UNASSIGNED: Infections and complications following cesarean delivery are a significant source of maternal mortality in Ethiopia.
UNASSIGNED: To study the effectiveness of a program to strengthen compliance with perioperative standards and reduce postoperative complications following cesarean delivery.
UNASSIGNED: This stepped-wedge cluster randomized clinical trial included patients undergoing cesarean delivery from August 24, 2021, to January 31, 2023, at 9 hospitals organized into 5 clusters in Ethiopia.
UNASSIGNED: Clean Cut, a multimodal surgical quality improvement program that includes process-mapping 6 perioperative standards and creating site-specific, systems-level improvements. The control period was the period before implementation of the intervention.
UNASSIGNED: The primary end point was surgical site infection rate, and secondary end points were maternal mortality and perinatal mortality and a composite outcome of infections and both mortality outcomes. All were assessed at 30 days postoperatively in the intervention and control groups, adjusting for clustering and demographics. Compliance with standards and the relationship between compliance and outcomes were also compared between the 2 arms.
UNASSIGNED: Among 9755 women undergoing cesarean delivery, 5099 deliveries (52.3%) occurred during the control period (2722 emergency cases [53.4%]) and 4656 (47.7%) during the intervention period (2346 emergency cases [50.4%]). Mean (SD) patient age was 27.04 (0.05) years. Thirty-day follow-up was completed for 5153 patients (52.8%). No significant reduction in infection rates was detected after the intervention (OR, 0.84; 95% CI, 0.55-1.27; P = .40). Intraoperative infection prevention standards improved significantly in the intervention arm vs control arm for compliance with at least 5 of the 6 standards (odds ratio [OR], 2.95; 95% CI, 2.40-3.62; P < .001). Regardless of trial arm, high compliance was associated with reduced odds of maternal (OR, 0.32; 95% CI, 0.11-0.93; P = .04) and perinatal (OR, 0.64; 95% CI, 0.47-0.89; P = .008) mortality.
UNASSIGNED: In this stepped-wedge cluster randomized clinical trial of patients undergoing cesarean delivery, no significant reductions in surgical site infections were observed. However, compliance with perioperative standards improved following the intervention.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04812522; Pan-African Clinical Trials Registry Identifier: PACTR202108717887402.

BACKGROUND: Racial inequities in severe maternal morbidity (SMM) and mortality constitute a public health crisis in the United States. Doula care, defined as care from birth workers who provide culturally appropriate, non-clinical support during pregnancy and postpartum, has been proposed as an intervention to help disrupt obstetric racism as a driver of adverse pregnancy outcomes in Black and other birthing persons of colour. Many state Medicaid programs are implementing doula programs to address the continued increase in SMM and mortality. Medicaid programs are poised to play a major role in addressing the needs of these populations with the goal of closing the racial gaps in SMM and mortality. This study will investigate the most effective ways that Medicaid programs can implement doula care to improve racial health equity.
METHODS: We describe the protocol for a mixed-methods study to understand how variation in implementation of doula programs in Medicaid may affect racial equity in pregnancy and postpartum health. Primary study outcomes include SMM, person-reported measures of respectful obstetric care, and receipt of evidence-based care for chronic conditions that are the primary causes of postpartum mortality (cardiovascular, mental health, and substance use conditions). Our research team includes doulas, university-based investigators, and Medicaid participants from six sites (Kentucky, Maryland, Michigan, Pennsylvania, South Carolina and Virginia) in the Medicaid Outcomes Distributed Research Network (MODRN). Study data will include policy analysis of doula program implementation, longitudinal data from a cohort of doulas, cross-sectional data from Medicaid beneficiaries, and Medicaid healthcare administrative data. Qualitative analysis will examine doula and beneficiary experiences with healthcare systems and Medicaid policies. Quantitative analyses (stratified by race groups) will use matching techniques to estimate the impact of using doula care on postpartum health outcomes, and will use time-series analyses to estimate the average treatment effect of doula programs on population postpartum health outcomes.
CONCLUSIONS: Findings will facilitate learning opportunities among Medicaid programs, doulas and Medicaid beneficiaries. Ultimately, we seek to understand the implementation and integration of doula care programs into Medicaid and how these processes may affect racial health equity. Study registration The study is registered with the Open Science Foundation ( https://doi.org/10.17605/OSF.IO/NXZUF ).

