International Journal of MCH and AIDS最新文献

Maternal mortality remains one of the primary global health challenges of the 21st century, despite major medical advances in the field. Although solutions are available, inequities determine where mothers die, with the majority of maternal deaths occurring in low- and middle-income countries (LMICs). More than one-third of maternal deaths are related to obstetric hemorrhage and most commonly postpartum hemorrhage (PPH). Effective, quality-assured uterotonics significantly reduce PPH-related morbidity and mortality. Updated World Health Organization (WHO) recommendations on uterotonics used for PPH prevention include the addition of heat-stable carbetocin (HSC) to the suite of prophylactic uterotonic agents as well as the use of tranexamic acid (TXA) for PPH treatment. Both medicines are promising interventions in obstetric care. However, the introduction of these medicines faces numerous challenges to end-user access, such as decentralized procurement, time-consuming policy updates, market access barriers, lack of demand for quality-assured products, and inadequate systematic training and information provision, impeding access in many LMICs. Assessing the feasibility and acceptability of implementing these medicines in different resource settings can help bridge the gap between research and development to policy and practice, in an effort to reduce the significant health inequities facing women accessing the public health sector for quality care during labor and delivery. In this Special Collection, we explore the findings from mixed-methods implementation research studies in nine LMICs which support the acceptability and feasibility of HSC and TXA administration by healthcare providers, generating evidence to help inform the introduction and scale-up of these new and lesser-utilized PPH medicines.

Background and objective: The optimal use of oxytocin for preventing postpartum hemorrhage (PPH) faces challenges in many low-middle income countries (LMICs) owing to its storage and transportation prerequisites. We demonstrated Heat-Stable Carbetocin (HSC) for PPH prevention through an innovative Public-Private Partnership (PPP) model in 15 public health facilities of the Dewas District of Madhya Pradesh (MP) state in India. This study evaluates the feasibility and appropriate utilization of HSC in public health settings.

Methods: We analyzed facility-level data collected between August 2022 and July 2023 from selected 15 health facilities, where HSC was introduced. Prior to the introduction of HSC, all healthcare providers received training on Active Management of the Third Stage of Labor (AMTSL), use of HSC, and recording and reporting procedures. The supply of HSC in health facilities was ensured, and a robust mechanism was set up to monitor the progress.

Results: A total of 18,497 women were admitted for delivery in the 15 selected facilities. Uterotonic administration within one minute of delivery was almost universal (99.9%). No instance was recorded of using HSC either for induction of labor or management of PPH. In 636 cases (3.43%), HSC was not given for PPH prevention. Pearson's chi-square test was conducted to assess the relationship between HSC usage and the health facility's level. The HSC use was significantly higher in First Referral Unit (FRU) facilities compared to non-FRUs (p < 0.001). Moreover, the administration of HSC within one minute of delivery was also more prevalent in FRU facilities compared to non-FRUs (p < 0.001). The PPH incidence and case referral rates noted in this study were 0.7% and 16.7%, respectively, with no reported adverse drug events or deaths.

Conclusion and global health implications: Our study suggests the safe and appropriate use of HSC within India's public health system.

Background and objective: Maternal mortality, largely due to postpartum hemorrhage (PPH), remains high in resource-limited and crisis-affected settings, where heat-stable carbetocin (HSC) and tranexamic acid (TXA) offer promise for PPH prevention and treatment but lack evidence. This study, implemented in basic maternity facilities within humanitarian settings, explores healthcare providers' perspectives on an HSC and TXA-inclusive PPH intervention package and related operational challenges and facilitators.

Methods: Based on semi-structured interview guides and using thematic analysis, this qualitative research, through 13 focus group discussions and individual interviews, investigated the perspectives of 64 healthcare staff (mostly midwives) from eight basic emergency obstetric care facilities in South Sudanese and Ugandan settings hosting large numbers of forcibly displaced populations. The PPH intervention package comprised refresher training, an online provider community, PPH readiness kits, alarm bells, and displayed algorithms.

Results: Findings from both countries converged, highlighting providers' positive views on HSC and TXA. HSC effectiveness in preventing bleeding was acknowledged, bolstering staff's confidence in its use. TXA was perceived as effective although providers reported having less experience with it due to the limited number of PPH cases. Enabling factors included the ease of administration, practical training, endorsement by national and local authorities, and the absence of a cold chain requirement. Appreciation was given to the WhatsApp community of practice as it facilitated knowledge exchange, quality improvement projects that enhanced PPH diagnosis, and innovative tools like wall clocks to record the timing of clinical actions and bells to call for assistance. Challenges included confusion between new and existing medications and record systems that inadequately capture HSC, TXA, and other PPH indicators.

Conclusion and global health implications: HSC and TXA integrated into a PPH intervention package were overall positively valued by providers in humanitarian settings. Continued education and support are crucial. Addressing challenges like medication confusion underscores the need for ongoing education and clear guidelines for the use of HSC, TXA, oxytocin, and other drugs for PPH prevention and treatment. Our findings stress the importance of a comprehensive strategy to overcome health system barriers in PPH management, potentially improving maternal health outcomes in resource-limited and fragile contexts, with broader global implications.

