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Background: Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis, and extraction can be difficult. Numerous techniques are reported, but the superiority of one over another is contentious and there is no national guidance. Objective To determine the feasibility of a randomised trial of different techniques for managing an impacted fetal head during emergency caesarean. Design A scoping study with five work packages: (1) national surveys to determine current practice and acceptability of research in this area, and a qualitative study to determine acceptability to women who have experienced a second-stage caesarean; (2) a national prospective observational study to determine incidence and rate of complications; (3) a Delphi survey and consensus meeting on choice of techniques and outcomes for a trial; (4) the design of a trial; and (5) a national survey and qualitative study to determine acceptability of the proposed trial. Setting Secondary care. Participants Health-care professionals, pregnant women, women who have had a second-stage caesarean, and parents. Results Most (244/279, 87%) health-care professionals believe that a trial in this area would help guide their practice, and 90% (252/279) would be willing to participate in such a trial. Thirty-eight per cent (98/259) of parents reported that they would take part. Women varied in which technique they thought was most acceptable. Our observational study found that impacted head is common (occurring in 16% of second-stage caesareans) and leads to both maternal (41%) and neonatal (3.5%) complications. It is most often treated by an assistant pushing the head up vaginally. We designed a randomised clinical trial comparing the fetal pillow with the vaginal push technique. The vast majority of health-care professionals, 83% of midwives and 88% of obstetricians, would be willing to participate in the trial proposed, and 37% of parents reported that they would take part. Our qualitative study found that most participants thought the trial would be feasible and acceptable. Limitations Our survey is subject to the limitation that, although responses refer to contemporaneous real cases, they are self-reported by the surgeon and collected after the event. Willingness to participate in a hypothetical trial may not translate into recruitment to a real trial. Conclusions We proposed a trial to compare a new device, the fetal pillow, with a long-established procedure, the vaginal push technique. Such a trial would be widely supported by health-care professionals. We recommend that it be powered to test an effect on important short term maternal and baby outcomes which would require 754 participants per group. Despite the well-known difference between intent and action, this would be feasible within the UK. Future work We recommend a randomised controlled trial of two techniques for managing an impacted fetal head with an in-built internal pilot phase and alongside economic and qualitative substudies. Study registration This study is registered as Research Registry 4942. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 6. See the NIHR Journals Library website for further project information. Plain language summary: One-quarter of UK pregnant women have a caesarean section. Most of these procedures are straightforward, but in a small number of cases unexpected complications can make the birth difficult. One complication, an impacted fetal head, may happen when caesarean sections are done in the second ‘pushing’ stage of labour. If the baby’s head is low and wedged in the woman’s pelvis, lifting it can be difficult, which can result in damage to the mother’s womb and vagina, and to her baby. Occasionally, babies die. There are different techniques doctors and midwives can use to make these births easier, but there is uncertainty around which is best. To plan a trial to test these techniques, we needed to know how often impacted head happens, what techniques are used to manage it and whether or not research is acceptable to parents and health-care professionals. We surveyed doctors and midwives to find out which techniques they use and what training they need. We surveyed parents and pregnant women and interviewed women who had experienced a second-stage caesarean. We collected information from UK hospitals to find out how common this is and the impact on women and babies. We found out the following: Around 7% of caesareans take place in second stage, and impacted fetal head occurs in 16% of these births. One-third of women would consent to take part in a trial, if the complication happened to them. Nearly all midwives and doctors thought that this research was important and would be willing to take part. Using all of the information we collected, we designed a clinical trial. We wanted to compare two techniques for managing an impacted fetal head. The first is the vaginal push technique, where the doctor or midwife puts their hand into the mother’s vagina to push her baby’s head up, and the second is the fetal pillow, a device inserted into the mother’s vagina before the operation starts to dislodge the baby’s head upwards. Scientific summary: Background Emergency caesarean section (CS) performed in the second stage of labour, which occurs in 34,000 births per annum in the UK, has greater perinatal and maternal morbidity than CS performed in the first stage. Second-stage CS may be complicated by the fetal head being deeply impacted in the maternal pelvis, which occurs in 1.5% of all emergency CSs. Complications include longer delivery times, uterine tears, injury to the baby and even, albeit rarely, death. Numerous techniques to assist in delivery of an impacted fetal head (IFH) are reported. The superiority of one technique over another is contentious. At present, there is no national guidance on what techniques to employ. Research questions What are the current practice, level of experience and training requirements for managing an IFH during emergency CS among UK obstetricians, obstetric anaesthetists and midwives? What are the views of pregnant women and their partners on research in this area? How acceptable is a randomised trial in this area to women who have experienced a second-stage caesarean birth, and what are their views on the different proposed techniques for managing an IFH? What is the incidence of IFH and maternal and neonatal complications arising from IFH in the UK? What techniques and outcomes do health-care professionals and parents think should be included in a randomised trial in IFH? What should the design be for a randomised trial in IFH? How acceptable is the randomised trial we have designed to health-care professionals, women who have experienced a second-stage caesarean birth and pregnant women? Methods We undertook a national survey of obstetricians, trainee obstetricians, obstetric anaesthetists and midwives to determine current practice, level of experience and training requirements for managing IFH during emergency CS. We also undertook a national survey of parents to determine their views on this topic. Individual face-to-face interviews with women who have experienced a second-stage CS were carried out to determine the acceptability of a randomised trial in this area and their views on the different proposed techniques for managing IFH. A national, prospective UK Obstetric Surveillance System (UKOSS) surveillance study was undertaken to determine the incidence and consequences of IFH in the UK. Based on the findings of previous work packages, we conducted a Delphi survey followed by a virtual consensus meeting of experts and important stakeholders to decide which techniques should be tested in any trial and which outcomes should be included. A randomised trial of different techniques for managing IFH during emergency CS was designed. We undertook a national survey of