BACKGROUND: There has been debate over whether the existing World Health Organization (WHO) criteria accurately represent the severity of maternal near misses.
OBJECTIVE: This study assessed the diagnostic accuracy of two WHO clinical and laboratory organ dysfunction markers for determining the best cutoff values in a Latin American setting.
METHODS: A prospective multicenter cohort study was conducted in five Latin American countries. Patients with severe maternal complications were followed up from admission to discharge. Organ dysfunction was determined using clinical and laboratory data, and participants were classified according to severe maternal outcomes. This study compares the diagnostic criteria of Latin American Centre for Perinatology, Network for Adverse Maternal Outcomes (CLAP/NAMO) to WHO standards.
RESULTS: Of the 698 women studied, 15.2% had severe maternal outcomes. Most measured variables showed significant differences between individuals with and without severe outcomes (all P-values <0.05). Alternative cutoff values suggested by CLAP/NAMOs include pH ≤7.40, lactate ≥2.3 mmol/L, respiratory rate ≥ 24 bpm, oxygen saturation ≤ 96%, PaO2/FiO2 ≤ 342 mmHg, platelet count ≤189 × 109 × mm3, serum creatinine ≥0.8 mg/dL, and total bilirubin ≥0.67 mg/dL. No significant differences were found when comparing the diagnostic performance of the CLAP/NAMO criteria to that of the WHO standards.
CONCLUSIONS: The CLAP/NAMO values were comparable to the WHO maternal near-miss criteria, indicating that the WHO standards might not be superior in this population. These findings suggest that maternal near-miss thresholds can be adapted regionally, improving the identification and management of severe maternal complications in Latin America.

BACKGROUND: The maternal mortality and perinatal mortality rate in Cameroon are among the highest worldwide. To improve these outcomes, we conducted a formative qualitative assessment to inform the adaptation of a mobile provider-to-provider intervention in Cameroon. We explored the complex interplay of structural barriers on maternity care in this low-resourced nation. The study aimed to identify structural barriers to maternal care during the early adaptation of the mobile Medical Information Service via Telephone (mMIST) program in Cameroon.
METHODS: We conducted in-depth interviews and focus groups with 56 key stakeholders including previously and currently pregnant women, primary healthcare providers, administrators, and representatives of the Ministry of Health, recruited by purposive sampling. Thematic coding and analysis via modified grounded theory approach were conducted using NVivo12 software.
RESULTS: Three main structural barriers emerged: (1) civil unrest (conflict between Ambazonian militant groups and the Cameroonian government in the Northwest), (2) limitations of the healthcare system, (3) inadequate physical infrastructure. Civil unrest impacted personal security, transportation safety, and disrupted medical transport system. Limitations of healthcare system involved critical shortages of skilled personnel and medical equipment, low commitment to evidence-based care, poor reputation, ineffective health system communication, incentives affecting care, and inadequate data collection. Inadequate physical infrastructure included frequent power outages and geographic distribution of healthcare facilities leading to logistical challenges.
CONCLUSIONS: Dynamic inter-relations among structural level factors create barriers to maternity care in Cameroon. Implementation of policies and intervention programs addressing structural barriers are necessary to facilitate timely access and utilization of high-quality maternity care.

