Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study.

Objective: Trial legislation enables research to be conducted without prior consent (RWPC) in emergency situations, yet this approach has rarely been used in time-critical obstetric trials. This study explored views and experiences of antenatal recruitment and consent and RWPC in an emergency intrapartum randomised clinical trial.

Design: Embedded, mixed-methods study within a trial, involving questionnaires, recorded recruitment discussions, interviews and focus groups in the first 13 months of trial recruitment (December 2020-January 2022).

COHESION: a core outcome set for the treatment of neonatal encephalopathy.

Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis.

Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial.

Background: Delphi surveys are commonly used to prioritise critical outcomes in core outcome set (COS) development. This trial aims to compare a three-round (Multi-Round) Delphi (MRD) with a Real-Time Delphi (RTD) in the prioritisation of outcomes for inclusion in a COS for neonatal encephalopathy treatments and explore whether 'feedback', 'iteration', and 'initial condition' effects may occur in the two survey methods.

Methods: We recruited 269 participants (parents/caregivers, healthcare providers and researchers/academics) of which 222 were randomised to either the MRD or the RTD.

Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage.

Background: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.

Methods: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery.

Core outcomes in neonatal encephalopathy: a qualitative study with parents.

Objective: To identify the outcomes considered important to parents or caregivers of infants diagnosed with neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia in high-income and low- to middle-income countries (LMiCs), as part of the outcome-identification process in developing a core outcome set (COS) for the treatment of neonatal encephalopathy.

Design: A qualitative study involving 25 semistructured interviews with parents or other family members (caregivers) of infants who were diagnosed with, and treated for, neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia.

Setting: Interviews were conducted in high-income countries (HiCs) (n=11) by Zoom video conferencing software and in LMiCs (n=14) by phone or face to face.

Platelet response to aspirin in UK and Irish pregnancy cohorts: a genome-wide approach.

A multi-center prospective cross-sectional and genome-wide association study (GWAS) recruited pregnant women taking low dose aspirin. Objectives were to (i) develop pregnancy-specific 95% reference intervals for a range of laboratory based platelet function tests (PFTs); (ii) select an optimal and acceptable PFT that reflected aspirin's COX-1 inhibition in women with confirmed aspirin adherence in pregnancy; and (iii) identify genomic variants that may influence pregnant women's platelet response to aspirin.The study included two independent cohorts of pregnant women.

Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial.

Background: The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants' survey responses in between rounds. By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process.

COHESION: core outcomes in neonatal encephalopathy (protocol).

Background: Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy.

Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis.

Background: Postpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more after birth, is the leading cause of maternal death worldwide. The World Health Organization (WHO) recommends that all women giving birth should receive a prophylactic uterotonic agent. Despite the routine administration of a uterotonic agent for prevention, PPH remains a common complication causing one-quarter of all maternal deaths globally.

Updated guidance for the management of twin and triplet pregnancies from the National Institute for Health and Care Excellence guidance, UK: What's new that may improve perinatal outcomes?

In September 2019, NICE published updated guidance on the management of multiple pregnancy (NG 137). Many of the previous recommendations for care are upheld but there have been important changes: increased frequency of combined ultrasound/specialist antenatal care appointments for pregnancies containing a monochorionic placenta (twins and triplets), increased frequency of ultrasound monitoring in all triplet pregnancies, changes in the definition of selective growth restriction and its subsequent referral pathways, the introduction of some monitoring for twin (or triplet) anemia polycythemia sequence in monochorionic pregnancies (albeit in complex pregnancies or at an advanced stage), and a recommended timing of birth for any pregnancy with monoamniotic fetuses. New recommendations have been made for mode of delivery, fetal monitoring in labor, maternal analgesia, and the prevention of postpartum hemorrhage.

Antiplatelet agents for preventing pre-eclampsia and its complications.

Background: Pre-eclampsia is associated with deficient intravascular production of prostacyclin, a vasodilator, and excessive production of thromboxane, a vasoconstrictor and stimulant of platelet aggregation. These observations led to the hypotheses that antiplatelet agents, low-dose aspirin in particular, might prevent or delay development of pre-eclampsia.

Objectives: To assess the effectiveness and safety of antiplatelet agents, such as aspirin and dipyridamole, when given to women at risk of developing pre-eclampsia.

Early-onset twin-twin transfusion syndrome: Case series and systematic review.

Introduction: Data on the outcomes of early-onset twin-twin transfusion syndrome (TTTS), diagnosed before 18 weeks gestational age (GA), are sparse. We aimed to review the diagnosis, management and outcomes of early-onset TTTS.

Material And Methods: Pregnancy records at a single referral unit 2010-6 were reviewed.

How should we diagnose and assess the severity of PPH in clinical trials?

Interventions for prevention and treatment of postpartum haemorrhage have been the subject of numerous clinical trials. However, there is substantial heterogeneity in the outcomes reported by trialists, making the evidence difficult to interpret and compare across studies. Recommendations for clinical practice can be robust only if they are based on good-quality evidence, where therapeutic options are compared using indicators that are standardised, important and meaningful measures of wellbeing.

Antiplatelet therapy before or after 16 weeks' gestation for preventing preeclampsia: an individual participant data meta-analysis.

Background: The optimum time for commencing antiplatelet therapy for the prevention of preeclampsia and its complications is unclear. Aggregate data meta-analyses suggest that aspirin is more effective if given prior to 16 weeks' gestation, but data are limited because of an inability to place women in the correct gestational age subgroup from relevant trials.

Objective: The objective of the study was to use the large existing individual participant data set from the Perinatal Antiplatelet Review of International Studies Collaboration to assess whether the treatment effects of antiplatelet agents on preeclampsia and its complications vary based on whether treatment is started before or after 16 weeks' gestation.

A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.

Objective: To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women.

Methods: A two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were used to develop a consensus on a set of critical and important outcomes. We approached five stakeholder groups (parents, midwives, obstetricians, neonatologists, and researchers) from middle- and high-income countries.

Pathway analysis of genetic factors associated with spontaneous preterm birth and pre-labor preterm rupture of membranes.

Background: Pre-term birth (PTB) remains the leading cause of infant mortality and morbidity. Its etiology is multifactorial, with a strong genetic component. Genetic predisposition for the two subtypes, spontaneous PTB with intact membranes (sPTB) and preterm prelabor rapture of membranes (PPROM), and differences between them, have not yet been systematically summarised.

Renal stones in pregnancy.

Diagnosis and treatment of renal stones during pregnancy is a complex problem. Risks to the fetus from ionising radiation and interventional procedures need to be balanced with optimising clinical care for the mother. Management of such patients requires a clear understanding of available options, with a multidisciplinary team approach.

Drugs for treatment of very high blood pressure during pregnancy.

Background: Very high blood pressure during pregnancy poses a serious threat to women and their babies. The aim of antihypertensive therapy is to lower blood pressure quickly but safety, to avoid complications. Antihypertensive drugs lower blood pressure but their comparative effectiveness and safety, and impact on other substantive outcomes is uncertain.

Referral patterns for pelvic floor disorders.

Introduction And Hypothesis: To determine referral patterns to the gynecology directorate for symptomatic pelvic organ prolapse and urinary incontinence

Methods: A prospective multicenter survey of three district general hospitals in Northwest England. Referral letters sent by family physicians to consultants were studied over a three-month period. Main outcome measures were presenting complaints of prolapse and incontinence

Results: Two thousand seven hundred sixty-nine referral letters were surveyed.