Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study.

OBJECTIVE: To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of postpartum haemorrhage (PPH), and recommendations on how to report the COS. DESIGN: A two-round Delphi survey and face-to-face meeting. POPULATION: Healthcare professionals and women's representatives. METHODS: Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes. MAIN OUTCOME MEASURES: Outcomes from systematic reviews and consultations. RESULTS: Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. Recommendations were developed on how to report these outcomes where possible. CONCLUSIONS: These COS will help standardise outcome reporting in PPH trials. TWEETABLE ABSTRACT: Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.

BACKGROUND: Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet approaching parents at this difficult time raises challenges for the obtaining of valid informed consent to such research. This study asked: what light does the empirical literature cast on an ethically defensible approach to the obtaining of informed consent in perinatal clinical trials? METHODS: A systematic search identified 49 studies. Analysis began by applying philosophical frameworks which were then refined in light of the concepts emerging from empirical studies to present a coherent picture of a broad literature. RESULTS: Between them, studies addressed the attitudes of both parents and clinicians concerning consent in neonatal trials; the validity of the consent process in the neonatal research context; and different possible methods of obtaining consent. CONCLUSIONS: Despite a variety of opinions among parents and clinicians there is a strongly and widely held view that it is important that parents do give or decline consent for neonatal participation in trials. However, none of the range of existing consent processes reviewed by the research is satisfactory. A significant gap is evaluation of the widespread practice of emergency 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to ongoing participation and follow-up. Emergency assent has not been evaluated for its acceptability, how such a process would deal with bad outcomes such as neonatal death between assent and consent, or the extent to which late parental refusal might bias results. This review of a large number of empirical papers, while not making fundamental changes, has refined and developed the conceptual framework from philosophy for examining informed consent in this context.

Self-hypnosis for intrapartum pain management in pregnant nulliparous women: a randomised controlled trial of clinical effectiveness.

OBJECTIVE: (Primary) To establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use. DESIGN: Multi-method randomised control trial (RCT). SETTING: Three NHS Trusts. POPULATION: Nulliparous women not planning elective caesarean, without medication for hypertension and without psychological illness. METHODS: Randomisation at 28-32 weeks' gestation to usual care, or to usual care plus brief self-hypnosis training (two × 90-minute groups at around 32 and 35 weeks' gestation; daily audio self-hypnosis CD). Follow up at 2 and 6 weeks postnatal. MAIN OUTCOME MEASURES: Primary: epidural analgesia. Secondary: associated clinical and psychological outcomes; cost analysis. RESULTS: Six hundred and eighty women were randomised. There was no statistically significant difference in epidural use: 27.9% (intervention), 30.3% (control), odds ratio (OR) 0.89 [95% confidence interval (CI): 0.64-1.24], or in 27 of 29 pre-specified secondary clinical and psychological outcomes. Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and 2 weeks post natal (anxiety: mean difference -0.72, 95% CI -1.16 to -0.28, P = 0.001); fear (mean difference -0.62, 95% CI -1.08 to -0.16, P = 0.009) [Correction added on 7 July 2015, after first online publication: 'Mean difference' replaced 'Odds ratio (OR)' in the preceding sentence.]. Postnatal response rates were 67% overall at 2 weeks. The additional cost in the intervention arm per woman was £4.83 (CI -£257.93 to £267.59). CONCLUSIONS: Allocation to two-third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables. The impact of women's anxiety and fear about childbirth needs further investigation.

Measuring parents' experiences and satisfaction with care during very preterm birth: a questionnaire development study.

OBJECTIVE: To develop a questionnaire to assess parents' experiences and satisfaction with care during very preterm birth. DESIGN: Questionnaire development. SETTING: Parents whose babies had been cared for at five tertiary neonatal units in England. POPULATION: A total of 145 women who gave birth before 32 weeks of gestation, and 85 of their partners. METHODS: A 30-item questionnaire was developed on the basis of qualitative interviews with parents of very preterm babies, a literature review and discussion with relevant experts. The questionnaire was posted to a second group of parents, and its reliability and validity were explored. MAIN OUTCOME MEASURES: The Preterm Birth Experience and Satisfaction Scale (P-BESS) was correlated with two global questions measuring satisfaction with care during the birth. Internal consistency was measured using Cronbach's α. RESULTS: Parents of 458 babies were invited to take part and 147 (32%) responded. Two women and 22 partners were excluded or ineligible, leaving 145 women and 85 partners. Factor analysis produced three clear dimensions: Staff professionalism and empathy, Information and explanations, and Confidence in staff. The total scale and three subscales showed high reliability. Strong positive correlations were found between the questionnaire scales and the two global questions, indicating convergent validity. For women whose partners were present at the birth, a fourth factor was identified 'Partner Involvement'. CONCLUSIONS: The P-BESS appears to be a valid measure of satisfaction with care during very preterm birth.

