigated in a randomised controlled trial (RCT). The best management option is unknown, and there are many challenges for a potential RCT. These include the rarity of the condition resulting in a small number of eligible pregnancies, uncertainty about whether pregnant women will agree to participate in such a trial and whether they will agree to be randomised to expectant management or active fetal intervention, and the challenges of robust and long-term outcome measures. Therefore, the main objective of the FERN study is to assess the feasibility of conducting an RCT of active intervention vs expectant management in monochorionic twin pregnancies with early-onset (prior to 24 weeks) sFGR. Methods and analysis: The FERN study is a prospective mixed-methods feasibility study. The primary objective is to recommend whether an RCT of intervention vs expectant management of sFGR in monochorionic twin pregnancy is feasible by exploring women's preference, clinician's preference, current practice and equipoise and numbers of cases. To achieve this, we propose three distinct work packages (WPs). WP1: A Prospective UK Multicentre Study, WP2A: a Qualitative Study Exploring Parents' and Clinicians' Views and WP3: a Consensus Development to Determine Feasibility of a Trial. Eligible pregnancies will be recruited to WP1 and WP2, which will run concurrently. The results of these two WPs will be used in WP3 to develop consensus on a future definitive study. The duration of the study will be 53 months, composed of 10 months of setup, 39 months of recruitment, 42 months of data collection, and 5 months of data analysis, report writing and recommendations. The pragmatic sample size for WP1 is 100 monochorionic twin pregnancies with sFGR. For WP2, interviews will be conducted until data saturation and sample variance are achieved, that is, when no new major themes are being discovered. Based on previous similar pilot studies, this is anticipated to be approximately 15-25 interviews in both the parent and clinician groups. Engagement of at least 50 UK clinicians is planned for WP3. Ethics and dissemination: This study has received ethical approval from the Health Research Authority (HRA) South West-Cornwall and Plymouth Ethics Committee (REC reference 20/SW/0156, IRAS ID 286337). All participating sites will undergo site-specific approvals for assessment of capacity and capability by the HRA. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. The results from the FERN project will be used to inform future studies. Trial registration number: This study is included in the ISRCTN Registry (ISRCTN16879394) and the NIHR Central Portfolio Management System (CPMS), CRN: Reproductive Health and Childbirth Specialty (UKCRN reference 47201).
  • Sexual and reproductive health clinical consultations: preconception care.

    Hough, Amy; Kavanagh, Jayne; Pathak, Neha; Hough, Amy; SHS; Medical and Dental (BMJ Publishing Group, 2024-08-08)
    No abstract available
  • Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: the MifeMiso RCT.

