Women's and clinicians perspectives of presentation with reduced fetal movements: a qualitative study.

BACKGROUND: Worldwide maternal perception of fetal movements has been used for many years to evaluate fetal wellbeing. It is intuitively regarded as an expression of fetal well-being as pregnancies in which women consistently report regular fetal movements have very low morbidity and mortality. Conversely, maternal perception of reduced fetal movements is associated with adverse pregnancy outcomes. We sought to gain insight into pregnant women's and clinicians views and experiences of reduced movements. METHOD: We performed qualitative semi-structured interviews with pregnant women who experienced reduced fetal movements in their current pregnancy and health professionals who provide maternity care. Our aim was to develop a better understanding of events, facilitators and barriers to presentation with reduced fetal movements. Data analysis was conducted using framework analysis principles. RESULTS: Twenty-one women and 10 clinicians were interviewed. The themes that emerged following the final coding were influences of social network, facilitators and barriers to presentation and the desire for normality. CONCLUSIONS: This study aids understanding about why women present with reduced movements and how they reach the decision to attend hospital. This should inform professionals' views and practice, such that appreciating and addressing women's concerns may reduce anxiety and make presentation with further reduced movements more likely, which is desirable as this group is at increased risk of adverse outcome. To address problems with information about normal and abnormal fetal movements, high-quality information is needed that is accessible to women and their families.

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists.

OBJECTIVES: To provide information on the frequency and reasons for outcome reporting bias in clinical trials. DESIGN: Trial protocols were compared with subsequent publication(s) to identify any discrepancies in the outcomes reported, and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes. PARTICIPANTS: Chief investigators, or lead or coauthors of trials, were identified from two sources: trials published since 2002 covered in Cochrane systematic reviews where at least one trial analysed was suspected of being at risk of outcome reporting bias (issue 4, 2006; issue 1, 2007, and issue 2, 2007 of the Cochrane library); and a random sample of trial reports indexed on PubMed between August 2007 and July 2008. SETTING: Australia, Canada, Germany, the Netherlands, New Zealand, the United Kingdom, and the United States. MAIN OUTCOME MEASURES: Frequency of incomplete outcome reporting-signified by outcomes that were specified in a trial's protocol but not fully reported in subsequent publications-and trialists' reasons for incomplete reporting of outcomes. RESULTS: 268 trials were identified for inclusion (183 from the cohort of Cochrane systematic reviews and 85 from PubMed). Initially, 161 respective investigators responded to our requests for interview, 130 (81%) of whom agreed to be interviewed. However, failure to achieve subsequent contact, obtain a copy of the study protocol, or both meant that final interviews were conducted with 59 (37%) of the 161 trialists. Sixteen trial investigators failed to report analysed outcomes at the time of the primary publication, 17 trialists collected outcome data that were subsequently not analysed, and five trialists did not measure a prespecified outcome over the course of the trial. In almost all trials in which prespecified outcomes had been analysed but not reported (15/16, 94%), this under-reporting resulted in bias. In nearly a quarter of trials in which prespecified outcomes had been measured but not analysed (4/17, 24%), the "direction" of the main findings influenced the investigators' decision not to analyse the remaining data collected. In 14 (67%) of the 21 randomly selected PubMed trials, there was at least one unreported efficacy or harm outcome. More than a quarter (6/21, 29%) of these trials were found to have displayed outcome reporting bias. CONCLUSION: The prevalence of incomplete outcome reporting is high. Trialists seemed generally unaware of the implications for the evidence base of not reporting all outcomes and protocol changes. A general lack of consensus regarding the choice of outcomes in particular clinical settings was evident and affects trial design, conduct, analysis, and reporting.

Amniotomy for shortening spontaneous labour.

BACKGROUND: Intentional artificial rupture of the amniotic membranes during labour, sometimes called amniotomy or 'breaking of the waters', is one of the most commonly performed procedures in modern obstetric and midwifery practice. The primary aim of amniotomy is to speed up contractions and, therefore, shorten the length of labour. However, there are concerns regarding unintended adverse effects on the woman and baby. OBJECTIVES: To determine the effectiveness and safety of amniotomy alone for (1) routinely shortening all labours that start spontaneously, and (2) shortening labours that have started spontaneously, but have become prolonged. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 March 2007). SELECTION CRITERIA: Randomised controlled trials comparing amniotomy alone versus intention to preserve the membranes. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two authors assessed identified studies for inclusion. Both authors extracted data. Primary analysis was by intention to treat. MAIN RESULTS: We have included 14 studies in this review, involving 4893 women. There was no evidence of any statistical difference in length of first stage of labour (weighted mean difference -20.43 minutes, 95% confidence interval (CI) -95.93 to 55.06), maternal satisfaction with childbirth experience (standardised mean difference 0.27, 95% CI -0.49 to 1.04) or low Apgar score less than seven at five minutes (RR 0.55, 95% CI 0.29 to 1.05). Amniotomy was associated with an increased risk of delivery by caesarean section compared to women in the control group, although the difference was not statistically significant (RR 1.26, 95% CI 0.98 to 1.62). There was no consistency between papers regarding the timing of amniotomy during labour in terms of cervical dilatation. AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend that amniotomy should be introduced routinely as part of standard labour management and care. We do recommend that the evidence presented in this review should be made available to women offered an amniotomy and may be useful as a foundation for discussion and any resulting decisions made between women and their caregivers.