BACKGROUND:Poor access to water, sanitation and hygiene exacerbates the spread of infections among newborns. The BabyGel cluster randomised trial assessed the effectiveness of a community-level alcohol-based hand rub with a training component in reducing infection or death rates among newborns in Uganda. OBJECTIVE:Nested in the BabyGel trial, this study investigated the acceptability of the BabyGel intervention among mothers and household members in Eastern Uganda, using the Theoretical Framework of Acceptability. METHODS:In 2022, we conducted individual semistructured interviews with mothers, and group interviews with mothers and other household members, all recruited from intervention-arm clusters. Thematic analysis combined inductive and deductive coding, structured by the framework's seven constructs: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy. RESULTS:Twenty mothers and 14 household members participated in 10 individual and 10 small group interviews. Participants found the intervention generally acceptable, appreciating its convenience and perceived protection against infection. Many described hand hygiene changes that persisted beyond the intervention period. However, concerns related to its harmful effects, spiritual beliefs and social tensions with visitors occasionally influenced its use. CONCLUSION:Alcohol-based hand rub combined with a training component was generally well accepted, driven by perceived health and practical benefits, although concerns related to safety, belief systems and social dynamics remained. Because data collection coincided with the COVID-19 pandemic, a period of heightened hygiene awareness, the acceptability observed could differ in nonpandemic periods. Culturally adapted education, community engagement and reinforcement of correct use may enhance acceptability and sustainability in similar settings.
Background Disrespectful maternity care, which remains prevalent primarily in low- and middle-income countries, has a detrimental effect on women's childbirth experiences and deters them from seeking care at health facilities. Yet interventions to reduce it are limited, and focus less on the newborn. We conducted a study to co-develop with key stakeholders a maternal and newborn respectful care bundle (a group of evidence -based interventions) to reduce disrespectful care in Malawi and Tanzania. Methods A mixed-methods study guided by an Appreciative Inquiry approach and Behaviour Change Wheel was conducted during the pre-implementation phase of a larger intervention development and evaluation study. The intervention development process comprised three stages: formative research, intervention co-designing, and intervention refinement to ensure contextual relevance and acceptability. Methods included interviews with women, community surveys, focus group discussions with healthcare workers, and a Nominal Group Technique to achieve consensus, observations and interviews during optimisation. Community Engagement and Involvement group of women representatives ensured women’s perspectives throughout. Results This process resulted into the identification of an intervention bundle which has five components: 1. Valuing staff, 2. Training and mentorship 3. Privacy and confidentiality 4. Supportive leadership and 5. Community engagement and involvement. Behaviour change techniques and Respectful Care Champions were incorporated within the intervention strategies. Conclusion The resulting Respectful Maternal and Newborn Care bundle identified through a multi-stage process is an evidence-based, multi-component intervention with potential to reduce disrespectful care. Its participatory development supports cultural acceptability. Findings from its implementation and evaluation will be reported elsewhere.
Background Approximately 5% of women will be affected by fetal malposition at full cervical dilatation, with the occiput in transverse or posterior positions. These women are more likely to require assistance to give birth to their babies with either rotational vaginal birth or cesarean birth at full dilatation. Three different rotational methods can be used: rotational (Kielland) forceps, rotational vacuum, and manual rotation. Current evidence supporting the use of the 3 rotational methods is only from observational data. To date, no randomized controlled trial (RCT) of rotational methods has been completed. Objective This study aimed to evaluate whether manual rotation of the fetal head in persistent malposition at full cervical dilatation reduces the risk of severe maternal perineal trauma without substantially increasing the risk of cesarean birth, compared with instrumental rotation. Methods ROTATE is a pragmatic, multicenter, 2-arm parallel group, open-label RCT of manual versus instrumental rotation of the fetal head in malposition at birth with an internal pilot and an embedded qualitative process evaluation. The primary outcome is to evaluate whether manual versus instrumental rotation at full cervical dilatation reduces the risk of severe perineal trauma (superiority outcome), defined as a third- or fourth-degree tear, without substantially increasing the risk of cesarean birth at full dilatation (noninferiority coprimary outcome). A sample size calculation found that 4988 participants are required to detect a clinically meaningful