lead obstetricians, pregnant women and midwives to determine the feasibility and acceptability of the randomised trial designed. Three sets of individual telephone or video interviews were carried out with lead obstetricians/senior obstetric trainees, women who have experienced a second-stage CS and primiparous women to determine the acceptability and feasibility of the planned trial. Results The majority (89%) of health-care professionals stated that a clinical trial in this area would help to guide their clinical practice, and 87% would be willing to participate in such a trial. In addition, 37% of parents reported that they would be either likely or very likely to take part, or neutral. Women varied in which technique they thought was most acceptable, and their trust in medical expertise and prioritising the safety of the baby were important moderators of acceptability. Our national prospective observational study found that impacted head is common, occurring in 16% of second-stage caesarean births in the UK, and leads to both maternal and neonatal complications. Overall, 230 (41%) women and 20 babies (3.5%) experienced complications. Thirteen babies (2%) died or sustained severe injury. Seven suffered bony fracture, two brachial plexus injury and one facial palsy. Three had moderate or severe hypoxic ischaemic encephalopathy, and seven were cooled. Four babies died: one prior to the caesarean, one with multiple abnormalities and two as a direct result of complications caused by IFH. IFH is currently most often treated by an assistant pushing the head up vaginally during the CS. Data from earlier work packages were used throughout the project, culminating in the design of a randomised clinical trial. Our proposed trial would compare a new device, the fetal pillow, with a procedure used for many years, the vaginal push technique, for preventing IFH. Most doctors and midwives believed that such a trial would be important and were willing to recruit participants to one. About one in three women said that they would be willing to join such a trial. The only interventions that were more popular with patients were tocolysis and the head-down technique. Both of these are adjunct techniques used by all obstetricians and, therefore, are not suitable for evaluation in a trial. The required sample size of such a trial depends on whether it is powered to show a difference in severe maternal morbidity (control event rate 2.3%, 4698 participants per group), a difference in fetal short-term morbidity (control event rate 13.7%, 754 participants per group) or only a difference in less severe maternal events, including haemorrhage over 1000 ml (control event rate 27%, 322 participants per group). We believe that it is not feasible to conduct the trial powered on severe maternal morbidity. However, parents and doctors believe that a trial to test the effect of different procedures on meaningful baby outcomes is important. We therefore recommend that the required sample size would be 754 per group. The vast majority of midwives (83%) and obstetricians (88%) would be willing to participate in the clinical trial proposed. In addition, 37% of parents reported that they would be either likely or very likely to take part, or neutral. Our qualitative study found that most participants thought that the trial would be feasible and acceptable. Conclusions We recommend that a randomised trial with an internal pilot phase comparing a new device, the fetal pillow, with a procedure used for many years, the vaginal push technique, for managing IFH be conducted. This trial is widely supported by health-care professionals. We recommend that the definitive trial be powered to test an effect on important short-term maternal and baby outcomes, which would require 754 participants per group. A sufficient number of women would be willing to be join such a trial to make it likely to be feasible in the UK. Study registration This study is registered as Research Registry 4942. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 6. See the NIHR Journals Library website for further project information.

Objective: Warm water immersion during labour provides women with analgesia and comfort. This cohort study aimed to establish among women using intrapartum water immersion analgesia, without antenatal or intrapartum risk factors, whether waterbirth is as safe for them and their babies as leaving the water before birth., Design: Cohort study with non-inferiority design., Setting: Twenty-six UK NHS maternity services., Sample: A total of 73 229 women without antenatal or intrapartum risk factors, using intrapartum water immersion, between 1 January 2015 and 30 June 2022. The analysis excluded 12 827 (17.5%) women who received obstetric or anaesthetic interventions before birth., Methods: Non-inferiority analysis of retrospective and prospective data captured in NHS maternity and neonatal information systems., Main Outcome Measures: Maternal primary outcome: obstetric anal sphincter injury (OASI) by parity; neonatal composite primary outcome: fetal or neonatal death, neonatal unit admission with respiratory support or administration of antibiotics within 48 hours of birth., Results: Rates of the primary outcomes were no higher among waterbirths compared with births out of water: rates of OASI among nulliparous women (waterbirth: 730/15 176 [4.8%] versus births out of water: 641/12 210 [5.3%]; adjusted odds ratio [aOR] 0.97, one-sided 95% CI, -∞ to 1.08); rates of OASI among parous women (waterbirth: 269/24 451 [1.1%] versus births out of water 144/8565 [1.7%]; aOR 0.64, one-sided 95% CI -∞ to 0.78) and rates of the composite adverse outcome among babies (waterbirth 263/9868 [2.7%] versus births out of water 224/5078 [4.4%]; aOR 0.65, one-sided 95% CI -∞ to 0.79)., Conclusion: Among women using water immersion during labour, remaining in the pool and giving birth in water was not associated with an increase in the incidence of adverse primary maternal or neonatal outcomes., (© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Objectives: Antenatal education (ANE) is part of National Health Service (NHS) care and is recommended by The National Institute for Health and Care Excellence (NICE) to increase birth preparedness and help pregnant women/birthing people develop coping strategies for labour and birth. We aimed to understand antenatal educator views about how current ANE supports preparedness for childbirth, including coping strategy development with the aim of identifying targets for improvement., Methods: A United Kingdom wide, cross-sectional online survey was conducted between October 2019 and May 2020. Antenatal educators including NHS midwives and private providers were purposively sampled. Counts and percentages were calculated for closed responses and thematic analysis used for open text responses., Results: Ninety-nine participants responded, 62% of these did not believe that ANE prepared women for labour and birth. They identified practical barriers to accessing ANE, particularly for marginalised groups, including financial and language barriers. Educators believe class content is medically focused, and teaching is of variable quality with some midwives being ill-prepared to deliver antenatal education. 55% of antenatal educators believe the opportunity to develop coping strategies varies between location and educators and only those women who can pay for non-NHS classes are able to access all the coping strategies that can support them with labour and birth., Conclusions for Practice: Antenatal educators believe current NHS ANE does not adequately prepare women for labour and birth, leading to disparities in birth preparedness for those who cannot access non-NHS classes. To reduce this healthcare inequality, NHS classes need to be standardised, with training for midwives in delivering ANE enhanced., (© 2024. The Author(s).)