BACKGROUND: Obstetric hemorrhage remains a largely preventable cause of maternal mortality globally. The contribution of uterine atony to hemorrhage-related maternal mortality has decreased in France, while the contribution of other causes of obstetric hemorrhage such as surgical injury during cesarean has been reported to increase. However, little evidence exists regarding the risk factors and care processes of women who died from this cause of hemorrhage. Therefore, we aimed to describe the clinical profile, underlying mechanisms, and preventability factors among women who died from obstetric hemorrhage by surgical injury during cesarean section.
METHODS: Nationwide analysis of all hemorrhage-related maternal deaths by surgical injury during cesarean in France identified by the nationwide permanent enhanced maternal mortality surveillance system (ENCMM) between 2007 and 2018. We described the characteristics of the women, delivery hospitals, circumstances of hemorrhage, features of obstetric and resuscitation/transfusion care, and main preventability factors.
RESULTS: Between 2007 and 2018, hemorrhage-related maternal mortality in France decreased from 1.6/100 000 live births (95% CI 1.1-2.2) (39/2 472 650) in 2007-2009 to 0.8/100 000 live births (95% CI 0.5-1.3) (19/2 311 783) in 2016-2018. Hemorrhage-related maternal mortality ratio due to surgical injury during cesarean increased from 0.08 (95% CI 0.01-0.3) (2/2 472 650) to 0.2 (95% CI 0.07-0.5) (5/2 311 783) per 100 000 live births. Among the 18 women who died from surgical injury during cesarean over the 12-year study period, we report a high prevalence of obesity (67%, 12/18), previous cesarean (72%, 13/18), and second-stage cesareans (56%, 10/18). In 22% (4/18), cesarean section was performed in a hospital providing <1000 births annually, with no blood bank (39%, 7/18) or no adult intensive care (44%, 8/18) on-site. Overall preventability of deaths was 94% (17/18). Main preventability factors were related to delay in hemorrhage diagnosis (77%, 14/18) due to late recognition of abnormal parameters (33%, 6/18) and late bedside ultrasound (56%, 10/18), and delay in management due to insufficient surgical skills (56%, 10/18).
CONCLUSIONS: In France, surgical injury during cesarean section is an increasing, largely preventable contributor to hemorrhage-related maternal mortality, as other causes of fatal hemorrhage have become less frequent. The profile of these women showed a high prevalence of obesity, previous cesarean, second-stage cesarean, and delivery in hospitals with limited medical and surgical resources, which suggests explanatory mechanisms for the fatal outcome and opportunities for prevention.

BACKGROUND: Maternal and Perinatal Death Surveillance and Response (MPDSR) systems provide an opportunity for health systems to understand the determinants of maternal and perinatal deaths in order to improve quality of care and prevent future deaths from occurring. While there has been broad uptake and learning from low- and middle-income countries, little is known on how to effectively implement MPDSR within humanitarian contexts - where disruptions in health service delivery are common, infrastructural damage and insecurity impact the accessibility of care, and severe financial and human resource shortages limit the quality and capacity to provide services to the most vulnerable. This study aimed to understand how contextual factors influence facility-based MPDSR interventions within five humanitarian contexts.
METHODS: Descriptive case studies were conducted on the implementation of MPDSR in Cox\'s Bazar refugee camps in Bangladesh, refugee settlements in Uganda, South Sudan, Palestine, and Yemen. Desk reviews of case-specific MPDSR documentation and in-depth key informant interviews with 76 stakeholders supporting or directly implementing mortality surveillance interventions were conducted between December 2021 and July 2022. Interviews were recorded, transcribed, and analyzed using Dedoose software. Thematic content analysis was employed to understand the adoption, penetration, sustainability, and fidelity of MPDSR interventions and to facilitate cross-case synthesis of implementation complexities.
RESULTS: Implementation of MPDSR interventions in the five humanitarian settings varied in scope, scale, and approach. Adoption of the interventions and fidelity to established protocols were influenced by availability of financial and human resources, the implementation climate (leadership engagement, health administration and provider buy-in, and community involvement), and complex humanitarian-health system dynamics. Blame culture was pervasive in all contexts, with health providers often facing punishment or criminalization for negligence, threats, and violence. Across contexts, successful implementation was driven by integrating MPDSR within quality improvement efforts, improving community involvement, and adapting programming fit-for-context.
CONCLUSIONS: The unique contextual considerations of humanitarian settings call for a customized approach to implementing MPDSR that best serves the immediate needs of the crisis, aligns with stakeholder priorities, and supports health workers and humanitarian responders in providing care to the most vulnerable populations.

Little research has explored relationships between prenatal substance use policies and rates of maternal mortality across all 50 states, despite evidence that prenatal substance use elevates risk of maternal death. This study, utilizing publicly available data, revealed that state-level mandated testing laws predicted maternal mortality after controlling for population characteristics.