    Devall, Adam; Chu, Justin; Beeson, Leanne; Hardy, Pollyanna; Cheed, Versha; Sun, Yongzhong; Roberts, Tracy; Ogwulu, Chidubem Okeke; Williams, Eleanor; Jones, Laura; et al. (NIHR Journals Library, 2021-11)
    Trial design: A randomised, parallel-group, double-blind, placebo-controlled multicentre study with health economic and nested qualitative studies to determine if mifepristone (Mifegyne®, Exelgyn, Paris, France) plus misoprostol is superior to misoprostol alone for the resolution of missed miscarriage. Methods: Women diagnosed with missed miscarriage in the first 14 weeks of pregnancy were randomly assigned (1 : 1 ratio) to receive 200 mg of oral mifepristone or matched placebo, followed by 800 μg of misoprostol 2 days later. A web-based randomisation system allocated the women to the two groups, with minimisation for age, body mass index, parity, gestational age, amount of bleeding and randomising centre. The primary outcome was failure to pass the gestational sac within 7 days after randomisation. The prespecified key secondary outcome was requirement for surgery to resolve the miscarriage. A within-trial cost-effectiveness study and a nested qualitative study were also conducted. Women who completed the trial protocol were purposively approached to take part in an interview to explore their satisfaction with and the acceptability of medical management of missed miscarriage. Results: A total of 711 women, from 28 hospitals in the UK, were randomised to receive either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 out of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 out of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group (risk ratio 0.73, 95% confidence interval 0.54 to 0.98; p = 0.04). Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (risk ratio 0.70, 95% confidence interval 0.52 to 0.94; p = 0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A total of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview. Women appeared to have a preference for active management of their miscarriage. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The use of mifepristone and misoprostol showed an absolute effect difference of 6.6% (95% confidence interval 0.7% to 12.5%). The average cost per woman was lower in the mifepristone plus misoprostol group, with a cost saving of £182 (95% confidence interval £26 to £338). Therefore, the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. Limitations: The results from this trial are not generalisable to women diagnosed with incomplete miscarriage and the study does not allow for a comparison with expectant or surgical management of miscarriage. Future work: Future work should use existing data to assess and rank the relative clinical effectiveness and safety profiles for all methods of management of miscarriage. Conclusions: Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again. The mifepristone and misoprostol intervention was shown to be cost-effective in comparison to misoprostol alone. Trial registration: Current Controlled Trials ISRCTN17405024. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 68. See the NIHR Journals Library website for further project information. Plain language summary Miscarriage is a common complication of pregnancy, affecting approximately one in four women. Sometimes, medical treatment (i.e. tablets) may be offered to start or speed up the miscarriage process in order for the womb to empty itself. A drug called misoprostol (a tablet that makes the womb contract) is currently recommended for this treatment. However, the addition of another drug called mifepristone [a tablet that reduces pregnancy hormones (Mifegyne®, Exelgyn, Paris, France)] might help the miscarriage to resolve more quickly. Therefore, we carried out the MifeMiso trial to test if mifepristone plus misoprostol is more effective than misoprostol alone in resolving miscarriage within 7 days. Women were randomly allocated by a computer to receive either mifepristone or placebo, followed by misoprostol 2 days later. Neither the women nor their health-care professionals knew which treatment they received. Some women also talked to the researchers about their experiences of taking part in the study. In total, 711 women were randomised to receive either mifepristone plus misoprostol or placebo plus misoprostol. Overall, 83% of women who received mifepristone plus misoprostol had miscarriage resolution within 7 days, compared with 76% of the women who received a placebo plus misoprostol. Surgery was required less often in women who received mifepristone plus misoprostol: 17% of women who received it required surgery, compared with 25% of women who received the placebo. Treatment with mifepristone did not appear to have any negative effects. Treatment with mifepristone plus misoprostol was more cost-effective than misoprostol alone, with an average saving of £182 per woman. Having taken part in the study, most women would choose medical management again and would recommend it to someone they knew who was experiencing a miscarriage.
  • Cost-effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso trial.

    Okeke Ogwulu, C B; Williams, E V; Chu, J J; Devall, A J; Beeson, L E; Hardy, P; Cheed, V; Yongzhong, S; Jones, L L; La Fontaine Papadopoulos, J H; et al. (Wiley-Blackwell, 2021-06-07)
    Objective: To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. Design: Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS). Setting: Twenty-eight UK NHS early pregnancy units. Sample: A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage. Methods: Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets. Main outcome measures: Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs). Results: For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI -0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. Conclusions: The within-trial analysis found that based on cost-effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage. Tweetable abstract: The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.
  • Barriers and facilitators to healthcare practitioners providing care for pregnant women with epilepsy: A systematic review and narrative synthesis.

    Hughes, Anita; Weckesser, Annalise; Denny, Elaine; Junaid, Fatima; Nelson-Piercy, Cathy; Black, Mairead; Allotey, John; Thangaratinam, Shakila; Dyson, Judith (Elsevier, 2024-04-10)
    No abstract available
  • Quality framework for remote antenatal care: qualitative study with women, healthcare professionals and system-level stakeholders.

    Hinton, Lisa; Dakin, Francesca H; Kuberska, Karolina; Boydell, Nicola; Willars, Janet; Draycott, Tim; Winter, Cathy; McManus, Richard J; Chappell, Lucy C; Chakrabarti, Sanhita; et al. (BMJ Publishing Group, 2024-04-24)
    Background: High-quality antenatal care is important for ensuring optimal birth outcomes and reducing risks of maternal and fetal mortality and morbidity. The COVID-19 pandemic disrupted the usual provision of antenatal care, with much care shifting to remote forms of provision. We aimed to characterise what quality would look like for remote antenatal care from the perspectives of those who use, provide and organise it. Methods: This UK-wide study involved interviews and an online survey inviting free-text responses with: those who were or had been pregnant since March 2020; maternity professionals and managers of maternity services and system-level stakeholders. Recruitment used network-based approaches, professional and community networks and purposively selected hospitals. Analysis of interview transcripts was based on the constant comparative method. Free-text survey responses were analysed using a coding framework developed by researchers. Findings: Participants included 106 pregnant women and 105 healthcare professionals and managers/stakeholders. Analysis enabled generation of a framework of the domains of quality that appear to be most relevant to stakeholders in remote antenatal care: efficiency and timeliness; effectiveness; safety; accessibility; equity and inclusion; person-centredness and choice and continuity. Participants reported that remote care was not straightforwardly positive or negative across these domains. Care that was more transactional in nature was identified as more suitable for remote modalities, but remote care was also seen as having potential to undermine important aspects of trusting relationships and continuity, to amplify or create new forms of structural inequality and to create possible risks to safety. Conclusions: This study offers a provisional framework that can help in structuring thinking, policy and practice. By outlining the range of domains relevant to remote antenatal care, this framework is likely to be of value in guiding policy, practice and research.
  • Facilitating better postnatal care with women-held documents in The Gambia: a mixed-methods study.