reduction of third- or fourth-degree tears from 6% to 4% with 90% power (α=.05). A total sample size of 5200 participants from approximately 40 sites is anticipated, as loss to follow-up is expected to be about 4%. Neonatal trauma, a composite of potential outcomes relating to intrapartum hypoxia and physical trauma, is a safety signal. The setting is National Health Service consultant–led maternity units across the United Kingdom. Randomization is performed after eligibility has been confirmed and verbal consent has been obtained. Randomization is undertaken via a 24-hour telephone service or web-based system. Participants are randomized at an individual level on a 1:1 ratio to manual or instrumental (forceps or vacuum) rotation. Written consent is sought postnatally. Results Data collection took place between September 9, 2022, and November 5, 2024. The total number of recruits is 321. The data analysis of primary and secondary outcomes is ongoing at the time of submission. Conclusions A multicenter RCT of rotational methods has been conducted in the United Kingdom. Although the trial was closed early due to challenges in meeting recruitment targets, the results are still highly anticipated. Trial Registration ISRCTN ISRCTN10193017; https://www.isrctn.com/ISRCTN10193017 International Registered Report Identifier (IRRID) DERR1-10.2196/72505
Postpartum haemorrhage (PPH) is common, affecting an estimated 13% of women having vaginal birth and 31% of women having caesarean birth. Successful management of PPH requires early and accurate diagnosis and effective treatment. A systematic review found that subjective visual estimation of blood loss misses 52% of PPH diagnoses at vaginal birth (pooled sensitivity 48%, 95% CI 44-53), and probably more at caesarean birth. The WHO-International Federation of Gynecology and Obstetrics-International Confederation of Midwives consolidated guidelines on PPH therefore recommend objective quantification of blood loss with products such as a calibrated blood collection drape. When supported by a robust implementation strategy and a first-response treatment bundle, objective measurement of blood loss and monitoring of vital signs has been shown to diagnose PPH accurately and early, and improve clinical outcomes. Refractory PPH can progress to life-threatening PPH, which should be managed by a multidisciplinary team providing aggressive resuscitation and targeted treatment. Saving the life of a woman with excessive postpartum bleeding is a race against time. The six delays to avoid are: (1) in the diagnosis (by use of objective cumulative blood loss measurement and early trigger criteria), (2) in the first-response treatment (by authorising midwives to administer all components of a standardised bundle of interventions), (3) in the escalation (by use of explicit escalation criteria and red flags), (4) in the use of temporising measures (eg, non-pneumatic anti-shock garment), (5) in the identification and targeted management of any specific causes of bleeding, and (6) in the provision of blood and blood products. Quick actions to avoid these delays can mean the difference between life and death for a woman with PPH.
BACKGROUND:Maternal infection and sepsis are major causes of maternal death and severe illness worldwide, particularly in low- and middle-income countries. Inconsistent implementation of evidence-based recommendations for infection prevention and management and delays in detection and treatment of maternal sepsis contribute to the number of preventable deaths. METHODS:We conducted a cluster-randomized trial to assess a multicomponent intervention, the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program. This program was designed to support health care providers in achieving three goals: adherence to World Health Organization (WHO) hand-hygiene standards; adoption of evidence-based practices for maternal infection prevention and management; and early detection of sepsis and use of the FAST-M (fluids, antibiotics, source control, transfer if required, and monitoring) treatment bundle. Usual care was provided in the control group, along with dissemination of guidelines. The primary outcome was a composite of infection-related maternal death, infection-related near-miss event (events in which women survived a life-threatening complication), or severe infection-related illness (deep surgical-site, deep perineal, or body-cavity infection) among women who were pregnant or had recently been pregnant. RESULTS:We randomly assigned 59 health facilities (where 431,394 women gave birth during the trial) in Malawi and Uganda to the intervention group (30 clusters) or the usual-care group (29 clusters). A primary-outcome event occurred in 1.4% of the patients in the intervention group and in 1.9% of those in the usual-care group (risk ratio, 0.68; 95% confidence interval, 0.55 to 0.83; P<0.001). This effect was generally consistent between countries and among facilities of difference sizes and was sustained over time. CONCLUSIONS:Implementation of the APT-Sepsis program led to a significantly lower risk of a composite of infection-related maternal death, infection-related near-miss event, or severe infection-related illness than usual care. (Funded by the Joint Global Health Trials scheme and others; APT-Sepsis ISRCTN number, ISRCTN42347014.).