Objective: Our objective was to codesign, implement, evaluate acceptability and refine an optimised antenatal education session to improve birth preparedness., Design: There were four distinct phases: codesign (focus groups and codesign workshops with parents and staff); implementation of intervention; evaluation (interviews, questionnaires, structured feedback forms) and systematic refinement., Setting: The study was set in a single maternity unit with approximately 5500 births annually., Participants: Postnatal and antenatal women/birthing people and birth partners were invited to participate in the intervention, and midwives were invited to deliver it. Both groups participated in feedback., Outcome Measures: We report on whether the optimised session is deliverable, acceptable, meets the needs of women/birthing people and partners, and explain how the intervention was refined with input from parents, clinicians and researchers., Results: The codesign was undertaken by 35 women, partners and clinicians. Five midwives were trained and delivered 19 antenatal education (ACE) sessions to 142 women and 94 partners. 121 women and 33 birth partners completed the feedback questionnaire. Women/birthing people (79%) and birth partners (82%) felt more prepared after the class with most participants finding the content very helpful or helpful. Women/birthing people perceived classes were more useful and engaging than their partners. Interviews with 21 parents, a midwife focus group and a structured feedback form resulted in 38 recommended changes: 22 by parents, 5 by midwives and 11 by both. Suggested changes have been incorporated in the training resources to achieve an optimised intervention., Conclusions: Engaging stakeholders (women and staff) in codesigning an evidence-informed curriculum resulted in an antenatal class designed to improve preparedness for birth, including assisted birth, that is acceptable to women and their birthing partners, and has been refined to address feedback and is deliverable within National Health Service resource constraints. A nationally mandated antenatal education curriculum is needed to ensure parents receive high-quality antenatal education that targets birth preparedness., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Over a fifth of pregnant women are living with multiple long-term health conditions, which is associated with increased risks of adverse outcomes for mothers and infants. While there are many examples of research exploring individuals' experiences and care pathways for pregnancy with a single health condition, evidence relating to multiple health conditions is limited. This study aimed to explore experiences and care of women with multiple long-term health conditions around the time of pregnancy., Methods: Semistructured interviews were conducted between March 2022 and May 2023 with women with multiple long-term health conditions who were at least 28 weeks pregnant or had had a baby in the last 2 years, and healthcare professionals with experience of caring for these women. Participants were recruited from across the United Kingdom. Data were analysed using thematic analysis., Results: Fifty-seven women and 51 healthcare professionals participated. Five themes were identified. Women with long-term health conditions and professionals recognised that it takes a team to avoid inconsistent care and communication, for example, medication management. Often, women were required to take a care navigation role to link up their healthcare providers. Women described mixed experiences regarding care for their multiple identities and the whole person. Postnatally, women and professionals recognised a downgrade in care, particularly for women's long-term health conditions. Some professionals detailed the importance of engaging with women's knowledge, and recognising their own professional boundaries of expertise. Many participants described difficulties in providing informational continuity and subsequent impacts on care. Specifically, the setup of care systems made it difficult for everyone to access necessary information, especially when care involved multiple sites., Conclusion: Pregnant women with long-term health conditions can experience a substantial burden of responsibility to maintain communication with their care team, often feeling vulnerable, patronised, and let down by a lack of acknowledgement of their expertise. These results will be used to inform the content of coproduction workshops aimed at developing a list of care recommendations for affected women. It will also inform future interventional studies aimed at improving outcomes for these women and their babies., Patient or Public Contribution: Our Patient and Public Involvement group were involved in the design of the study and the analysis and interpretation of the data, and a public study investigator was part of the author group., (© 2024 The Author(s). Health Expectations published by John Wiley & Sons Ltd.)

Objectives: To estimate the incidence of, and investigate risk factors for, postpartum haemorrhage (PPH) requiring transfer to obstetric care following birth in midwifery units (MU) in the UK; to describe outcomes for women who experience PPH requiring transfer to obstetric care., Methods: We conducted a national population-based case-control study in all MUs in the UK using the UK Midwifery Study System (UKMidSS). Between September 2019 and February 2020, 1501 women with PPH requiring transfer to obstetric care following birth in an MU, and 1475 control women were identified. We used multivariable logistic regression, generating adjusted odds ratios (aORs) and 95% confidence intervals (CIs) to investigate risk factors for PPH requiring transfer to obstetric care., Results: The incidence of PPH requiring transfer to obstetric care following birth in an MU was 3.7% (95% CI 3.6%-3.9%). Factors independently associated with PPH requiring transfer to obstetric care were smoking during pregnancy (aOR = 0.73; 95% CI 0.56-0.94), nulliparity (aOR = 1.96; 95% CI 1.66-2.30), previous PPH (aOR = 2.67; 95% CI 1.67-4.25), complications in a previous pregnancy other than PPH (aOR = 2.40; 95% CI 1.25-4.60), gestational age ≥41 weeks (aOR = 1.36; 95% CI 1.10-1.69), instrumental birth (aOR = 2.69; 95% CI 1.53-4.72), third stage of labour ≥60 minutes (aOR = 5.56; 95% CI 3.93-7.88), perineal trauma (aOR = 4.67; 95% CI 3.16-6.90), and birthweight 3500-3999g (aOR = 1.71; 95% CI 1.42-2.07) or ≥4000g (aOR = 2.31; 95% CI 1.78-3.00). One in ten (10.6%) cases received a blood transfusion and one in five (21.0%) were admitted to higher level care., Conclusions: The risk factors identified in this study align with those identified in previous research and with current guidelines for women planning birth in an MU in the UK. Maternal outcomes after PPH were broadly reassuring and indicative of appropriate management. NHS organisations should ensure that robust guidelines are in place to support management of PPH in MUs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Elkington et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Multimorbidity is common in women across the life