    Gooden, Tiffany; Gustafsson, Lotta; Lu, Fides; Rickard, Faith; Sitch, Alice; Cummins, Carole; Manneh, Kebba; Wilson, Amie; MacArthur, Christine; Manaseki-Holland, Semira (BioMed Central, 2021-07-02)
    Background: Women-held documents are a basic component of continuity of maternity care. The use and completion of women-held documents following discharge could improve treatment and care for postnatal women. Using a mixed-methods study design, we aimed to assess the number, type, quality and completeness of women-held discharge documents, identify factors contributing to document completeness and facilitators or barriers for effective use of the documents. Methods: Documents given to women at discharge from three hospitals in the Greater Banjul Area, The Gambia, were reviewed for content and quality. All women completed a questionnaire on the use of the documents. Poisson regression was used to estimate factors predicting document completion. Semi-structured interviews (n = 21) and focus groups (n = 2) were carried out with healthcare professionals (HCPs). Results: Nearly all (n = 211/212; 99%) women were given a document to take home. The most complete document (maternal record) had on average 17/26 (65%) items completed and 10% of women held an illegible document. None of the women's sociodemographic or clinical characteristics predicted document completeness. The following facilitators for effective use of documents were identified from the women's responses to the questionnaire and interviews with HCPs: 94% of women thought written information is important, 99% plan to have postnatal check-ups and 67% plan to use their documents, HCPs understand the importance of the documents and were familiar with the document's use and content. The following barriers for effective use of documents were identified: HCPs had too many women-held documents to complete at discharge, there is no national protocol and HCPs think women do not understand the documents due to a lack of education and that women often lose or forget their documents. Conclusions: Women-held documents are well established in The Gambia; though quality and completeness needs improving. Future research should determine the impact of using only one document at discharge, protocols and training on completeness, among other outcomes, and on ways to ensure all women are using the documents for their postnatal care.
  • Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis.

    Fernández-García, Silvia; Del Campo-Albendea, Laura; Sambamoorthi, Dharshini; Sheikh, Jameela; Lau, Karen; Osei-Lah, Nana; Ramkumar, Anoushka; Naidu, Harshitha; Stoney, Nicole; Sundaram, Paul; et al. (BMJ Publishing Group, 2024-04-04)
    Sixty-seven studies (1 813 947 women) were included. Overall, in test-negative design studies, pregnant women fully vaccinated with any COVID-19 vaccine had 61% reduced odds of SARS-CoV-2 infection during pregnancy (OR 0.39, 95% CI 0.21 to 0.75; 4 studies, 23 927 women; I2=87.2%) and 94% reduced odds of hospital admission (OR 0.06, 95% CI 0.01 to 0.71; 2 studies, 868 women; I2=92%). In adjusted cohort studies, the risk of hypertensive disorders in pregnancy was reduced by 12% (RR 0.88, 95% CI 0.82 to 0.92; 2 studies; 115 085 women), while caesarean section was reduced by 9% (OR 0.91, 95% CI 0.85 to 0.98; 6 studies; 30 192 women). We observed an 8% reduction in the risk of neonatal intensive care unit admission (RR 0.92, 95% CI 0.87 to 0.97; 2 studies; 54 569 women) in babies born to vaccinated versus not vaccinated women. In general, vaccination during pregnancy was not associated with increased risk of adverse pregnancy or perinatal outcomes. Pain at the injection site was the most common side effect reported (77%, 95% CI 52% to 94%; 11 studies; 27 195 women).
  • Diagnostic criteria for retained products of conception-a scoping review

