Strategies for optimising early detection and obstetric first response management of postpartum haemorrhage at caesarean birth: a modified Delphi-based international expert consensus.

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.

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. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle. RESULTS: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28). CONCLUSIONS: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery. (Funded by the Bill and Melinda Gates Foundation; E-MOTIVE ClinicalTrials.gov number, NCT04341662.).

Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. When PPH occurs, early identification of bleeding and prompt management using evidence-based guidelines, can avert most PPH-related severe morbidities and deaths. However, adherence to the World Health Organization recommended practices remains a critical challenge. A potential solution to inefficient and inconsistent implementation of evidence-based practices is the application of a 'clinical care bundle' for PPH management. A clinical care bundle is a set of discrete, evidence-based interventions, administered concurrently, or in rapid succession, to every eligible person, along with teamwork, communication, and cooperation. Once triggered, all bundle components must be delivered. The E-MOTIVE project aims to improve the detection and first response management of PPH through the implementation of the "E-MOTIVE" bundle, which consists of (1) Early PPH detection using a calibrated drape, (2) uterine Massage, (3) Oxytocic drugs, (4) Tranexamic acid, (5) Intra Venous fluids, and (6) genital tract Examination and escalation when necessary. The objective of this paper is to describe the protocol for the formative phase of the E-MOTIVE project, which aims to design an implementation strategy to support the uptake of this bundle into practice. METHODS: We will use behavior change and implementation science frameworks [e.g. capability, opportunity, motivation and behavior (COM-B) and theoretical domains framework (TDF)] to guide data collection and analysis, in Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania. There are four methodological components: qualitative interviews; surveys; systematic reviews; and design workshops. We will triangulate findings across data sources, participant groups, and countries to explore factors influencing current PPH detection and management, and potentially influencing E-MOTIVE bundle implementation. We will use these findings to develop potential strategies to improve implementation, which will be discussed and agreed with key stakeholders from each country in intervention design workshops. DISCUSSION: This formative protocol outlines our strategy for the systematic development of the E-MOTIVE implementation strategy. This focus on implementation considers what it would take to support roll-out and implementation of the E-MOTIVE bundle. Our approach therefore aims to maximize internal validity in the trial alongside future scalability, and implementation of the E-MOTIVE bundle in routine practice, if proven to be effective. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04341662.

Excessive bleeding after birth is the leading cause of maternal death globally. The World Health Organization (WHO) has recommended several treatment options for bleeding after birth. However, these treatments are not used regularly, or consistently for all women. A key underlying issue is that it is challenging for health workers to identify when women are bleeding too much, because measuring the amount of blood loss is difficult.Maternal health experts have proposed a new clinical 'care bundle' for caring for women with excessive bleeding after birth. A care bundle is a way to group together multiple treatments (e.g. 3­5 treatments). These treatments are then given to the woman at the same time, or one after another in quick succession, and supported by strategies to improve teamwork, communication, and cooperation.This is a research protocol for the preliminary phase of our study ("E-MOTIVE"), which means that it is a description of what we plan to do and how we plan to do it. The aim of our study is to develop a strategy for how we will test whether the E-MOTIVE bundle works through collaborative activities with midwives and doctors in five countries (Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania) to develop a strategy for how we will test whether the E-MOTIVE bundle works. We plan to do this by conducting interviews and surveys with midwives and doctors, and reviewing other research conducted on PPH to understand what works in different settings. We will discuss our research findings in a workshop, with midwives and doctors in the study countries to co-create a strategy that will work for them, based on their needs and preferences.

Using Helping Mothers Survive to Improve Intrapartum Care.

