Optimizing cord management for each preterm baby - Challenges of collating individual participant data and recommendations for future collaborative research.

The optimal cord management strategy at birth for each preterm baby is still unknown, despite more than 100 randomized controlled trials (RCTs) undertaken on this question. To address this, we brought together all RCTs examining cord management strategies at preterm birth in the iCOMP (individual participant data on COrd Management at Preterm birth) Collaboration, to perform an individual participant data network meta-analysis. In this paper, we describe the trials and tribulations around obtaining individual participant data to resolve controversies around cord clamping, and we derive key recommendations for future collaborative research in perinatology.

Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy-the MILO Study.

Background: Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency.

Top research priorities for preterm birth: results of a prioritisation partnership between people affected by preterm birth and healthcare professionals.

Background: We report a process to identify and prioritise research questions in preterm birth that are most important to people affected by preterm birth and healthcare practitioners in the United Kingdom and Republic of Ireland.

Methods: Using consensus development methods established by the James Lind Alliance, unanswered research questions were identified using an online survey, a paper survey distributed in NHS preterm birth clinics and neonatal units, and through searching published systematic reviews and guidelines. Prioritisation of these questions was by online voting, with paper copies at the same NHS clinics and units, followed by a decision-making workshop of people affected by preterm birth and healthcare professionals.

Evaluation of expressive writing for postpartum health: a randomised controlled trial.

Pregnancy, birth and adjusting to a new baby is a potentially stressful time that can negatively affect the health of women. There is some evidence that expressive writing can have positive effects on psychological and physical health, particularly during stressful periods. The current study aimed to evaluate whether expressive writing would improve women's postpartum health.

Feasibility and acceptability of expressive writing with postpartum women: a randomised controlled trial.

Background: Pregnancy, birth and adjusting to a new baby is a potentially stressful time that can negatively affect women's mental and physical health. Expressive writing, where people write about a stressful event for at least 15 min on three consecutive days, has been associated with improved health in some groups but it is not clear whether it is feasible and acceptable for use with postpartum women. This study therefore examined the feasibility and acceptability of expressive writing for postpartum women as part of a randomised controlled trial (RCT).

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) 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 the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials?

Methods: In a systematic search, we identified 30 studies.

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project.

Background: The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe.

Methods: Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence.

Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial.

Background: Preterm birth is the most important single determinant of adverse outcome in the United Kingdom; one in every 70 babies (1.4%) is born before 32 weeks (very preterm), yet these births account for over half of infant deaths.Deferring cord clamping allows blood flow between baby and placenta to continue for a short time.

Public involvement in setting a national research agenda: a mixed methods evaluation.

Background: : A growing body of literature supports the inclusion of patients, other service users, and the wider public in guiding health technology assessment, particularly in relation to interventions and outcomes for evaluative studies.

Objective: : To describe the input and influence of public involvement in setting the agenda for a national research program.

Methods: : The data source was the commissioned research of the UK National Health Service Health Technology Assessment (HTA) program, 1999-2004.

A multidimensional conceptual framework for analysing public involvement in health services research.

Objective: To describe the development of a multidimensional conceptual framework capable of drawing out the implications for policy and practice of what is known about public involvement in research agenda setting.

Background: Public involvement in research is growing in western and developing countries. There is a need to learn from collective experience and a diverse literature of research, policy documents and reflective reports.

Use of recombinant activated factor VII in primary postpartum hemorrhage: the Northern European registry 2000-2004.

Objective: To collect data from nine European countries for cases of obstetric hemorrhage between 2000 and 2004 in which recombinant activated factor VII (rFVIIa) was used.

Methods: The cases were identified through national surveys. Standardized case report forms included sociodemographic details, past medical and obstetric history, and details of the progress and management of labor in which the postpartum hemorrhage occurred.

Achieving sustainable quality in maternity services - using audit of incontinence and dyspareunia to identify shortfalls in meeting standards.

BACKGROUND: Some complications of childbirth (for example, faecal incontinence) are a source of social embarrassment for women, and are often under reported. Therefore, it was felt important to determine levels of complications (against established standards) and to consider obstetric measures aimed at reducing them. METHODS: Clinical information was collected on 1036 primiparous women delivering at North and South Staffordshire Acute and Community Trusts over a 5-month period in 1997.