    Hamel, Charlotte C; van Wessel, Steffi; Carnegy, Alasdair; Coppus, Sjors F P J; Snijders, Marc P M L; Clark, Justin; Emanuel, Mark H (Wiley, 2021-08-12)
    Introduction: Numerous studies have been performed assessing optimal treatment regimens for evacuating (retained) products of conception from the uterus, but standardized criteria for diagnosing retained products of conception (RPOC) are still lacking. We aim to provide an overview of diagnostic criteria in current literature, used to diagnose RPOC after induced first-trimester abortion or early pregnancy loss. Material and methods: Pubmed, EMBASE, and the Cochrane library were searched systematically up until March 2020 for English articles reporting on induced abortion or early pregnancy loss. Articles not specifying diagnostic criteria used to assess completeness of treatment were excluded, as were conference abstracts, expert opinions, reviews, and case reports. Four elements of diagnostic criteria were described: diagnostic tools, parameters used within these tools, applied cut-off values, and timing of follow up. Additionally, a meta-analysis was performed assessing diagnostic qualities of the most often applied diagnostic tool and parameter. Results: The search strategy yielded 1233 unique articles, of which 248 were included, with a total of 339 517 participants. In the 79 included randomized controlled trials, six diagnostic tools to assess RPOC were identified, combined in 14 ways, with 55 different cut-off values. In 169 observational studies, seven diagnostic tools were identified, used in 28 combinations, applying 89 different cut-off values. Transvaginal ultrasonographic measurement of endometrial thickness with a cut-off value of at least 15 mm indicating RPOC, was used most frequently. In the timing of follow-up there was great variation, with 55 and 107 different combinations in randomized controlled trials and observational studies, respectively. Assessment of treatment success was scheduled most often around 2 weeks after treatment. Diagnostic qualities of endometrial thickness of 15 mm or more was not adequately assessed. Conclusions: There is wide variation in the way RPOC are assessed, and the criteria used to define RPOC following induced abortion and early pregnancy loss; ultrasonographic measurement of endometrial thickness, with a cut-off of 15 mm or more 2 weeks after primary treatment is the most widely used diagnostic approach. A meta-analysis on diagnostic accuracy of endometrial thickness of 15 mm or more did not lead to solid results. These findings can be a first step to develop a workable standard of establishing RPOC after induced abortion or early pregnancy loss.
  • Prevalence of and optimal screening tool for postpartum depression in a community-based population in China.

    Zeng, Zhen; Li, Qiao; Caine, Eric D; Takwoingi, Yemisi; Zhong, Baoliang; Tong, Yongsheng; Cheng, K K; Gong, Wenjie (Elsevier, 2023-12-27)
    Background: Postpartum depression (PPD) is an important public health problem worldwide. China is planning to launch PPD screening in community settings, but there are questions on the community prevalence of PPD and validated screening tools. Methods: We sought to recruit all eligible new mothers during postnatal home visits in two districts of Changsha, China, and after informed consent, screened them for PPD using three self-administered questionnaires-the Edinburgh Postpartum Depression Scale (EPDS), the Patient Health Questionnaire (PHQ-9), and Whooley Questions for Depression Screening. Video structured diagnostic interviews were performed online according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) by qualified specialists who were blinded to screening results. Optimal screening was determined based on the acceptability of scales and diagnostic accuracy metrics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Results: Out of 3004 eligible women, 2730 (90.9 %) completed the screening questionnaires. Among those screened, the video structured diagnostic interview was administered to 1862 (68.2 %) and 62 (3.3 %) were diagnosed with a current depressive condition. The optimal screening approach involved combining Whooley Questions (at least one "yes") with EPDS (cutoff >10) in series, with sensitivity of 0.76 (95 % CI 0.63 to 0.85), specificity of 0.93 (0.92 to 0.94), PPV of 0.28 (0.21 to 0.36) and NPV of 0.99 (0.98 to 1.00). Limitations: Due to the regional sample and exclusion of mothers with telephone contact rather than home visits, our findings may not be fully generalizable to the entire population. Conclusions: The prevalence of PPD among women in this sample was substantially lower than those reported in previous studies in China, the majority of which used screen positivity in measuring prevalence. Combining Whooley Questions with EPDS in series is the most optimal screening approach in this population, though this would still result in a high number of false positives at current prevalence.
  • Tailoring the response to COVID-19: experiences of an inner city maternity unit with a virtual patient surveillance approach.