Postpartum hemorrhage (PPH), defined as a blood loss of 500 mL or more within 24 hours after birth, remains the leading cause of maternal mortality globally, accounting for over 20% of all maternal deaths. The burden of mortality from PPH is predominantly in low- and middle-income countries and demands coordinated accelerated efforts from the global maternal health community to meet the Sustainable Development 3 maternal health target by 2030. The International Journal of Maternal and Child Health and AIDS and the Concept Foundation are proud to present this Special Collection demonstrating the evidence for introducing heat-stable carbetocin and tranexamic acid, showcasing the feasibility and acceptability of their utilization for PPH prevention and management in resource-limited high-burden settings.

Background and objective: In Kenya, the leading cause of maternal deaths is obstetric hemorrhage (39.5%), with postpartum hemorrhage (PPH) accounting for 50% with quality of uterotonics as one of the biggest challenges. The World Health Organization (WHO) in 2018 included heat-stable carbetocin (HSC) for the prevention of PPH in settings where the quality of oxytocin cannot be guaranteed. Maintenance of the cold chain for uterotonics is a challenge. HSC does not require refrigeration, reducing pressure on the fragile cold chain infrastructure. The main objective was to understand PPH prevention knowledge, experience, and perspectives, including uterotonic use, by policymakers and healthcare providers (HCPs) in the public health sector in ten counties in Kenya. HCP knowledge, perception, and experience were assessed after the HSC introduction.

Methods: The mixed methods study was implemented in 39 secondary and tertiary public hospitals from ten counties. Quantitative interviews targeting 171 HCPs at baseline and end-line were collected using REDCap software (v5.26.4) and analyzed using Stata version 17. Qualitative data was collected from 19 policymakers at the national, county, sub county, and health facility levels and analyzed using NVIVO 12.

Results: At the end line, 98.8% had administered HSC for the prevention of PPH, while 96.5% of the HCPs were aware that their facilities had protocols/guidelines in place on the use of HSC. To enhance awareness of WHO recommendations on the use of HSC among HCPs, a top-down approach was used. Over 90% of HCPs agreed that HSC was easy to administer and distinguish from other uterotonics. Policymakers agreed that there was value in the HSC introduction in the public health sector that experiences cold chain challenges and recommended budgetary allocation.

Conclusion and global health implications: The findings demonstrate that HCP's knowledge, perception, and experience coupled with the policymaker's perspective is the key to the introduction of HSC in the public sector. Policymakers find value in introducing HSC as it alleviates challenges with the fragile cold chain systems. This study contributes to the global body of knowledge on the introduction of lifesaving commodities, which is anticipated to potentially improve PPH prevention and management, and hence reduce maternal mortality.

Background and objective: Globally, postpartum hemorrhage (PPH) remains the most common direct cause of maternal mortality. This study evaluated the feasibility and acceptability of introducing heat-stable carbetocin (HSC) for PPH prevention and tranexamic acid (TXA) for PPH treatment in five Sub-Saharan African countries following recent World Health Organization (WHO) recommendations. This study also assessed healthcare providers' (HCPs') favorability toward using these medicines.

Methods: We conducted a mixed methods pilot implementation study in selected facilities across Burkina Faso, Ethiopia, Ghana, Sierra Leone, and Uganda between May and December 2022. We compared baseline data obtained from patient registers with data collected during implementation on the safe and appropriate use of HSC and TXA using descriptive statistics. HCP responses were analyzed qualitatively using a thematic analysis.

Results: Following training, HSC was administered prophylactically in 11,329 (92.4%) of 12,262 deliveries in all study facilities which received a uteorotonic for PPH prevention during implementation and was used safely and appropriately. TXA administration for PPH treatment was done safely, appropriately, and within the WHO-recommended time. No adverse events were reported throughout the study. HCPs overall showed high confidence in, and favorability toward, using both medicines.

Conclusion and global health implications: Our study demonstrated that HSC and TXA can be safely and appropriately implemented in primary and tertiary facilities, and their introduction is feasible and acceptable from the perspective of HCPs. A holistic approach to training and regular supportive supervision is needed to ensure the continued safe use of these new and lesser-utilized PPH medicines. Dedicated training is required to improve the documentation of patient charts on PPH care. Introducing these medicines holds promise for improving PPH care in low- and middle-income countries, including by addressing suboptimal efficacy due to cold chain system challenges.

Background and objective: Postpartum hemorrhage (PPH) remains a significant concern in crisis-affected contexts, where the implementation of heat-stable carbetocin (HSC) and tranexamic acid (TXA) for PPH prevention and treatment lacks evidence. This study aims to evaluate the effects of a capacity-strengthening package on the use of uterotonics for PPH prevention and detection, and the use of TXA for PPH treatment in basic maternity facilities in South Sudan.