ABSTRACTKiller whales (Orcinus orca) have been documented to prey on white sharks (Carcharodon carcharias), in some cases causing localised shark displacement and triggering ecological cascades. Notably, a series of such predation events have been reported from South Africa over the last decade, with killer whales specifically targeting sharks' liver. However, observations of these interactions are rare, and knowledge of their frequency across the world's oceans remains limited. In October 2023, a 4.7 m (total length) white shark carcass washed ashore in southeastern Australia, coinciding with reports from citizen scientists of killer whales hunting a large, unidentified prey item in the area. Visual inspection of the carcass revealed that the liver, digestive, and reproductive organs were missing, and the presence of four distinctive bite wounds, one of which was characteristic of killer whale liver extraction as seen in South Africa. Genomic analyses performed on swabs taken from the bite wounds confirmed the presence of killer whale DNA in the major bite area, while the other bites were embedded with genetic material from the scavenging broadnose sevengill shark (Notorynchus cepedianus). These results provide confirmed evidence of killer whale predation on white sharks in Australia and the likely selective consumption of the liver, suggesting predations of this nature are more globally prevalent than currently assumed.
Induction of labor (IOL) is currently used for one in 10 pregnancies globally. Methods used for induction have shown major changes over time. Medical interventions trace their origins back to ancient civilizations, with evidence suggesting that they began over 5000 years ago in ancient Egypt. During this era, the Egyptians employed natural remedies such as castor oil and date fruits for the IOL. These early practices highlight the rich history and long-standing tradition of using natural substances in medical treatments, laying the foundation for the development of modern obstetric practices. After that, Hippocrates practiced mammary stimulation and mechanical cervical dilatation about 2500 years ago in Greece. Since then, there has been a marked change, especially over the last century, with the development of safer and more effective methods. Mechanical methods were the main method until the early 20th century, which were then substituted by pharmacological methods with more experiments in the mid to late 20th century. Nowadays, effectiveness, safety, cost, and client satisfaction are the main determinants of the methods used. This review summarizes how labor induction practices have evolved from the Egyptian era to the present-day randomized controlled trials and meta-analysis evidence, paying attention to their effectiveness, safety, and future directions.
Background Every year, 1.9 million stillbirths occur worldwide, of whom 1.5 million occur in sub-Saharan Africa (SSA) and Southeast Asia. Objectives This study aims to determine the incidence and risk factors and to describe underlying causes for term stillbirths in Eastern Uganda. Methods This was a cohort study of pregnant women enrolled at 34 weeks of gestation or more and followed to birth between January 2021 and January 2024. Enrolment and follow-up were done in the community by trained midwives. Using structured questionnaires, details of maternal health, pregnancy and birth were captured. Results We enrolled 6101 participants and analysed 5496 for incidence of term stillbirth and 5296 for risk factors. Of the participants, 4913/5296 (92.8%) were between 14 and 35 years, and 4456/5296 (84.1%) had a health facility birth. There were 101 term stillbirths (61 were intrapartum and 40 antepartum). The incidence of term stillbirth was 18.4 per 1000 births (95% CI 14.8 to 22.9). The most common underlying causes of stillbirth were prolonged or obstructed labour 32/101 (31.7%) and malaria 20/101 (19.8%). The factors associated with term stillbirths were caesarean birth (aRR 3.3; 95% CI 2.00 to 5.4), intimate partner violence (aRR 1.8; 95% CI 1.1 to 2.8) and maternal age above 35 years (aRR 2.2; 95% CI 1.2 to 3.9). Conclusion Eastern Uganda has a high rate of term stillbirths with more than half occurring during labour. Efforts are needed to improve the quality of birth care and to prevent intimate partner violence.