course. Preterm birth is the single biggest cause of neonatal mortality and morbidity. We aim to estimate the prevalence of multimorbidity in pregnant women and to examine the association between maternal multimorbidity and PTB., Methods: This is a retrospective cohort study using electronic health records from the Scottish Morbidity Records. All pregnancies among women aged 15 to 49 with a conception date between 1 January 2014 and 31 December 2018 were included. Multimorbidity was defined as the presence of two or more pre-existing long-term physical or mental health conditions, and complex multimorbidity as the presence of four or more. It was calculated at the time of conception using a predefined list of 79 conditions published by the MuM-PreDiCT consortium. PTB was defined as babies born alive between 24 and less than 37 completed weeks of gestation. We used Generalised Estimating Equations adjusted for maternal age, socioeconomic status, number of previous pregnancies, BMI, and smoking history to estimate the effect of maternal pre-existing multimorbidity. Absolut rates are reported in the results and tables, whilst Odds Ratios (ORs) are adjusted (aOR)., Results: Thirty thousand five hundred fifty-seven singleton births from 27,711 pregnant women were included in the analysis. The prevalence of pre-existing multimorbidity and complex multimorbidity was 16.8% (95% CI: 16.4-17.2) and 3.6% (95% CI: 3.3-3.8), respectively. The prevalence of multimorbidity in the youngest age group was 10.2%(95% CI: 8.8-11.6), while in those 40 to 44, it was 21.4% (95% CI: 18.4-24.4), and in the 45 to 49 age group, it was 20% (95% CI: 8.9-31.1). In women without multimorbidity, the prevalence of PTB was 6.7%; it was 11.6% in women with multimorbidity and 15.6% in women with complex multimorbidity. After adjusting for maternal age, socioeconomic status, number of previous pregnancies, Body Mass Index (BMI), and smoking, multimorbidity was associated with higher odds of PTB (aOR = 1.64, 95% CI: 1.48-1.82)., Conclusions: Multimorbidity at the time of conception was present in one in six women and was associated with an increased risk of preterm birth. Multimorbidity presents a significant health burden to women and their offspring. Routine and comprehensive evaluation of women with multimorbidity before and during pregnancy is urgently needed., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Heterogeneity in reported outcomes can limit the synthesis of research evidence. A core outcome set informs what outcomes are important and should be measured as a minimum in all future studies. We report the development of a core outcome set applicable to observational and interventional studies of pregnant women with multimorbidity., Methods: We developed the core outcome set in four stages: (i) a systematic literature search, (ii) three focus groups with UK stakeholders, (iii) two rounds of Delphi surveys with international stakeholders and (iv) two international virtual consensus meetings. Stakeholders included women with multimorbidity and experience of pregnancy in the last 5 years, or are planning a pregnancy, their partners, health or social care professionals and researchers. Study adverts were shared through stakeholder charities and organisations., Results: Twenty-six studies were included in the systematic literature search (2017 to 2021) reporting 185 outcomes. Thematic analysis of the focus groups added a further 28 outcomes. Two hundred and nine stakeholders completed the first Delphi survey. One hundred and sixteen stakeholders completed the second Delphi survey where 45 outcomes reached Consensus In (≥70% of all participants rating an outcome as Critically Important). Thirteen stakeholders reviewed 15 Borderline outcomes in the first consensus meeting and included seven additional outcomes. Seventeen stakeholders reviewed these 52 outcomes in a second consensus meeting, the threshold was ≥80% of all participants voting for inclusion. The final core outcome set included 11 outcomes. The five maternal outcomes were as follows: maternal death, severe maternal morbidity, change in existing long-term conditions (physical and mental), quality and experience of care and development of new mental health conditions. The six child outcomes were as follows: survival of baby, gestational age at birth, neurodevelopmental conditions/impairment, quality of life, birth weight and separation of baby from mother for health care needs., Conclusions: Multimorbidity in pregnancy is a new and complex clinical research area. Following a rigorous process, this complexity was meaningfully reduced to a core outcome set that balances the views of a diverse stakeholder group., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Using routinely collected clinical data for observational research is an increasingly important method for data collection, especially when rare outcomes are being explored. The POOL study was commissioned to evaluate the safety of waterbirth in the UK using routine maternity and neonatal clinical data. This paper describes the design, rationale, set-up and pilot for this data linkage study using bespoke methods., Methods: Clinical maternity information systems hold many data items of value for research purposes, but often lack specific data items required for individual studies. This study used the novel method of amending an existing clinical maternity database for the purpose of collecting additional research data fields. In combination with the extraction of existing data fields, this maximised the potential use of existing routinely collected clinical data for research purposes, whilst reducing NHS staff data collection burden.Wellbeing Software ® , provider of the Euroking ® Maternity Information System, added new study specific data fields to their information system, extracted data from participating NHS sites and transferred data for matching with the National Neonatal Research Database to ascertain outcomes for babies admitted to neonatal units. Study set-up processes were put in place for all sites. The data extraction, linkage and cleaning processes were piloted with one pre-selected NHS site., Results: Twenty-six NHS sites were set-up over 27 months (January 2019 - April 2021). Twenty-four thousand maternity records were extracted from the one NHS site, pertaining to the period January 2015 to March 2019. Data field completeness for maternal and neonatal primary outcomes were mostly acceptable. Neonatal identifiers flowed to the National Neonatal Research Database for successful matching and linkage between maternity and neonatal unit records., Discussion: Piloting the data extraction and linkage highlighted the need for additional governance arrangements, training at NHS sites and new processes for the study team to ensure data quality and confidentiality are upheld during the study. Amending existing NHS electronic information systems and accessing clinical data at scale, is possible, but continues to be a time consuming and a technically challenging exercise., Competing Interests: Statement of conflict of interests: The authors declare that they have no competing interests.