Methods: In this implementation study, the six chosen facilities followed a stepwise sequence of PPH management: T1 (routine care), a transition period for package design; T2 (package without HSC and TXA); T3 (package and HSC); and T4 (package with HSC and TXA). The intervention comprised refresher training, an online provider community, PPH readiness kits, alarm bells, and displayed algorithms. The main outcomes were trends in prophylactic uterotonic use, including HSC, visual diagnosis of bleeding, and oxytocin and TXA use for PPH treatment. Analyses were adjusted for cluster effect and baseline characteristics. The study was registered in the Pan-African Clinical Trials Registry (PACTR202302476608339).

Results: From February 1, 2022, to February 17, 2023, 3142 women were recruited. Nearly all women received prophylactic uterotonics across all four phases, with a significant increase after T3 (T4-T1: 100%-98%; 95% CI: 4.4-0.4). Oxytocin alone was the most used in T1 (98%) and T2 (94%) and HSC alone in T3 (87%) and T4 (82%) (T4-T1: 95% CI: 75.5-83.3). PPH diagnosis tripled from 1.2% of all births to 3.6% (T2-T1: 95% CI: 0.4-5.2) and stayed roughly at 3% in T3 and T4. For treatment, universal oxytocin use in T1 and T2 decreased in T3 upon HSC initiation (T3-T2: 27%-100%; 95% CI: 95.5-49.9), whereas TXA use increased in T4 (T4-T1: 95%-0%; 95% CI: 54.6-99.0).

Conclusion and global health implications: An intervention package to improve the quality of PPH prevention and treatment can effectively increase HSC and TXA use in crisis settings. It could be scaled up in similar contexts with ongoing supervision to mitigate confusion between the existing and new medications, such as the reduced use of oxytocin for PPH treatment. Sustaining cold chain investments remain vital to ensure oxytocin quality.

Postpartum hemorrhage (PPH) persists as the leading direct cause of maternal mortality in low- and middle-income countries (LMICs) and is a major global health challenge. Following favorable evidence from pivotal efficacy clinical trials, the World Health Organization (WHO) recommends the use of heat-stable carbetocin to prevent PPH as a viable substitute in settings where maintaining a cold chain for thermosensitive uterotonics is compromised, and tranexamic acid as an adjunct therapy for PPH treatment. However, the implementation of these drugs has been hindered by several challenges, such as decentralized and disorganized procurement, poor quality assurance, inadequate supply chain management, and limited access in many LMICs. While including maternal health drugs in the essential medicines list and adopting updated global recommendations are necessary steps forward, they are not enough to guarantee access unless there is end-to-end (E2E) thinking, planning, and execution for essential maternal health commodities. We describe distinct access challenges between the two drugs, both having compelling safety and efficacy data and normative recommendations around the same time; one patent protected and owned by a pharmaceutical company and another with multiple generic manufacturers. We highlight the need for coordinated action to facilitate access to evidence-based maternal health commodities.

Background and objective: Postpartum hemorrhage (PPH) remains a major concern in crisis-affected settings. There is a lack of strategies for implementing heat-stable carbetocin (HSC) and tranexamic acid (TXA) in humanitarian settings. This study aims to investigate the impact of a capacity-strengthening package on the utilization of uterotonics for PPH prevention, PPH detection, and utilization of TXA for PPH treatment in basic obstetric care clinics in humanitarian settings in Uganda.

Methods: A multi-stepped implementation research study was conducted, wherein six select facilities utilized an intervention package encompassing provider training, an online community of practice, and wall-displayed PPH algorithms. Facilities were conveniently assigned to the same study sequence: T1 (routine care), a transition period for training; T2 (package without HSC and TXA); T3 (package with HSC); and T4 (package with HSC and TXA). The primary outcomes assessed trends in prophylactic uterotonic use (including HSC), visual diagnosis of hemorrhage, and HSC and TXA use for hemorrhage treatment. Analysis followed an intention-to-treat approach, adjusting for cluster effect and baseline characteristics. Pan-African Clinical Trials Registry: PACTR202302476608339.

Results: From April 10, 2022, to April 4, 2023, 2299 women were recruited (T1: 643, T2: 570, T3: 580, T4: 506). Over 99% of all women received prophylactic uterotonics across the four phases, with oxytocin alone primarily used in T1 (93%) and T2 (92%) and HSC alone in T3 (74%) and T4 (54%) (T4-T1 95% CI: 47.8-61.0). Hemorrhage diagnosis ranged from 1% to 4%. For hemorrhage treatment, universal oxytocin use in T1 and T2 decreased in T3 and T4 after HSC introduction (T4-T1: 33%-100%; 95% CI: -100.0 to -30.9), and TXA use increased in T4 (T4-T1: 33%-0%; 95% CI: -2.4 to 69.1).

Conclusion and global health implications: An intervention package to reinforce providers' capacity to prevent and treat PPH can result in substantial HSC utilization and a moderate TXA adoption in cold-chain-challenged humanitarian settings. It could be scaled up with continuous capacity development and supportive supervision to mitigate confusion between existing and new medications, such as the decreased use of oxytocin for PPH treatment. Maintaining investments in cold-chain strengthening remains critical to ensure the quality of oxytocin.