Introduction Excessive bleeding after childbirth (postpartum haemorrhage, PPH) affects 5% of births and causes 75 000 maternal deaths worldwide annually. It is the leading cause of direct maternal deaths globally and continues to be a major cause of mortality in the UK. Oxytocin is the standard first-line treatment for atonic PPH. The PPH rate is increasing, and this may be partially related to the overuse of oxytocics in labour. Laboratory studies on myometrium suggest that repeated use of oxytocics leads to the saturation of oxytocin receptors and reduced therapeutic efficacy of oxytocin. Carboprost (a prostaglandin analogue) is usually reserved for second-line management of atonic PPH. A systematic review comparing the efficacy of carboprost and conventional uterotonics for PPH prophylaxis found that carboprost was associated with less blood loss, but around 15% of women experienced side effects. The study’s aim is to compare intramuscular carboprost with intravenous oxytocin for the initial treatment of PPH. In addition, to assess the cost-effectiveness of both treatments, participants’ views on the two treatments and the consent process.Methods and analysis COPE is a double-blind, double-dummy, randomised controlled trial that aims to recruit 2000 women (1:1 allocation, stratified by mode of birth) across 20 hospitals in the UK. Due to the emergency nature of PPH, COPE uses a research without prior consent (RWPC) model. Randomisation and treatment will occur if eligibility criteria are met once bleeding starts. Postnatal consent will be sought for disclosure of identifiable data and continued follow-up. Clinical efficacy outcomes will be collected at 24 and 48 hours or at hospital discharge, if sooner. Questionnaires will also be collected at 24 hours and 4 weeks postrandomisation. Cost-effectiveness will be based on the incremental cost per quality-adjusted life-year, calculated from the perspective of the NHS and personal social services.Ethics and dissemination This study has been approved by the Coventry and Warwickshire Research Ethics Committee (REC) (18/WM/0227) and the Health Research Authority. Results will be disseminated via peer-reviewed publications.Trial registration number ISRCTN16416766.
BACKGROUND:Post-partum haemorrhage (PPH) is a common complication of labour. OBJECTIVE:To assess the effectiveness of oxytocin in comparison to no treatment for preventing PPH. SELECTION CRITERIA:Published and unpublished randomised controlled trials (RCTs) comparing systemic oxytocin to placebo or no intervention for preventing PPH were included. We did not apply language restrictions. SEARCH STRATEGY:We identified RCTs from the Cochrane network meta-analysis on uterotonics for preventing PPH and updated the search via: Ovid MEDLINE, Embase via Ovid, Web of Science, CENTRAL, CINAHL Plus and clinicaltrials.gov. DATA COLLECTION AND ANALYSIS:An Individual participant data (IPD) meta-analysis. MAIN RESULTS:Of 14 eligible RCTs, four provided IPD (n = 4304; 51.7% received oxytocin and 48.4% received placebo or no intervention). Meta-analysis of IPD showed that oxytocin decreased the risk of PPH ≥ 500 mL (aOR 0.59; 95% CI 0.46 to 0.74) and PPH ≥ 1000 mL (aOR 0.51; 95% CI 0.32 to 0.80). Of 10 RCTs that did not share data, seven met trustworthiness criteria while three did not. Trustworthy IPD and aggregate data (AD) from RCTs meeting trustworthiness criteria (n = 6003) showed that oxytocin significantly reduced the rate of PPH ≥ 500 mL (aOR 0.53; 95% CI 0.45 to 0.62) and PPH ≥ 1000 mL (aOR 0.59; 95% CI 0.48 to 0.71). RCTs not meeting trustworthiness criteria reported a larger risk reduction of oxytocin for PPH ≥ 500 mL (n = 1027; aOR 0.37; 95% CI 0.03 to 4.03) and PPH ≥ 1000 mL (n = 1157; aOR 0.13; 95% CI 0.01 to 1.45). CONCLUSIONS:Prophylactic oxytocin reduces the risk of PPH ≥ 500 mL and PPH ≥ 1000 mL compared to no treatment. Twenty-one percent of RCTs did not meet our pre-defined trustworthiness criteria, underlining the importance of integrity assessment in evidence synthesis.