Background: Maternal multiple long-term conditions are associated with adverse outcomes for mother and child. We conducted a qualitative study to inform a core outcome set for studies of pregnant women with multiple long-term conditions., Methods: Women with two or more pre-existing long-term physical or mental health conditions, who had been pregnant in the last five years or planning a pregnancy, their partners and health care professionals were eligible. Recruitment was through social media, patients and health care professionals' organisations and personal contacts. Participants who contacted the study team were purposively sampled for maximum variation. Three virtual focus groups were conducted from December 2021 to March 2022 in the United Kingdom: (i) health care professionals (n = 8), (ii) women with multiple long-term conditions (n = 6), and (iii) women with multiple long-term conditions (n = 6) and partners (n = 2). There was representation from women with 20 different physical health conditions and four mental health conditions; health care professionals from obstetrics, obstetric/maternal medicine, midwifery, neonatology, perinatal psychiatry, and general practice. Participants were asked what outcomes should be reported in all studies of pregnant women with multiple long-term conditions. Inductive thematic analysis was conducted. Outcomes identified in the focus groups were mapped to those identified in a systematic literature search in the core outcome set development., Results: The focus groups identified 63 outcomes, including maternal (n = 43), children's (n = 16) and health care utilisation (n = 4) outcomes. Twenty-eight outcomes were new when mapped to the systematic literature search. Outcomes considered important were generally similar across stakeholder groups. Women emphasised outcomes related to care processes, such as information sharing when transitioning between health care teams and stages of pregnancy (continuity of care). Both women and partners wanted to be involved in care decisions and to feel informed of the risks to the pregnancy and baby. Health care professionals additionally prioritised non-clinical outcomes, including quality of life and financial implications for the women; and longer-term outcomes, such as children's developmental outcomes., Conclusions: The findings will inform the design of a core outcome set. Participants' experiences provided useful insights of how maternity care for pregnant women with multiple long-term conditions can be improved., (© 2023. The Author(s).)

Objectives: To compare neonatal mortality in English hospitals by time of day and day of the week according to care pathway., Design: Retrospective cohort linking birth registration, birth notification and hospital episode data., Setting: National Health Service (NHS) hospitals in England., Participants: 6 054 536 liveborn singleton births from 2005 to 2014 in NHS maternity units in England., Main Outcome Measures: Neonatal mortality., Results: After adjustment for confounders, there was no significant difference in the odds of neonatal mortality attributed to asphyxia, anoxia or trauma outside of working hours compared with working hours for spontaneous births or instrumental births. Stratification of emergency caesareans by onset of labour showed no difference in mortality by birth timing for emergency caesareans with spontaneous or induced onset of labour. Higher odds of neonatal mortality attributed to asphyxia, anoxia or trauma out of hours for emergency caesareans without labour translated to a small absolute difference in mortality risk., Conclusions: The apparent 'weekend effect' may result from deaths among the relatively small numbers of babies who were coded as born by emergency caesarean section without labour outside normal working hours. Further research should investigate the potential contribution of care-seeking and community-based factors as well as the adequacy of staffing for managing these relatively unusual emergencies., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: Caesarean sections (CS) account for 26% of all births in the UK, of which at least 5% are done at full dilatation, in the second stage of labour. Second stage CS may be complicated by the fetal head being deeply impacted in the maternal pelvis, requiring specialist skills to achieve a safe birth. Numerous techniques are used to manage impacted fetal head, however, there are no national clinical guidelines in the UK., Aim: To explore health professionals' and women's views on the acceptability and feasibility of a randomised controlled trial (RCT) designed to explore approaches to managing an impacted fetal head during emergency CS., Methods: Semi-structured interviews with 10 obstetricians and 16 women (6 pregnant and 10 who experienced an emergency second stage CS). Interviews were transcribed and analysed using systematic thematic analysis., Results: The findings considered the time at which you obtain consent, how and when information about the RCT is presented, and barriers and facilitators to recruiting health professionals and women into the RCT. Obstetricians emphasised the importance of training in the techniques, as well as the potential conflict between the RCT protocol and current site or individual practices. Women said they would trust health professionals' to use the most appropriate technique and abandon the RCT protocol if necessary. Similarly, obstetricians raised the tension between the RCT protocol versus safety in reverting to what they knew under emergency situations. Both groups reflected on how this might affect the authenticity of the results. A range of important maternal, infant and clinical outcomes were raised by women and obstetricians. However, there were varying views on which of the two RCT designs presented to participants would be preferred. Most participants thought the RCT would be feasible and acceptable., Conclusions: This study suggests an RCT designed to evaluate different techniques for managing an impacted fetal head would be feasible and acceptable. However, it also identified a number of challenges that need to be considered when designing such an RCT. Results can be used to inform the design of RCTs in this area., (© 2023. The Author(s).)

Introduction: One in five pregnant women has multiple pre-existing long-term conditions in the UK. Studies have shown that maternal multiple long-term conditions are associated with adverse outcomes. This observational study aims to compare maternal and child outcomes for pregnant women with multiple long-term conditions to those without multiple long-term conditions (0 or 1 long-term conditions)., Methods and Analysis: Pregnant women aged 15-49 years old with a conception date between 2000 and 2019 in the UK will be included with follow-up till 2019. The data source will be routine health records from all four UK nations (Clinical Practice Research Datalink (England), Secure Anonymised Information Linkage (Wales), Scotland routine health records and Northern Ireland Maternity System) and the Born in Bradford birth cohort. The exposure of two or more pre-existing, long-term physical or mental health conditions will be defined from a list of health conditions predetermined by women and clinicians. The association of maternal multiple long-term conditions with (a) antenatal, (b) peripartum, (c) postnatal and long-term and (d) mental health outcomes, for both women and their children will be examined. Outcomes of interest will be guided by a core outcome set. Comparisons will be made between pregnant women with and without multiple long-term conditions using modified Poisson and Cox regression. Generalised estimating equation will account for the clustering effect of women who had more than one pregnancy episode. Where appropriate, multiple imputation with chained equation will be used for missing data. Federated analysis will be conducted for each dataset and results will be pooled using random-effects meta-analyses., Ethics and Dissemination: Approval has been obtained from the respective data sources in each UK nation. Study findings will be submitted for publications in peer-reviewed journals and presented at key conferences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: The number of medications prescribed during pregnancy has increased over the past few decades. Few studies have described the prevalence of multiple medication use among pregnant women. This study aims to describe the overall prevalence over the last two decades among all pregnant women and those with multimorbidity and to identify risk factors for polypharmacy in pregnancy., Methods: A retrospective cohort study was conducted between 2000 and 2019 using the Clinical Practice Research Datalink (CPRD) pregnancy register. Prescription records for 577 medication categories were obtained. Prevalence estimates for polypharmacy (ranging from 2+ to 11+ medications) were presented along with the medications commonly prescribed individually and in pairs during the first trimester and the entire pregnancy period. Logistic regression models were performed to identify risk factors for polypharmacy., Results: During the first trimester (812,354 pregnancies), the prevalence of polypharmacy ranged from 24.6% (2+ medications) to 0.1% (11+ medications). During the entire pregnancy period (774,247 pregnancies), the prevalence ranged from 58.7 to 1.4%. Broad-spectrum penicillin (6.6%), compound analgesics (4.5%) and treatment of candidiasis (4.3%) were commonly prescribed. Pairs of medication prescribed to manage different long-term conditions commonly included selective beta 2 agonists or selective serotonin re-uptake inhibitors (SSRIs). Risk factors for being prescribed 2+ medications during the first trimester of pregnancy include being overweight or obese [aOR: 1.16 (1.14-1.18) and 1.55 (1.53-1.57)], belonging to an ethnic minority group [aOR: 2.40 (2.33-2.47), 1.71 (1.65-1.76), 1.41 (1.35-1.47) and 1.39 (1.30-1.49) among women from South Asian, Black, other and mixed ethnicities compared to white women] and smoking or previously smoking [aOR: 1.19 (1.18-1.20) and 1.05 (1.03-1.06)]. Higher and lower age, higher gravidity, increasing number of comorbidities and increasing level of deprivation were also associated with increased odds of polypharmacy., Conclusions: The prevalence of polypharmacy during pregnancy has increased over the past two decades and is particularly high in younger and older women; women with high BMI, smokers and ex-smokers; and women with multimorbidity, higher gravidity and higher levels of deprivation. Well-conducted pharmaco-epidemiological research is needed to understand the effects of multiple medication use on the developing foetus., (© 2023. The Author(s).)