Data from the past decade have revealed that neonatal mortality represents a growing burden of the under-5 mortality rate. To further reduce these deaths, the focus must expand to include building capacity of the workforce to provide high-quality obstetric and intrapartum care. Obstetric complications, such as hypertensive disorders and obstructed labor, are significant contributors to neonatal morbidity and mortality. A well-prepared workforce with the necessary knowledge, skills, attitudes, and motivation is required to rapidly detect and manage these complications to save both maternal and newborn lives. Traditional off-site, didactic, and lengthy training approaches have not always yielded the desired results. Helping Mothers Survive training was modeled after Helping Babies Breathe and incorporates further evidence-based methodology to deliver training on-site to the entire team of providers, who continue to practice after training with their peers. Research has revealed that significant gains in health outcomes can be reached by using this approach. In the coronavirus disease 2019 era, we must look to translate the best practices of these training programs into a flexible and sustainable model that can be delivered remotely to maintain quality services to women and their newborns.

"Practice so that the skill does not disappear": mixed methods evaluation of simulator-based learning for midwives in Uganda.

BACKGROUND: Postpartum hemorrhage and neonatal asphyxia are leading causes of maternal and neonatal mortality, respectively, that occur relatively rarely in low-volume health facilities in sub-Saharan Africa. Rare occurrence of cases may limit the readiness and skills that individual birth attendants have to address complications. Evidence suggests that simulator-based training and practice sessions can help birth attendants maintain these life-saving skills; one approach is called "low-dose, high-frequency" (LDHF). The objective of this evaluation is to determine the facilitating factors and barriers to participation in LDHF practice, using qualitative and quantitative information. METHODS: A trial in 125 facilities in Uganda compared three strategies of support for LDHF practice to improve retention of skills in prevention and treatment of postpartum hemorrhage and neonatal asphyxia. Birth attendants kept written logs of their simulator-based practice sessions, which were entered into a database, then analyzed using Stata to compare frequency of practice by the study arm. The evaluation also included 29 in-depth interviews and 19 focus group discussions with birth attendants and district trainers. Transcripts were entered in Atlas.ti software for coding, then analyzed using content analysis to identify factors that motivated or discouraged simulator-based practice. RESULTS: Practice log data indicated that simulator-based practice sessions occurred more frequently in facilities where one or two practice coordinators helped schedule and lead the practice sessions and in health centers compared to hospitals. The qualitative data suggest that birth attendants who practiced more were motivated by a desire to maintain skills and be prepared for emergencies, external recognition, and establishing a set schedule. Barriers to consistent practice included low staffing levels, heavy workloads, and a sense that competency can be maintained through routine clinical care alone. Some facilities described norms around continuing education and some did not. CONCLUSIONS: Designating practice coordinators to lead their peers in simulator-based practice led to more consistent skills practice within frontline health facilities. Ongoing support, scheduling of practice sessions, and assessment and communication of motivation factors may help sustain LDHF practice and similar forms of continuing professional development. TRIAL REGISTRATION: Registered with clinicaltrials.gov #NCT03254628 on August 18, 2018 (registered retrospectively).

Peer-assisted learning after onsite, low-dose, high-frequency training and practice on simulators to prevent and treat postpartum hemorrhage and neonatal asphyxia: A pragmatic trial in 12 districts in Uganda.

An urgent need exists to improve and maintain intrapartum skills of providers in sub-Saharan Africa. Peer-assisted learning may address this need, but few rigorous evaluations have been conducted in real-world settings. A pragmatic, cluster-randomized trial in 12 Ugandan districts provided facility-based, team training for prevention and management of postpartum hemorrhage and birth asphyxia at 125 facilities. Three approaches to facilitating simulation-based, peer assisted learning were compared. The primary outcome was the proportion of births with uterotonic given within one minute of birth. Outcomes were evaluated using observation of birth and supplemented by skills assessments and service delivery data. Individual and composite variables were compared across groups, using generalized linear models. Overall, 107, 195, and 199 providers were observed at three time points during 1,716 births across 44 facilities. Uterotonic coverage within one minute increased from: full group: 8% (CI 4%‒12%) to 50% (CI 42%‒59%); partial group: 19% (CI 9%‒30%) to 42% (CI 31%‒53%); and control group: 11% (5%‒7%) to 51% (40%‒61%). Observed care of mother and newborn improved in all groups. Simulated skills maintenance for postpartum hemorrhage prophylaxis remained high across groups 7 to 8 months after the intervention. Simulated skills for newborn bag-and-mask ventilation remained high only in the full group. For all groups combined, incidence of postpartum hemorrhage and retained placenta declined 17% and 47%, respectively, from during the intervention period compared to the 6‒9 month period after the intervention. Fresh stillbirths and newborn deaths before discharge decreased by 34% and 62%, respectively, from baseline to after completion, and remained reduced 6‒9 months post-implementation. Significant improvements in uterotonic coverage remained across groups 6 months after the intervention. Findings suggest that while short, simulation-based training at the facility improves care and is feasible, more complex clinical skills used infrequently such as newborn resuscitation may require more practice to maintain skills. Trial Registration: ClinicalTrials.gov NCT03254628.

Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based training approaches on day of birth care among maternal and newborn healthcare providers in Ebonyi and Kogi States, Nigeria; a randomized controlled trial.

BACKGROUND: There is limited information from low and middle-income countries on learning outcomes, provider satisfaction and cost-effectiveness on the day of birth care among maternal and newborn health workers trained using onsite simulation-based low-dose high frequency (LDHF) plus mentoring approach compared to the commonly employed offsite traditional group-based training (TRAD). The LDHF approach uses in-service learning updates to deliver information based on local needs during short, structured, onsite, interactive learning activities that involve the entire team and are spaced over time to optimize learning. The aim of this study will be to compare the effectiveness and cost of LDHF versus TRAD approaches in improving knowledge and skill in maternal and newborn care and to determine trainees' satisfaction with the approaches in Ebonyi and Kogi states, Nigeria. METHODS: This will be a prospective cluster randomized control trial. Sixty health facilities will be randomly assigned for day of birth care health providers training through either LDHF plus mobile mentoring (intervention arm) or TRAD (control arm). There will be 150 trainees in each arm. Multiple choices questionnaires (MCQs), objective structured clinical examinations (OSCEs), cost and satisfaction surveys will be administered before and after the trainings. Quantitative data collection will be done at months 0 (baseline), 3 and 12. Qualitative data will also be collected at 12-month from the LDHF arm only. Descriptive and inferential statistics will be used as appropriate. Composite scores will be computed for selected variables to determine areas where service providers have good skills as against areas where their skills are poor and to compare skills and knowledge outcomes between the two groups at 0.05 level of statistical significance. DISCUSSION: There is some evidence that LDHF, simulation and practice-based training approach plus mobile mentoring results in improved skills and health outcomes and is cost-effective. By comparing intervention and control arms the authors hope to replicate similar results, evaluate the approach in Nigeria and provide evidence to Ministry of Health on how and which training approach, frequency and setting will result in the greatest return on investment. TRIAL REGISTRATION: The trial was retrospectively registered on 24th August, 2017 at ClinicalTrials.Gov: NCT03269240 .

Successful implementation of Helping Babies Survive and Helping Mothers Survive programs-An Utstein formula for newborn and maternal survival.

Globally, the burden of deaths and illness is still unacceptably high at the day of birth. Annually, approximately 300.000 women die related to childbirth, 2.7 million babies die within their first month of life, and 2.6 million babies are stillborn. Many of these fatalities could be avoided by basic, but prompt care, if birth attendants around the world had the necessary skills and competencies to manage life-threatening complications around the time of birth. Thus, the innovative Helping Babies Survive (HBS) and Helping Mothers Survive (HMS) programs emerged to meet the need for more practical, low-cost, and low-tech simulation-based training. This paper provides users of HBS and HMS programs a 10-point list of key implementation steps to create sustained impact, leading to increased survival of mothers and babies. The list evolved through an Utstein consensus process, involving a broad spectrum of international experts within the field, and can be used as a means to guide processes in low-resourced countries. Successful implementation of HBS and HMS training programs require country-led commitment, readiness, and follow-up to create local accountability and ownership. Each country has to identify its own gaps and define realistic service delivery standards and patient outcome goals depending on available financial resources for dissemination and sustainment.

Using direct clinical observation to assess the quality of cesarean delivery in Afghanistan: an exploratory study.