Although induction of labour is becoming more common worldwide, there are few studies that assess women’s satisfaction with it. The newly developed Participant Generated Experience and Satisfaction (PaGES) Index collects brief qualitative data and quantifies it, allowing detailed satisfaction data to be collected on large populations. The PaGES data has never previously been compared to other methods of assessing study participants’ satisfaction. We aimed to triangulate PaGES Index, Likert questionnaire and interview data from a large, randomised trial of labour induction to fully understand women’s priorities, experience and satisfaction and to compare the findings of the three instruments. A convergent parallel multi-methods research design was used. Participants in the Misoprostol or Oxytocin for Labour Induction (MOLI) trial (n = 520) completed the PaGES Index before and after birth, listing priorities and allocating spending points to demonstrate their relative importance. Postpartum, participants scored their satisfaction with each item. Quantitative data was collected following birth on the acceptability of augmentation, delivery time, pain and anxiety using a Likert scale. Semi-structured interviews were also conducted, and thematic analysis was carried out using a framework approach. The data from 20 participants who had completed all three outcome measures were integrated and compared. Although common themes, such as pain, emerged from participants’ responses to the three instruments, each provided different insights. The Likert responses demonstrated overall satisfaction with the induction process but with high levels of pain and anxiety. Semi-structured interviews highlighted that safety and health of the baby was a key priority. The PaGES Index confirmed that the baby’s wellbeing was most important to women, but women also expressed a strong preference for vaginal delivery. The PaGES Index, Likert questionnaire and semi-structured interview data provide varied but complimentary insights on women’s birth experiences and their satisfaction with their induction process. The outputs of the three methods align, but the PaGES index was unique in capturing both detailed qualitative and quantitative information for all study participants. The MOLI study is registered in ClinicalTrials.gov (NCT03749902, Registration date: 21st Nov 2018) and Clinical Trial Registry, India (CTRI/2019/04/018827).
BACKGROUND:Hearing impairment and neurodevelopmental disorders pose a significant global health burden in children. The link between postnatal cytomegalovirus (CMV) infection and these outcomes remains unclear. This study explored the association of postnatal CMV infection with hearing and neurodevelopmental outcomes in term infants aged 3 to 10 months. METHODS:This was a cohort sub-study within the BabyGel cluster randomised trial in Eastern Uganda. From 1265 term infants screened for CMV, 219 were negative at birth but positive at 3 months, and were age-matched with 219 CMV-negative controls. CMV status was determined by PCR screening of saliva samples, with positive results confirmed using urine samples (Chai Open qPCR, Santa Clara, CA). From the established cohort, 424 infants were successfully followed up between 3 to 10 months of age. Clinical assessments included neurodevelopmental evaluation using the Malawi Developmental Assessment Tool, the Hammersmith Infant Neurological Examination, and hearing screening using Otoacoustic Emission testing (Otoport Lite, Otodynamics Limited). Statistical analyses were performed using descriptive statistics, chi-square tests and log binomial regression models with Stata 18. RESULTS:Of the 424 infants included in the study, 206 were postnatal CMV-infected and 218 were uninfected. Neurodevelopmental assessments indicated no differences between postnatal CMV-infected infants and uninfected groups (ARR 0.88, 95% CI [0.67, 1.15], p = 0.346). Hearing screening revealed a 1.99-fold increased risk of a positive result for postnatal CMV-infected infants compared to uninfected infants (67/106 vs. 39/106, 95% CI [1.27, 3.12], p = 0.003). CONCLUSION:Postnatal CMV infection was associated with more positive hearing screenings, though no significant differences in neurodevelopmental outcomes were observed in early infancy. Exploration into the feasibility of incorporating hearing and CMV screening into routine care will play a vital role in early identification and intervention, improving the management of both hearing and CMV-related conditions in resource-limited settings.