Parents' experiences and satisfaction with care during the birth of their very preterm baby: a qualitative study.

OBJECTIVE: To assess parents' experiences and satisfaction with care during very preterm birth and to identify domains associated with positive and negative experiences of care. DESIGN: Qualitative study using semi-structured interviews. SETTING: Three neonatal units in tertiary care hospitals in South-East England. POPULATION: Thirty-two mothers and seven fathers who had a baby born before 32 weeks of gestation and spoke English well. METHODS: Semi-structured interviews were conducted. Results were analysed using thematic analysis. MAIN OUTCOME MEASURES: Participants' experiences and satisfaction with care during the birth of their preterm baby. RESULTS: Overall, 80% of participants were extremely satisfied with the care during the birth of their preterm baby, seven were generally satisfied but felt some things could be improved and one was dissatisfied. Four key determinants of experiences of care were identified: staff professionalism, which included information and explanation, being calm in a crisis, appearing confident and in control, and conversely not listening to the woman; staff empathy, which included caring and emotional support, and encouragement and reassurance; involvement of the father; and birth environment. CONCLUSIONS: Although the determinants of experiences of care are generally consistent with previous research on term births, unique factors to preterm birth were identified. These were the importance of the staff appearing calm during the birth, and the staff portraying confidence and taking control during the birth. Women valued being listened to, and both they and their partners valued staff helping fathers to feel involved during the birth.

Interventions at caesarean section for reducing the risk of aspiration pneumonitis.

BACKGROUND: Various interventions are used as prophylaxis for aspiration pneumonitis in obstetric anaesthesia. This review, based on a Cochrane systematic review currently being updated, examines whether interventions given before caesarean section reduce the risk of aspiration pneumonitis. METHODS: Twenty-two studies, involving 2658 women providing data in a usable format for meta-analysis were identified. RESULTS: Compared to no treatment or placebo, there was a significant reduction in the risk of intra-gastric pH <2.5 with antacids (risk ratio (RR) 0.17, 95% confidence interval (CI) 0.09-0.32), H2 antagonists (RR 0.09, 95% CI 0.05-0.18) and proton-pump antagonists (RR 0.26, 95% CI 0.14-0.46). H2 antagonists were associated with a reduced risk of intra-gastric pH <2.5 when compared with proton-pump antagonists (RR 0.39, 95% CI 0.16-0.97), but compared with antacids the findings were unclear. Combined use of antacids plus H2 antagonists was associated with a significant reduction in the risk of intra-gastric pH <2.5 when compared with placebo (RR 0.02, 95% CI 0.00-0.15) or compared with antacids alone (RR 0.12, 95% CI 0.02-0.92). CONCLUSION: The quality of evidence was weak and may not reflect a reduction in the risk of aspiration pneumonitis since none of the studies assessed substantive clinical outcomes or potential adverse effects. Further work is required to validate the suitability of surrogate markers of pH and gastric volume for clinical outcomes in the context of aspiration pneumonitis.

Estimating intrapartum-related perinatal mortality rates for booked home births: when the 'best' available data are not good enough.

OBJECTIVE: To critically appraise a recent study on the safety of home birth (Mori R, Dougherty M, Whittle M. BJOG 2008;115:554) and assess its contribution to the debate about risks and benefits of planned home birth for women at low risk of complications. DESIGN: Critical appraisal of a published paper. SETTING: England and Wales. POPULATION OR SAMPLE: Home births from 1994-2003 and all women giving birth in the same time period. METHODS: Six members of a multidisciplinary group appraised the paper independently. Comments were collated and synthesised. MAIN OUTCOME MEASURES: Assessment of: overall methodology; assumptions used in estimating figures; methods used for calculations; conclusions drawn from the results and reliability and consistency of data. RESULTS: Although there were some positive aspects to the study, there were weaknesses in design and an inaccurate estimate of risk. Our evidence suggests that the conclusions drawn did not reflect the results and the methodological weaknesses found in the study rendered both the results and conclusions invalid. CONCLUSIONS: On the basis of our critical appraisal, the study does not contribute to the existing evidence about the safety of home birth to inform decision-making or provision of care. The limitations could have been identified by the peer review process and the problems were compounded by an inaccurate press release. Great care needs to be taken by journals to ensure the accuracy of information before dissemination to the scientific community, clinicians and the public. These data should not have been used to inform national guidelines.