    Elsmore, Amy; Redjepova, Oguljemal; Wright, Joselle; Malarselvi, Mani; Karkhanis, Pallavi; Malarselvi, Mani; Karkhanis, Pallavi; Obstetrics and Gynaecology; Medical and Dental (Informa Healthcare, 2022-02-18)
    This study outlines the characteristics and outcomes of pregnant women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We present the success of our 'COVID Surveillance Team' - a dedicated team of midwives and medics that regularly contact patients, identifying early any need for escalation of care. Data were collected prospectively from March to September 2020. Patients are followed up by our team for 14 days following diagnosis, via telephone. Maternal and neonatal outcomes were studied. Fifty-five women were diagnosed with COVID-19. 39/55 (70.9%) were of BAME background. 10/55 (18%) had medical comorbidities. 35/55 (63.6%) were diagnosed in the 3rd trimester, 7/55 (12.7%) were postnatal. Three women (5.4%) required critical care unit admission. One was transferred to a tertiary centre for extra-corporeal membrane oxygenation (ECMO), one patient died. Of the 43 deliveries, 28 (65.1%) underwent caesarean section. 11/45 (24.4%) of babies were born preterm. Eight babies were tested for COVID-19, one was positive. Our study demonstrates most pregnant women suffer mild illness, with no adverse outcomes for mother or neonate. We highlight the success of our COVID surveillance team, that should be considered best practice and consideration should be given for adoption by other maternity units to enhance patient safety.Impact StatementWhat is already known on this subject? Many studies present maternal and neonatal characteristics and outcomes of COVID-19 infection in the pregnant population, demonstrating most patients suffer mild disease with minimal adverse outcomes.What do the results of this study add? We highlight the important work of our COVID surveillance team, and the positive impact it has had on the wellbeing and safety of our women. We believe we are the first maternity unit in the UK to adopt and report on a virtual patient surveillance approach supporting our patients and leading to increased patient safety.What are the implications of these findings for clinical practice and/or further research? Our surveillance team has proved very successful and has been described as exemplar by NHS England and promoted as best practice. This approach could be adopted by other units, within the UK and further afield, for the benefit of women's health and safety. The team has shared their guidance and standard operating procedure with maternity units across the UK.
  • Factors affecting the implementation of calcium supplementation strategies during pregnancy to prevent pre-eclampsia: a mixed-methods systematic review

    Cormick, Gabriela; Moraa, Hellen; Zahroh, Rana Islamiah; Allotey, John; Rocha, Thaís; Peña-Rosas, Juan Pablo; Qureshi, Zahida P; Hofmeyr, G Justus; Mistry, Hema; Smits, Luc; et al. (BMJ Publishing Group, 2023-12-22)
    Objectives: Daily calcium supplements are recommended for pregnant women from 20 weeks' gestation to prevent pre-eclampsia in populations with low dietary calcium intake. We aimed to improve understanding of barriers and facilitators for calcium supplement intake during pregnancy to prevent pre-eclampsia. Design: Mixed-method systematic review, with confidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative research approach. Data sources: MEDLINE and EMBASE (via Ovid), CINAHL and Global Health (via EBSCO) and grey literature databases were searched up to 17 September 2022. Eligibility criteria: We included primary qualitative, quantitative and mixed-methods studies reporting implementation or use of calcium supplements during pregnancy, excluding calcium fortification and non-primary studies. No restrictions were imposed on settings, language or publication date. Data extraction and synthesis: Two independent reviewers extracted data and assessed risk of bias. We analysed the qualitative data using thematic synthesis, and quantitative findings were thematically mapped to qualitative findings. We then mapped the results to behavioural change frameworks to identify barriers and facilitators. Results: Eighteen reports from nine studies were included in this review. Women reported barriers to consuming calcium supplements included limited knowledge about calcium supplements and pre-eclampsia, fears and experiences of side effects, varying preferences for tablets, dosing, working schedules, being away from home and taking other supplements. Receiving information regarding pre-eclampsia and safety of calcium supplement use from reliable sources, alternative dosing options, supplement reminders, early antenatal care, free supplements and support from families and communities were reported as facilitators. Healthcare providers felt that consistent messaging about benefits and risks of calcium, training, and ensuring adequate staffing and calcium supply is available would be able to help them in promoting calcium. Conclusion: Relevant stakeholders should consider the identified barriers and facilitators when formulating interventions and policies on calcium supplement use. These review findings can inform implementation to ensure effective and equitable provision and scale-up of calcium interventions.
  • Covariate analysis query: Hospital surgical volume-outcome relationship in caesarean hysterectomy for placenta accreta spectrum.

    Redjepova, Oguljemal; Lowe-Zinola, Jack; Griffin, Christopher; Redjepova, Oguljemal; Lowe-Zinola, Jack; Obstetrics & Gynaecology; Doctors; Medical and Dental; Sandwell and West Birmingham NHS Trust; University Hospitals Birmingham NHS Trust; Notre Dame Medical School (Wiley, 2022-01-07)
    No abstract available

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