Objective(s): To understand current practice, expertise and training requirements for management of an impacted fetal head (IFH) at caesarean section (CS) in the UK, and whether a clinical trial of techniques to manage an IFH is acceptable., Study Design: Five hundred and thirty-eight online surveys were completed by obstetricians (n = 206), obstetric anaesthetists (n = 38), midwives (n = 35) and parents (n = 259). Data was collected on incidences of CS and IFH, current use of techniques, and acceptability of a clinical trial to manage an IFH from health care professionals. Information on incidences of CS and recollection of an IFH, acceptability of techniques, and likelihood of taking part in a clinical trial were sought from parents., Results: The most common technique used by obstetricians (84%) and midwives (69%) was the 'push technique'. Eighty-seven percent of health care professionals would be willing to participate in a clinical trial, with 89% confirming that results would guide their clinical practice. Most parents expressed reluctance regarding participation in a clinical trial during labour (62%), due to preferring a doctor to adopt the technique they felt most comfortable with (63%)., Conclusion(s): Given the lack of national guidance on appropriate techniques, no formal training, and no consensus on best practice for the management of an IFH during emergency CS, it is perhaps not surprising that the majority of heath care professionals would be willing to participate in a clinical trial, where results will guide their clinical practice. The future development of clinical trials, involving relevant stakeholders in the design of such trials, is crucial to improve upon the guidance and training provided to staff who may encounter an IFH., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Increasingly more pregnant women are living with pre-existing multimorbidity (≥two long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings., Methods and Analysis: We propose a four stage study design: (1) systematic literature search, (2) focus groups, (3) Delphi surveys and (4) consensus group meeting. The study will be conducted from June 2021 to August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted among (1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners) and (2) their healthcare/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include (1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, (2) healthcare/social care professionals involved in their care and (3) researchers in this field., Ethics and Dissemination: This study has been approved by the University of Birmingham's ethical review committee. The final COS will be disseminated through peer-reviewed publication and conferences and to all stakeholders., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: This study aimed to explore women's views on the acceptability of different techniques for managing an impacted fetal head at caesarean; and the feasibility and acceptability of conducting a trial in this area., Methods: Qualitative semi-structured interviews with a systematic sample of women who experienced second stage emergency caesarean section at a tertiary National Health Service (NHS) hospital in England, UK. Thematic analysis was used to extract women's views., Results: Women varied in their perceptions of the acceptability of different techniques for managing impacted fetal head. Trust in medical expertise and prioritising the safety of the baby were important contextual factors. Greater consensus was found around informed choice in trials where subthemes considered the timing of invitation, reduced capacity to give consent in emergency situations, and the importance of birth outcomes and having good rapport with healthcare professionals who invite women into trials. Finally, women reflected on the importance of supportive antenatal and postpartum education for impacted fetal head., Conclusions: This research provides information on the acceptability of techniques and any trial to evaluate these techniques. Findings illustrate the importance of context and quality of care to both acceptability and approaching women to take part in a future trial.

Introduction: Approximately 60 000 (9/100) infants are born into water annually in the UK and this is likely to increase. Case reports identified infants with water inhalation or sepsis following birth in water and there is a concern that women giving birth in water may sustain more complex perineal trauma. There have not been studies large enough to show whether waterbirth increases these poor outcomes. The POOL Study (ISRCTN13315580) plans to answer the question about the safety of waterbirths among women who are classified appropriate for midwifery-led intrapartum care., Methods and Analysis: A cohort study with a nested qualitative component. Objectives will be answered using retrospective and prospective data captured in electronic National Health Service (NHS) maternity and neonatal systems. The qualitative component aims to explore factors influencing pool use and waterbirth; data will be gathered via discussion groups, interviews and case studies of maternity units., Ethics and Dissemination: The protocol has been approved by NHS Wales Research Ethics Committee (18/WA/0291) the transfer of identifiable data has been approved by Health Research Authority Confidentiality Advisory Group (18CAG0153).Study findings and innovative methodology will be disseminated through peer-reviewed journals, conferences and events. Results will be of interest to the general public, clinical and policy stakeholders in the UK and will be disseminated accordingly., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Introduction: We report on service user participation in a population-based data linkage study designed to analyse the daily, weekly and yearly cycles of births in England and Wales, the outcomes for women and babies, and their implications for the NHS. Public Involvement and Engagement (PI&E) has a long history in maternity services, though PI&E in maternity data linkage studies is new in the United Kingdom. We have used the GRIPP2 short form, a tool designed for reporting public involvement in research., Objectives: We aimed to involve and engage a wide range of maternity service users and their representatives to ensure that our use of patient-identifiable routinely collected maternity and birth records was acceptable and that our research analyses using linked data were relevant to their expressed safety and quality of care needs., Methods: A three-tiered approach to PI&E was used. Having both PI&E co-investigators and PI&E members of the Study Advisory Group ensured service user involvement was part of the strategic development of the project. A larger constituency of maternity service users from England and Wales was engaged through four regional workshops., Results: Two co-investigators with experience of PI&E in maternity research were involved as service user researchers from design stage to dissemination. Four PI&E study advisors contributed service user perspectives. Engagement workshops attracted around 100 attendees, recruited largely from Maternity Services Liaison Committees in England and Wales, and a community engagement group. They supported the use of patient-identifiable data, believing the study had potential to improve safety and quality of maternity services. They contributed their experiences and concerns which will assist with interpretation of the analyses., Conclusion: Use of PI&E 'knowledge intermediaries' successfully bridged the gap between data intensive research and lived experience, but more inclusivity in involvement and engagement is required. Respecting the concerns and questions of service users provides social legitimacy and a relevance framework for researchers carrying out analyses.