Introduction Caesarean use in India continues to rise and significant disparities exist. However, women and clinicians’ views are under-researched. This paper aims to explore women and clinicians’ views and preferences for mode of birth in two government hospitals in urban central India.Methods This qualitative study involved 53 semistructured interviews with high-risk women before and after induction of labour and eight focus groups with clinicians and researchers in two government hospitals in Maharashtra state. All women were recruited to the ‘Misoprostol or Oxytocin for Labour Induction’ (MOLI) randomised controlled trial (NCT03749902) and were induced for hypertensive disorders in pregnancy. Data were analysed using the framework approach to thematic analysis.Results Interactions between women, clinicians and families played an important role in women’s birth experiences. Most women strongly preferred vaginal birth. While a vaginal birth was important to women for their long-term health and well-being, the safety of the baby was the priority. Both women and clinicians justified caesarean use to promote fetal safety. Contrary to clinicians’ perceptions, women clearly understood their caesarean indications. The busy clinical environment was an important factor influencing the clinician’s decision and threshold for caesarean. Three themes arose from the data: (1) women’s preference for vaginal birth: a matter of ‘Trouble for two hours or trouble for two months’; (2) clinicians’ perspectives about caesarean use: ‘Don’t take a risk’; and (3) knowledge through experiences and interactions: ‘The pain didn’t come’.Conclusion Women strongly preferred ‘normal delivery’ but accepted caesarean birth to promote fetal safety. Clinicians felt labour and vaginal birth were often risky and prioritised fetal safety in this under-resourced context. Women who had a caesarean birth understood their indication for caesarean but, compared with vaginal birth, reported that caesarean caused them additional short- and long-term anxiety, health and social concerns.Trial registration number NCT04037683.
BackgroundOmphalitis is a bacterial infection of the umbilicus and/or surrounding tissues, occurring primarily in the neonatal period. Whereas it is known to be a major route of localized and often systemic infection, studies describing incidence and risk factors remain scanty, especially in resource limited settings where the condition is thought to be common. We assessed the incidence and risk factors for omphalitis among neonates born to women who received a birth kit containing chlorhexidine for umbilical cord care after birth in Eastern Uganda.Trial registration for the parent studyThe BabyGel trial was registered in the Pan African Clinical Trial Registry -(PACTR202004705649428 Registered 1 April 2020, https://pactr.samrc.ac.za/).MethodsWe conducted a community-based cohort study between January 2021 and June 2023. This study was nested within the BabyGel trial. Our outcome of interest was clinical omphalitis, defined as purulent discharge from the umbilical cord stump within the first twenty-eight days of life as witnessed by a study midwife. Data were analyzed using Stata version 17.0. Bivariable and multivariable analyses were conducted using Cox proportional hazard regression models to estimate hazard ratios (HR) of selected exposures and time to omphalitis.ResultsA total of 2052 neonates were enrolled; half of which were female (51.1%). The incidence of omphalitis was 3.0% (62/2052; 95% confidence interval (CI): 1.9%, 4.4%). The incidence rate of omphalitis was 1.6 cases per 1000 person days (95% CI: 1.1, 2.3). Neonates born at home were twice as likely to develop omphalitis as those born in a health facility (adjusted hazards ratio (AHR) 1.99; 95% CI: 1.01, 3.9).ConclusionThe incidence of omphalitis among neonates in Eastern Uganda was low. Home births carried twice the risk for omphalitis. Use of chlorhexidine coupled with close follow-up of neonates in the community by health workers and community health workers might have reduced the risk of omphalitis.
Every two minutes a woman dies from complications of pregnancy and childbirth. Most maternal deaths occur within the first 24 hours following birth, highlighting the importance of immediate postnatal care (iPNC). Self-care strategies are increasingly being employed to promote women-centred, continuous care provision. Despite international calls for development of strategies promoting self-care, none have been developed for self-monitoring in the immediate postnatal period. Fundamental to the development of a self-monitoring strategy, is an understanding of which signs and symptoms are predictive of maternal morbidity and mortality and can be easily assessed by mothers and birth companions, in health facilities, without the need for equipment. The objective of this study was to develop and achieve international consensus on the key signs and symptoms. A multi-step approach involving a systematic scoping review, two- round Delphi Survey, and expert consensus was employed to identify key signs and symptoms that can be self- assessed and predict morbidity and mortality in the immediate postnatal period. A comprehensive list of 351 key signs and symptoms was identified from 44 clinical practice guidelines. Subsequently, 134 signs and symptoms were reviewed by Delphi respondents and international expert consensus was achieved for 19 key signs and symptoms across seven condition categories. The signs that were considered both important and able to be self-assessed by mothers and birth companions in the first 24 hours following birth included change in consciousness, seizure, severe headache, persistent visual impairment, urinary incontinence, chest pain, shortness of breath, severe pallor, fast heartbeat, rejection of baby, suicidal/infanticidal, fever, heavy blood loss, soft flabby uterus, unable to urinate easily, foul smelling discharge, rigors, syncope/dizziness, abnormal coloured urine. This study identified key signs and symptoms which can be easily assessed by mothers and birth companions in the immediate postnatal period to identify those most at risk of morbidity and mortality. Further work is needed to validate this screening tool, and adapt it regionally and nationally.