Choice and birth method: mixed-method study of caesarean delivery for maternal request.

OBJECTIVE: To explore whether women view decision-making surrounding vaginal or caesarean birth as their choice. DESIGN: Longitudinal cohort study utilising quantitative (questionnaire, routinely collected data) and qualitative (in-depth interviews) methods simultaneously. SETTING: A large hospital providing National Health Service maternity care in the UK. SAMPLE: Four-hundred and fifty-four primigravid women. METHODS: Women completed up to three questionnaires between their antenatal booking appointment and delivery. Amongst these women, 153 were interviewed at least once during pregnancy (between 24 and 36 weeks) and/or after 12 moths after birth. Data were also obtained from women's hospital delivery records. Descriptive statistical analysis was performed (survey and delivery data). Interview data were analysed using a seven-stage sequential form of qualitative analysis. RESULTS: Whilst many women supported the principle of choice, they identified how, in practice their autonomy was limited by individual circumstance and available care provision. All women felt that concerns about their baby's or their own health should take precedence over personal preference. Moreover, expressing a preference for either vaginal or caesarean birth was inherently problematic as choice until the time of delivery was neither static nor final. Women did not have autonomous choice over their actual birth method, but neither did they necessarily want it. CONCLUSIONS: The results of this large exploratory study suggest that choice may not be the best concept through which to approach the current arrangements for birth in the UK. Moreover, they challenge the notion of choice that currently prevails in international debates about caesarean delivery for maternal request.

Treatments for iron-deficiency anaemia in pregnancy.

BACKGROUND: Iron deficiency, the most common cause of anaemia in pregnancy worldwide, can be mild, moderate or severe. Severe anaemia can have very serious consequences for mothers and babies, but there is controversy about whether treating mild or moderate anaemia provides more benefit than harm. OBJECTIVES: To assess the effects of different treatments for iron-deficiency anaemia in pregnancy (defined as haemoglobin less than 11 g/dl) on maternal and neonatal morbidity and mortality. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 4), MEDLINE (1966 to December 2005), EMBASE (1976 to December 2005), LILACS (1982 to 40 edition), BIOSIS Previews (1980 to June 2002) and ongoing clinical trial registers. SELECTION CRITERIA: Randomised controlled trials comparing treatments for iron-deficiency anaemia in pregnancy. DATA COLLECTION AND ANALYSIS: We identified 17 trials, involving 2578 women. We assessed trial quality. MAIN RESULTS: The trials were small and generally methodologically poor. They covered a very wide range of differing drugs, doses and routes of administration, making it difficult to pool data. Oral iron in pregnancy showed a reduction in the incidence of anaemia (one trial, 125 women; relative risk 0.38; 95% confidence interval 0.26 to 0.55). It was not possible to assess the effects of treatment by severity of anaemia. A trend was found between dose and reported adverse effects. We found that most trials had no assessments on relevant clinical outcomes and a paucity of data on adverse effects, including some that are known to be associated with iron administration. Although the intramuscular and intravenous routes produced better haematological indices in women than the oral route, no clinical outcomes were assessed and there were insufficient data on adverse effects, for example, on venous thrombosis and severe allergic reactions. AUTHORS' CONCLUSIONS: Despite the high incidence and burden of disease associated with this condition, there is a paucity of good quality trials assessing clinical maternal and neonatal effects of iron administration in women with anaemia. Daily oral iron treatment improves haematological indices but causes frequent gastrointestinal adverse effects. Parenteral (intramuscular and intravenous) iron enhances haematological response, compared with oral iron, but there are concerns about possible important adverse effects. Large, good quality trials, assessing clinical outcomes (including adverse effects) are required.

Caesarean section for non-medical reasons at term.