UNASSIGNED: In Brazil, postpartum hemorrhage (PPH) is a major cause of maternal morbidity and mortality. Data on the profile of women and risk factors associated with PPH are sparse. This study aimed to describe the profile and management of patients with PPH, and the association of risk factors for PPH with severe maternal outcomes (SMO).
UNASSIGNED: A cross-sectional study was conducted in Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) obstetric intensive care unit (ICU) between January 2012 and March 2020, including patients who gave birth at the hospital and that were admitted with PPH to the ICU.
UNASSIGNED: The study included 358 patients, of whom 245 (68.4%) delivered in the IMIP maternity, and 113 (31.6%) in other maternity. The mean age of the patients was 26.7 years, with up to eight years of education (46.1%) and a mean of six prenatal care. Uterine atony (72.9%) was the most common cause, 1.6% estimated blood loss, 2% calculated shock index (SI), 63.9% of patients received hemotransfusion, and 27% underwent hysterectomy. 136 cases of SMO were identified, 35.5% were classified as maternal near miss and 3.0% maternal deaths. Multiparity was associated with SMO as an antepartum risk factor (RR=1.83, 95% CI1.42-2.36). Regarding intrapartum risk factors, abruptio placentae abruption was associated with SMO (RR=2.2 95% CI1.75-2.81). Among those who had hypertension (49.6%) there was a lower risk of developing SMO.
UNASSIGNED: The principal factors associated with poor maternal outcome were being multiparous and placental abruption.

BACKGROUND: This update outlines amendments to the CHAMPION2/STRIPES2 cluster randomised trial protocol primarily made due to the COVID-19 pandemic and nationwide lockdown in India in 2020. These amendments were in line with national guidelines for health research during the COVID-19 pandemic.
METHODS: We did not change the original trial design, eligibility, and outcomes. Amendments were introduced to minimise the risk of COVID-19 transmission and ensure safety and wellbeing of trial staff, participants, and other villagers. CHAMPION2 intervention: participatory learning and action (PLA) and fixed day service (FDS) meeting were revised to incorporate social distancing and hygiene precautions. During the COVID-19 pandemic, PLA participation was limited to pregnant women and birthing partners. STRIPES2 intervention: before/after-school classes were halted for a period and then modified temporarily (reducing class sizes, and/or changing meeting places) with hygiene and safe distancing practices introduced.
METHODS: The research team gathered as much information as possible from participants by telephone. If the participant had no telephone or could not be contacted by telephone, data were collected in person. COVID-19 precautions: trial teams were trained on COVID-19 precautions and used personal protective equipment whilst in the villages for trial-related activities. After restarting the trial between June and September 2020 in a phased manner, some trial activities were suspended again in all the trial villages from April to June 2021 due to the second wave of COVID-19 cases and lockdown imposed in Satna, Madhya Pradesh. Trial timelines were also revised, with outcomes measured later than originally planned.
BACKGROUND: Clinical Trial Registry of India CTRI/2019/05/019296. Registered 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2 .

UNASSIGNED: Postpartum hemorrhage (PPH) is defined by the World Health Organization as blood loss of ≥500 mL within 24 h of delivery. Globally, hemorrhage accounts for 27.1% of maternal deaths, making it the leading direct cause of maternal death. PPH has been identified in more than two-thirds of reported hemorrhage-related deaths, causing 38% of maternal deaths in India. Tranexamic acid, an antifibrinolytic, has been used to control bleeding after PPH is identified.
UNASSIGNED: Antenatal women admitted for elective cesarean section were randomized into two arms: the case group (received one gram of tranexamic acid 20 min prior to skin incision) and the control group (received a placebo), each group consisting of 36 participants. Clinical Trials Registry - India (CTRI) registration number - CTRI/2021/02/031579.
UNASSIGNED: The mean (±standard deviation [SD]) intraoperative blood loss in the case group was 241.25 (±67.83) mL, and in the control group, it was 344.92 (±146.67) mL (P = 0.001), while postoperative blood loss did not differ significantly between the groups (P = 0.1470). In terms of the difference in hemoglobin, there was a significant difference between the two groups (P = 0.001). No significant maternal or neonatal side effects were found.
UNASSIGNED: Preoperative tranexamic acid, when given in elective cesarean section, significantly reduces intraoperative blood loss.