BACKGROUND: As part of a National Emergency Obstetric and Newborn Care (EmONC) Needs Assessment, a special study was undertaken in July 2010 to examine the quality of cesarean deliveries in Afghanistan and examine the utility of direct clinical observation as an assessment method in low-resource settings. METHODS: This cross-sectional assessment of the quality of cesareans at 14 facilities in Afghanistan included a survey of surgeons regarding their routine cesarean practices, direct observation of 29 cesarean deliveries and comparison of observations with facility records for 34 additional cesareans conducted during the 3 days prior to the observation period at each facility. For both observed cases and record reviews, we assessed time intervals between specified points of care-arrival to the ward, first evaluation, detection of a complication, decision for cesarean, incision, and birth. RESULTS: All time intervals with the exception of "decision to skin incision" were longer in the record reviews than in observed cases. Prior cesarean was the most common primary indication for all cases. All mothers in both groups observed survived through one hour postpartum. Among newborns there were two stillbirths (7%) in observed births and seven (21%) record reviews. Although our sample is too small to show statistical significance, the difference is noteworthy. In six of the reviewed cesareans resulting in stillbirth, a fetal heart rate was recorded in the operating theater, although four were recorded as macerated. For the two fresh stillbirths, the cesarean surgeries were recorded as scheduled and not urgent. CONCLUSIONS: Direct observation of cesarean deliveries enabled us to assess a number of preoperative, postoperative, and intraoperative procedures that are often not described in medical records in low resource settings. Comparison of observations with findings from provider interviews and facility records allowed us to infer whether observed practices were typical of providers and facilities and detect potential Hawthorne effects.

Competency-based training "Helping Mothers Survive: Bleeding after Birth" for providers from central and remote facilities in three countries.

OBJECTIVE: To validate a new training module for skilled and semiskilled birth attendants authorized to provide care at birth-Helping Mothers Survive: Bleeding After Birth (HMS:BAB)-aimed at reducing postpartum hemorrhage, the leading cause of maternal mortality worldwide. BAB training involves single-day, facility-based training that emphasizes simulation of scenarios related to prevention, detection, and management of postpartum hemorrhage. METHODS: A total of 155 skilled and semiskilled birth attendants participated in training in India, Malawi, and Zanzibar, Tanzania. Knowledge and confidence were assessed before and after training. Skills and acceptability were assessed after training. RESULTS: Knowledge and confidence scores improved significantly from pre- to post-training among all cadres in all three countries. The proportion of providers with passing knowledge scores increased significantly from pre- to post-training among all cadres except for those already high at baseline. On three post-training skills tests the overall proportion of individuals with a passing score ranged from 83% to 89%. CONCLUSION: BAB training in prevention and management of postpartum hemorrhage increased knowledge and confidence among skilled and semiskilled birth attendants. Further studies are needed to determine the impact of this training on skills retention and clinical outcomes following postpartum hemorrhage, after broader implementation of the training program.

Patterns in training, knowledge, and performance of skilled birth attendants providing emergency obstetric and newborn care in Afghanistan.

OBJECTIVE: To assess current skilled birth attendants (SBAs) in Afghanistan, looking for opportunities to improve quality and expand emergency obstetric and newborn care (EmONC) services. METHODS: The EmONC training, knowledge, and skills of 82 doctors and 142 midwives in 78 facilities were assessed using interviews, knowledge tests, observation of performance on anatomic models, and decision-making scenarios. RESULTS: Three-quarters had training in at least half of the 24 possible skills. Doctors' and midwives' levels of training in specific skills were generally similar. Doctors were more likely to be very confident of their skills. Midwives and doctors scored similarly in assessments of decision making and performance of technical skills. SBAs showed weaknesses in specific steps to manage common high-risk emergencies. Decision-making skills were good in a maternal care scenario but weak on managing a newborn not breathing. Doctors' and midwives' scores were similar. CONCLUSION: Midwives and doctors in Afghanistan are similarly competent. Focusing on training and deploying midwives may be cost effective without diminishing quality. In-service training and job rotation could help SBAs retain their EmONC skills. Training and practice to manage common high-risk emergencies deserve priority.