Antenatal attendance is critical for pregnant women to receive the screening, health education and care plans that can optimise positive perinatal outcomes. In Tanzania, few women achieve the WHO-recommended 8 contacts with health workers, partly due to the limited screening and diagnosis services offered and health workers’ disrespectful attitudes. Mobile health solutions have potential to support the provision of comprehensive and respectful antenatal consultations, but these need to be rigorously assessed. The study aimed to adapt the Pregnancy and Newborn Diagnostic Assessment e-health system (PANDA), to incorporate respectful care prompts, and assess the feasibility of the new PANDA system to deliver prenatal care to women in rural Tanzania. A prospective, pre- and post-cohort mixed-methods study over 12 months was carried out in two primary facilities and one linked referral hospital. One hundred and sixty pregnant women (1st or 2nd trimester) were recruited; 80 received usual prenatal care and 80 received care through PANDA. Feasibility outcomes comprised recruitment and retention of women into the study, acceptability of the intervention and research processes, intervention fidelity, feasibility of data collection, confirmation of trial outcome measure and quality of implementation. Incorporation of respectful care prompts was achieved and considered acceptable. The study recruited to target (> 90
ObjectiveTo understand the experiences of women, birth partners and health professionals of verbal followed by retrospective written consent in a prospective cohort study of a device to manage postpartum haemorrhage (PPH).DesignGrounded Theory.SettingTertiary facility in North-West England, UK.SampleWe used purposive and theoretical sampling to recruit 51 participants; 12 women, 12 birth partners, 16 obstetricians and 11 midwives.MethodsSemi-structured interviews were conducted, using a topic guide for focus, until data saturation was achieved. Data were analysed using framework analysis technique.ResultsMost women wanted sufficient information to make a decision at the time of the event, rather than in advance, and preferred not to be overwhelmed with detail. A key factor in making the decision to participate was a positive and trusting relationship with the attending obstetrician. Obtaining consent for research in emergencies was viewed by obstetricians as requiring a different approach and more challenging than consent for standard procedures in an emergency.ConclusionsThis is one of the first studies to explore verbal followed by retrospective written consent processes with women, clinicians and observers. This was acceptable to all, however information needs to be appropriate, and those discussing consent require adequate training (199/200).
Objective There are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international expert’s consensus on evidence-based approaches for early detection and obstetric first response management of PPH intraoperatively and postoperatively in caesarean birth.Design Systematic review and three-stage modified Delphi expert consensus.Setting International.Population Panel of 22 global experts in PPH with diverse backgrounds, and gender, professional and geographic balance.Outcome measures Agreement or disagreement on strategies for early detection and first response management of PPH at caesarean birth.Results Experts agreed that the same PPH definition should apply to both vaginal and caesarean birth. For the intraoperative phase, the experts agreed that early detection should be accomplished via quantitative blood loss measurement, complemented by monitoring the woman’s haemodynamic status; and that first response should be triggered once the woman loses at least 500 mL of blood with continued bleeding or when she exhibits clinical signs of haemodynamic instability, whichever occurs first. For the first response, experts agreed on immediate administration of uterotonics and tranexamic acid, examination to determine aetiology and rapid initiation of cause-specific responses. In the postoperative phase, the experts agreed that caesarean birth-related PPH should be detected primarily via frequently monitoring the woman’s haemodynamic status and clinical signs and symptoms of internal bleeding, supplemented by cumulative blood loss assessment performed quantitatively or by visual estimation. Postoperative first response was determined to require an individualised approach.Conclusion These agreed on proposed approaches could help improve the detection of PPH in the intraoperative and postoperative phases of caesarean birth and the first response management of intraoperative PPH. Determining how best to implement these strategies is a critical next step.