Background: The setting in which induction of labour takes place (home or inpatient) is likely to have implications for safety, women's experiences and costs. Home induction may be started at home with the subsequent active phase of labour happening either at home or in a healthcare facility (hospital, birth centre, midwifery-led unit). More commonly, home induction starts in a healthcare facility, then the woman goes home to await the start of labour. Inpatient induction takes place in a healthcare facility where the woman stays while awaiting the start of labour., Objectives: To assess the effects on neonatal and maternal outcomes of third trimester home induction of labour compared with inpatient induction using the same method of induction., Search Methods: For this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (31 January 2020)), and reference lists of retrieved studies., Selection Criteria: Published and unpublished randomised controlled trials (RCTs) in which home and inpatient settings for induction have been compared. We included conference abstracts but excluded quasi-randomised trials and cross-over studies., Data Collection and Analysis: Two review authors independently assessed study reports for inclusion. Two review authors carried out data extraction and assessment of risk of bias independently. GRADE assessments were checked by a third review author., Main Results: We included seven RCTs, six of which provided data on 1610 women and their babies. Studies were undertaken between 1998 and 2015, and all were in high- or upper-middle income countries. Most women were induced for post dates. Three studies reported government funding, one reported no funding and three did not report on their funding source. Most GRADE assessments gave very low-certainty evidence, downgrading mostly for high risk of bias and serious imprecision. 1. Home compared to inpatient induction with vaginal prostaglandin E (PGE) (two RCTs, 1028 women and babies; 1022 providing data). Although women's satisfaction may be slightly better in home settings, the evidence is very uncertain (mean difference (MD) 0.16, 95% confidence interval (CI) -0.02 to 0.34, 1 study, 399 women), very low-certainty evidence. There may be little or no difference between home and inpatient induction for other primary outcomes, with all evidence being very low certainty: - spontaneous vaginal birth (average risk ratio (RR) [aRR] 0.91, 95% CI 0.69 to 1.21, 2 studies, 1022 women, random-effects method); - uterine hyperstimulation (RR 1.19, 95% CI 0.40 to 3.50, 1 study, 821 women); - caesarean birth (RR 1.01, 95% CI 0.81 to 1.28, 2 studies, 1022 women); - neonatal infection (RR 1.29, 95% CI 0.59 to 2.82, 1 study, 821 babies); - admission to neonatal intensive care unit (NICU) (RR 1.20, 95% CI 0.50 to 2.90, 2 studies, 1022 babies). Studies did not report serious neonatal morbidity or mortality. 2. Home compared to inpatient induction with controlled release PGE (one RCT, 299 women and babies providing data). There was no information on whether the questionnaire on women's satisfaction with care used a validated instrument, but the findings presented showed no overall difference in scores. We found little or no difference between the groups for other primary outcomes, all also being very low-certainty evidence: - spontaneous vaginal birth (RR 0.94, 95% CI 0.77 to 1.14, 1 study, 299 women); - uterine hyperstimulation (RR 1.01, 95% CI 0.51 to 1.98, 1 study, 299 women); - caesarean births (RR 0.95, 95% CI 0.64 to 1.42, 1 study, 299 women); - admission to NICU (RR 1.38, 0.57 to 3.34, 1 study, 299 babies). The study did not report on neonatal infection nor serious neonatal morbidity or mortality. 3. Home compared to inpatient induction with balloon or Foley catheter (four RCTs; three studies, 289 women and babies providing data). It was again unclear whether questionnaires reporting women's experiences/satisfaction with care were validated instruments, with one study (48 women, 69% response rate) finding women were similarly satisfied. Home inductions may reduce the number of caesarean births, but the data are also compatible with a slight increase and are of very low-certainty (RR 0.64, 95% CI 0.41 to 1.01, 2 studies, 159 women). There was little or no difference between the groups for other primary outcomes with all being very low-certainty evidence: - spontaneous vaginal birth (RR 1.04, 95% CI 0.54 to 1.98, 1 study, 48 women): - uterine hyperstimulation (RR 0.45, 95% CI 0.03 to 6.79, 1 study, 48 women); - admission to NICU (RR 0.37, 95% CI 0.07 to 1.86, 2 studies, 159 babies). There were no serious neonatal infections nor serious neonatal morbidity or mortality in the one study (involving 48 babies) assessing these outcomes., Authors' Conclusions: Data on the effectiveness, safety and women's experiences of home versus inpatient induction of labour are limited and of very low-certainty. Given that serious adverse events are likely to be extremely rare, the safety data are more likely to come from very large observational cohort studies rather than relatively small RCTs., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: The 'Surviving Crying' study was designed to develop and provisionally evaluate a support service for parents of excessively crying babies, including its suitability for use in the United Kingdom (UK) National Health Service (NHS). The resulting service includes three materials: a website, a printed booklet, and a Cognitive Behaviour Therapy (CBT) programme delivered to parents by a qualified professional. This study aimed to measure whether parents used the materials and to obtain parents' and NHS professionals' evaluations of whether they are fit for purpose. Parents were asked about participating in a randomised controlled trial (RCT) to evaluate the materials fully in health service use., Methods: Participants were 57 parents with babies they judged to be crying excessively and 96 NHS Health Visitors (HVs). Parental use and parents' and HVs' ratings of the Surviving Crying materials were measured., Results: Thirty four parents reported using the website, 24 the printed booklet and 24 the CBT sessions. Parents mostly accessed the website on mobile phones or tablets and use was substantial. All the parents and almost all HVs who provided data judged the materials to be helpful for parents and suitable for NHS use. If offered a waiting list control group, 85% of parents said they would have been willing to take part in a full RCT evaluation of the Surviving Crying package., Discussion and Conclusions: The findings identify the need for materials to support parents of excessively crying babies within national health services in the UK. The Surviving Crying support package appears suitable for this purpose and a full community-level RCT of the package is feasible and likely to be worthwhile. Limitations to the study and barriers to delivery of the services were identified, indicating improvements needed in future research., Trial Registration: Study Registration no. ISRCTN84975637 .