BACKGROUND: Caesarean section rates are progressively rising in many parts of the world. One suggested reason is increasing requests by women for caesarean section in the absence of clear medical indications, such as placenta praevia, HIV infection, contracted pelvis and, arguably, breech presentation or previous caesarean section. The reported benefits of planned caesarean section include greater safety for the baby, less pelvic floor trauma for the mother, avoidance of labour pain and convenience. The potential disadvantages, from observational studies, include increased risk of major morbidity or mortality for the mother, adverse psychological sequelae, and problems in subsequent pregnancies, including uterine scar rupture and greater risk of stillbirth and neonatal morbidity. An unbiased assessment of advantages and disadvantages would assist discussion of what has become a contentious issue in modern obstetrics. OBJECTIVES: To assess, from randomised trials, the effects on perinatal and maternal morbidity and mortality, and on maternal psychological morbidity, of planned caesarean delivery versus planned vaginal birth in women with no clear clinical indication for caesarean section. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December 2005), MEDLINE (1974 to April 2005), EMBASE (1974 to April 2005), CINAHL (1982 to April 2005) and PsycINFO (1887 to April 2005). We also performed a manual search of the references of all retrieved articles, sought unpublished papers and abstracts submitted to international conferences and contacted expert informants. SELECTION CRITERIA: All comparisons of intention to perform caesarean section and intention for women to give birth vaginally; random allocation to treatment and control groups; adequate allocation concealment; women at term with single fetuses with cephalic presentations and no clear medical indication for caesarean section. DATA COLLECTION AND ANALYSIS: We identified no studies that met the inclusion criteria. MAIN RESULTS: There were no included trials. AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials, upon which to base any practice recommendations regarding planned caesarean section for non-medical reasons at term. In the absence of trial data, there is an urgent need for a systematic review of observational studies and a synthesis of qualitative data to better assess the short- and long-term effects of caesarean section and vaginal birth.

Routine prophylactic drugs in normal labour for reducing gastric aspiration and its effects.

BACKGROUND: Women in normal labour may sometimes go on to have general anaesthesia if labour becomes abnormal, for example if a caesarean section is required. General anaesthesia carries a very small risk of regurgitation and inhalation of stomach contents into the lungs. This can cause inflammation, particularly if the fluid is acidic, and can lead to severe morbidity and very occasionally mortality. Labour hormones increase the risk of gastric aspiration or Mendelsohn's syndrome, though the exact incidence is unknown. The routine administration of acid prophylaxis drugs to all women in normal labour is commonly practiced worldwide, to reduce gastric aspiration by reducing the volume and acidity of stomach contents. OBJECTIVES: To assess the effectiveness of routine prophylaxis drugs for women in normal labour to reduce gastric aspiration and its effects. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (December 2005), EMBASE (1974 to April 2005) and CINAHL (1982 to April 2005). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of women in normal labour assessing the routine administration of drugs (antacids, H(2) receptor antagonists, dopamine antagonists and proton-pump inhibitors) compared with placebo/no treatment, and compared with other drugs for reducing gastric aspiration. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed eligibility, quality, extracted data and performed double-data entry. MAIN RESULTS: Three trials were included, involving 2465 women, assessing the effects of antacids, H(2) receptor antagonists and dopamine antagonists. There were no trials on proton-pump inhibitors. None of the trials were of good quality, and none assessed the incidence of gastric aspiration, Mendelsohn's syndrome or their consequences. All the studies assessed vomiting, and there was limited evidence that vomiting may be reduced by antacids (relative risk (RR) 0.46, 95% confidence interval (CI) 0.27 to 0.77, n = 578, one trial) or by dopamine antagonists given alongside pethidine (RR 0.40, 95% CI 0.23 to 0.68, n = 584, one trial). Comparisons between different drugs showed no significant differences, though the number of participants was small. There was no evidence that H(2) receptor antagonists improved outcomes compared with antacids, though only one trial addressed this issue. AUTHORS' CONCLUSIONS: There is no good evidence to support the routine administration of acid prophylaxis drugs in normal labour to prevent gastric aspiration and its consequences. Giving such drugs to women once a decision to give general anaesthesia is made, is assessed in another Cochrane review.

Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour.