Quality of caesarean delivery services and documentation in first-line referral facilities in Afghanistan: a chart review.

BACKGROUND: Increasing appropriate use and documentation of caesarean section (CS) has the potential to decrease maternal and perinatal mortality in settings with low CS rates. We analyzed data collected as part of a comprehensive needs assessment of emergency obstetric and newborn care (EmONC) facilities in Afghanistan to gain a greater understanding of the clinical indications, timeliness, and outcomes of CS deliveries. METHODS: Records were reviewed at 78 government health facilities expected to function as EmONC providers that were located in secure areas of the country. Information was collected on the three most recent CS deliveries in the preceding 12 months at facilities with at least one CS delivery in the preceding three months. After excluding 16 facilities with no recent CS deliveries, the sample includes 173 CS deliveries at 62 facilities. RESULTS: No CS deliveries were performed in the previous three months at 21% of facilities surveyed; all of these were lower-level facilities. Most CS deliveries (88%) were classified as emergencies, and only 12% were referrals from another facility. General anesthesia was used in 62% of cases, and spinal or epidural anesthesia in 34%. Only 28% of cases were managed with a partograph. Surgery began less than one hour after the decision for a CS delivery in just 30% of emergency cases. Among the 173 cases, 27 maternal deaths, 28 stillbirths, and 3 early neonatal deaths were documented. In cases of maternal and fetal death, the most common indications for CS delivery were placenta praevia or abruption and malpresentation. In 62% of maternal deaths, the fetus was stillborn or died shortly after birth. In 48% of stillbirths, the fetus had a normal heart rate at the last check. Information on partograph use was missing in 38% of cases, information on parity missing in 23% of cases and indications for cesareans missing in 9%. CONCLUSIONS: Timely referral within and to EmONC facilities would decrease the proportion of CS deliveries that develop to emergency status. While the substantial mortality associated with CS in Afghanistan may be partly due to women coming late for obstetric care, efforts to increase the availability and utilization of CS must also focus on improving the quality of care to reduce mortality. Key goals should be encouraging use of partographs and improving decision-making and documentation around CS deliveries.

Where there is no obstetrician--increasing capacity for emergency obstetric care in rural India: an evaluation of a pilot program to train general doctors.

BACKGROUND: Maternal mortality continues to be high in rural India. Chief among the reasons for this is a severe shortage of obstetricians to perform cesarean delivery and other skills required for emergency obstetric care (EmOC). In 2006, the Government of India and the Federation of Obstetric and Gynecological Societies of India (FOGSI) with technical assistance from Jhpiego, instituted a nationwide, 16-week comprehensive EmOC (CEmOC) training program for general medical officers (MOs). This program is based on an earlier pilot project (2004-2006). OBJECTIVE: To evaluate the pilot project, and identify lessons learned to inform the nationwide scale-up. METHODS: The lead author (CE) visited trainees and their facilities to evaluate the project. Eight data collection tools were created, which included interviews with informants (program/government staff, regional/international experts, trainees and trainers), facility observation, and facility-based data collection of births and maternal/newborn deaths during the study period. RESULTS: More trainees performed each of the basic EmOC skills after the training than before. After training, 10 of 15 facilities to which trainees returned could provide all signal functions for basic EmOC whereas only 2 could do so before. For comprehensive EmOC, 2 facilities with obstetricians were providing all functions before and 2 were doing so after, even though the specialists had left those facilities and services were being provided by CEmOC trainees. Barriers to providing, or continuing to provide, EmOC for some trainees included insufficient training for cesarean delivery, lack of anesthetists, equipment and infrastructure (operating theater, blood services, forceps/vacuum, manual vacuum aspiration syringes). CONCLUSION: Although MOs can be trained to provide CEmOC (including cesarean delivery), without proper selection of facilities and trainees, adequate training, and support, this strategy will not substantially improve the availability of comprehensive EmOC in India. RECOMMENDATIONS: To implement a successful nationwide scale-up, several steps should be taken. These include, selecting motivated trainees, implementing the training as it was designed, improving support for trainees, and ensuring appropriate staff and infrastructure for trainees at their facilities before they return from training.