Background: Continuous electronic fetal monitoring (EFM) in labour is widely used and computerised interpretation has the potential to increase its utility., Objectives: This trial aimed to find out whether or not the addition of decision support software to assist in the interpretation of the cardiotocograph (CTG) reduced the number of poor neonatal outcomes, and whether or not it was cost-effective., Design: Two-arm individually randomised controlled trial. The allocations were computer generated using stratified block randomisation employing variable block sizes. The trial was not masked., Setting: Labour wards in England, Scotland and the Republic of Ireland., Participants: Women in labour having EFM, with a singleton or twin pregnancy, at ≥ 35 weeks' gestation., Interventions: Decision support or no decision support., Main Outcome Measures: The primary outcomes were (1) a composite of poor neonatal outcome {intrapartum stillbirth or early neonatal death (excluding lethal congenital anomalies), or neonatal morbidity [defined as neonatal encephalopathy (NNE)], or admission to a neonatal unit within 48 hours for ≥ 48 hours (with evidence of feeding difficulties, respiratory illness or NNE when there was evidence of compromise at birth)}; and (2) developmental assessment at the age of 2 years in a subset of surviving children., Results: Between 6 January 2010 and 31 August 2013, 47,062 women were randomised and 46,042 were included in the primary analysis (22,987 in the decision support group and 23,055 in the no decision support group). The short-term primary outcome event rate was higher than anticipated. There was no evidence of a difference in the incidence of poor neonatal outcome between the groups: 0.7% ( n  = 172) of babies in the decision support group compared with 0.7% ( n  = 171) of babies in the no decision support group [adjusted risk ratio 1.01, 95% confidence interval (CI) 0.82 to 1.25]. There was no evidence of a difference in the long-term primary outcome of the Parent Report of Children's Abilities-Revised with a mean score of 98.0 points [standard deviation (SD) 33.8 points] in the decision support group and 97.2 points (SD 33.4 points) in the no decision support group (mean difference 0.63 points, 95% CI -0.98 to 2.25 points). No evidence of a difference was found for health resource use and total costs. There was evidence that decision support did change practice (with increased fetal blood sampling and a lower rate of repeated alerts)., Limitations: Staff in the control group may learn from exposure to the decision support arm of the trial, resulting in improved outcomes in the control arm. This was identified in the planning stage and felt to be unlikely to have a significant effect on the results. As this was a pragmatic trial, the response to CTG alerts was left to the attending clinicians., Conclusions: This trial does not support the hypothesis that the use of computerised interpretation of the CTG in women who have EFM in labour improves the clinical outcomes for mothers or babies., Future Work: There continues to be an urgent need to improve knowledge and training about the appropriate response to CTG abnormalities, including timely intervention., Trial Registration: Current Controlled Trials ISRCTN98680152., Funding: This project was funded by the National Institute for Health Research (NIHR) HTA programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 9. See the NIHR Journals Library website for further project information. Sara Kenyon was part funded by the NIHR Collaboration for Leadership in Applied Health Research and Care West Midlands.

Maternity services liaison committees (MSLCs) have a long history but were affected by 2013 health reforms. An online survey of heads of midwifery (HoMs) and service users was conducted to assess how many NHS trusts in England had a functioning MSLC and whether they were supported by clinical commissioning groups (CCGs) and working with Healthwatch, the new statutory consumer advocate. Results showed that at least 62 per cent of trusts had an MSLC. However, support from commissioners varied widely. Around two fifths of MSLCs had administrative support provided by the CCG or their local NHS trust. One in eight MSLCs had a budget including an allowance for the Chair. Some MSLCs were struggling to continue, due to little or no support. Both HoMs and service users wanted commissioners to provide more consistent support for MSLCs. One in five MSLCs had a clear link with Healthwatch. This is a legacy to underpin the transition to CCG-funded MaternityVoices Partnerships in 2017.

BACKGROUND There is a growing body of evidence that safe outcomes and quality care are important to patients. For the patient, evaluations of safety and quality are made on the basis of the interpersonal interactions that they have with health professionals as well as the technical aspects of their care. OBJECTIVE In this study, we investigated the extent to which outcome of care (harm or not) and relationship (good or bad) with the care provider impact on the judgements of responsibility and blame as well as decisions about likelihood of making a complaint. METHOD Ninety-eight mothers made seven ratings of responsibility, blame and action in response to four hypothetical vignettes in a questionnaire. The vignettes described poor quality ante-natal care in which outcome and relationship with the health-care provider were systematically manipulated across different versions of the questionnaire. RESULTS Multivariate analyses showed that participants made significantly more negative ratings in response to vignettes describing a bad outcome and those that described a poor relationship with the health professional. However, whilst ratings of seriousness and likelihood of making a complaint were most influenced by the manipulation of outcome in the vignettes, judgements of blame and responsibility were most effected by the depiction of relationship with the health professional as good or bad. Moreover, for three of the four vignettes, relationship rather than outcome most strongly influenced overall ratings of care. DISCUSSION These findings are discussed in the context of theory and policy developments., (© 2010 Blackwell Publishing Ltd.)