BACKGROUND: Cardiotocography (sometimes known as electronic fetal monitoring), records changes in the fetal heart rate and their temporal relationship to uterine contractions. The aim is to identify babies who may be short of oxygen (hypoxic), so additional assessments of fetal well-being may be used, or the baby delivered by caesarean section or instrumental vaginal birth. OBJECTIVES: To evaluate the effectiveness of continuous cardiotocography during labour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (March 2006), CENTRAL (The Cochrane Library 2005, Issue 4), MEDLINE (1966 to December 2005), EMBASE (1974 to December 2005), Dissertation Abstracts (1980 to December 2005) and the National Research Register (December 2005). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of continuous cardiotocography (with and without fetal blood sampling) with (a) no fetal monitoring, (b) intermittent auscultation (c) intermittent cardiotocography. DATA COLLECTION AND ANALYSIS: Two authors independently assessed eligibility, quality and extracted data. MAIN RESULTS: Twelve trials were included (over 37,000 women); only two were high quality. Compared to intermittent auscultation, continuous cardiotocography showed no significant difference in overall perinatal death rate (relative risk (RR) 0.85, 95% confidence interval (CI) 0.59 to 1.23, n = 33,513, 11 trials), but was associated with a halving of neonatal seizures (RR 0.50, 95% CI 0.31 to 0.80, n = 32,386, nine trials) although no significant difference was detected in cerebral palsy (RR 1.74, 95% CI 0.97 to 3.11, n = 13,252, two trials). There was a significant increase in caesarean sections associated with continuous cardiotocography (RR 1.66, 95% CI 1.30 to 2.13, n =18,761, 10 trials). Women were also more likely to have an instrumental vaginal birth (RR 1.16, 95% CI 1.01 to 1.32, n = 18,151, nine trials). Data for subgroups of low-risk, high-risk, preterm pregnancies and high quality trials were consistent with overall results. Access to fetal blood sampling did not appear to influence the difference in neonatal seizures nor any other prespecified outcome. AUTHORS' CONCLUSIONS: Continuous cardiotocography during labour is associated with a reduction in neonatal seizures, but no significant differences in cerebral palsy, infant mortality or other standard measures of neonatal well-being. However, continuous cardiotocography was associated with an increase in caesarean sections and instrumental vaginal births. The real challenge is how best to convey this uncertainty to women to enable them to make an informed choice without compromising the normality of labour.

Involving consumers in research and development agenda setting for the NHS: developing an evidence-based approach.

OBJECTIVES: To look at the processes and outcomes of identification and prioritisation in both national and regional R&D programmes in health and elsewhere, drawing on experiences of success and failure. Also to identify the barriers to, and facilitators of, meaningful participation by consumers in research identification and prioritisation. DATA SOURCES: Electronic databases and interviews with UK consumers and research programme managers. REVIEW METHODS: A framework was devised for examining the diverse ways of involving consumers in research. It identified key distinguishing features as: the types of consumers involved; whether consumers or researchers initiated the involvement; the degree of consumer involvement (consultation, collaboration or consumer control); forums for communication (e.g. committees, surveys, focus groups); methods for decision-making; and the practicalities for implementation. Context (institutional, geographical and historical setting) and underpinning theories were considered as important variables for analysing examples of consumer involvement. This innovative framework was then applied to the review data from reports selected for inclusion and interviews. RESULTS: The study found 286 documents explicitly mentioning consumer involvement in identifying or prioritising research topics. Of these, 91 were general discussions, some of which included a theoretical analysis or a critique of research agendas from a consumer perspective, 160 reported specific efforts to include consumers in identifying or prioritising research topics and a further 51 reported consumers identifying or prioritising research topics in the course of other work. Detailed reports of 87 specific examples were identified. Most of this literature was descriptive reports by researchers who were key actors in involving consumers. A few reports were written by consumer participants. Fewer still were by independent researchers. Our conclusions are therefore not based on rigorous research, but implications for policy are drawn from individual reports and comparative analyses. CONCLUSIONS: Productive methods for involving consumers require appropriate skills, resources and time to develop and follow appropriate working practices. The more that consumers are involved in determining how this is to be done, the more research programmes will learn from consumers and about how to work with them. Further success might be expected if research programmes embarking on collaborations approach well-networked consumers and provide them with information, resources and support to empower them in key roles for consulting their peers and prioritising topics. To be worthwhile, consultations should engage consumer groups directly and repeatedly in facilitated debate; when discussing health services research, more resources and time are required if consumers are drawn from groups whose main focus of interest is not health. These barriers can largely be overcome with good leadership, purposeful outreach to consumers, investing time and effort in good communication, training and support and thereby building good working relationships and building on experience. Organised consumer groups capable of identifying research priorities also need to find ways of introducing their ideas into research programmes. Further research is suggested to develop and evaluate different training methods, information and education and other support for consumers and those wishing to involve them; to address the barriers to consumers' ideas influencing research agendas; and to carry out prospective comparative studies of different methods for involving consumers. Research about collective decision-making would also be further advanced by addressing the processes and outcomes of consensus development that involves consumers.