Publications by Year: 2025

RATIONALE: Despite World Health Organization (WHO) guidelines for preventing, detecting, and treating postpartum hemorrhage (PPH), effective implementation has lagged.

OBJECTIVES: To evaluate the clinical benefits and harms of implementation strategies used to promote adherence to WHO clinical guidelines for the prevention, detection, and treatment of PPH.

SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and two trial registries, along with reference checking, citation searching, and contact with study authors. The latest search date was 25 April 2024.

ELIGIBILITY CRITERIA: We included randomized controlled trials (RCTs), including cluster, pragmatic, and stepped-wedge designs, and non-randomized studies of interventions (NRSIs), including interrupted time series (ITS) studies, controlled before-after (CBA) studies, and follow-up (cohort) studies containing concurrent controls that focused on or described implementation strategies of WHO guidelines for the prevention, detection, and treatment of PPH. Participants were birth attendants and people giving birth in a hospital or healthcare facility. We excluded studies that did not implement a WHO PPH recommendation, had no comparator group, or did not report clinical/implementation outcomes.

OUTCOMES: Our critical outcomes were: adherence to WHO-recommended guidelines for PPH prevention, detection, and treatment; PPH ≥ 500 mL; PPH ≥ 1000 mL; additional uterotonics within 24 hours after birth; blood transfusions; maternal death; severe morbidities (major surgery; admission to intensive care unit [ICU]); and adverse effects (variable and related to the clinical intervention) during hospitalization for birth. Our important outcomes were: breastfeeding at discharge; implementation outcomes such as acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability of the implementation strategy; and health professional outcomes such as knowledge and skill.

RISK OF BIAS: We used the RoB 2 and ROBINS-I tools to assess risk of bias in RCTs and NRSIs, respectively.

SYNTHESIS METHODS: Two review authors independently selected studies, performed data extraction, and assessed risk of bias and trustworthiness. Due to the nature of the data, we reported relevant results for each comparison and outcome but did not attempt quantitative synthesis. We used GRADE to assess the certainty of evidence.

INCLUDED STUDIES: We included 13 studies (9 cluster-RCTs and 4 NRSIs) with a total of 1,027,273 births and more than 4373 birth attendants. The included studies were conducted in 17 different countries. Most trials were conducted in resource-limited settings. None of the included studies reported data on the use of additional uterotonics within 24 hours after birth or adverse effects.

SYNTHESIS OF RESULTS: Single-component implementation strategies versus usual care for PPH prevention, detection, and treatment We do not know if single-component implementation strategies have any effect on adherence to WHO PPH prevention recommendations, PPH ≥ 500 mL, PPH ≥ 1000 mL, or blood transfusion (very low-certainty evidence). Low-certainty evidence suggests that single-component implementation strategies may have little to no effect on maternal death (86,788 births, 3 trials); may increase severe morbidity related to ICU admission (26,985 births, 1 trial); and may reduce severe morbidity related to surgical outcomes (26,985 births, 1 trial). No trials in this comparison measured the effect on adherence to WHO treatment guidelines. Multicomponent implementation strategies versus usual care for PPH prevention, detection, and treatment We do not know if multicomponent implementation strategies have any effect on adherence to WHO PPH treatment recommendations, PPH ≥ 500 mL, blood transfusion, or severe morbidity relating to surgical outcomes (very low-certainty evidence). Multicomponent implementation strategies may have little to no effect on maternal death (274,008 births, 2 trials; low-certainty evidence) compared to usual care. No trials in this comparison measured the effect on adherence to WHO PPH prevention recommendations, PPH ≥ 1000 mL, or severe morbidity (outcomes related to ICU admission). Multicomponent implementation strategies versus enhanced usual care for PPH prevention, detection, and treatment Low-certainty evidence suggests that multicomponent implementation strategies may improve adherence to WHO PPH prevention recommendations (14,718 births, 2 trials) and adherence to WHO PPH treatment recommendations (356,913 births, 2 trials) compared to enhanced usual care. Multicomponent implementation strategies probably have little to no effect on maternal death (224,850 births, 2 trials; moderate-certainty evidence), severe morbidity related to ICU admission (224,850 births, 2 trials; moderate-certainty evidence), and surgical morbidity (210,132 births, 1 trial; moderate-certainty evidence) compared to enhanced usual care. We do not know if multicomponent implementation strategies affect PPH ≥ 500 mL, PPH ≥ 1000 mL, or blood transfusion (very low-certainty evidence).

AUTHORS' CONCLUSIONS: Multicomponent implementation strategies may improve adherence to WHO PPH prevention and treatment recommendations, but they probably result in little to no difference in ICU admissions, surgical morbidity, or maternal death. The majority of available evidence is of low to very low certainty, thus we cannot draw any robust conclusions on the effects of implementation strategies for WHO guidelines to prevent, detect, and treat PPH. While all included studies used the implementation strategy of 'train and educate,' the effects seem to be limited when used as a single strategy. Additional research using pragmatic, hybrid effectiveness-implementation study designs that measure implementation outcomes simultaneously alongside clinical outcomes would be beneficial to understand contextual factors, barriers, and facilitators that affect implementation.

FUNDING: This Cochrane review had no dedicated external funding. Dr Rose Molina, who is employed by Beth Israel Deaconess Medical Center, received funding from Ariadne Labs (Harvard T.H. Chan School of Public Health, Brigham and Women's Hospital) for her time. As a funder, Ariadne Labs had no involvement in the development of the protocol or conduct of the review. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of Ariadne Labs.

REGISTRATION: Registration: PROSPERO (CRD42024563802) available via https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024563802.

OBJECTIVE: To measure the association between restricted abortion access and maternal and infant health by maternal nativity (whether they were born in the US).

DESIGN: Observational population-based retrospective cohort study.

SETTING: United States.

POPULATION: All births (N = 33 663 837) in the United States from 2011 to 2019.

METHODS: We use Centers for Disease Control and Prevention (CDC) Period Linked Birth/Infant Deaths datafiles, with a dataset of state-level abortion restrictions (Targeted Restrictions on Abortion Providers (TRAP) laws) to estimate the association between restricted abortion access and maternal and infant health by maternal nativity. We examine restricted abortion access and maternal nativity in a triple-differences framework.

MAIN OUTCOMES MEASURES: The primary outcome we examine is maternal morbidity (defined by the CDC as any delivery involving third- or fourth- degree perineal laceration, ruptured uterus, unplanned hysterectomy, or maternal admission to intensive care). We also explore several secondary factors associated with maternal and infant health (birth interval, birth weight, receiving care in the first trimester, and gestational age at birth).

RESULTS: While we find no impact of TRAP laws on non-immigrants, foreign-born individuals in states with TRAP laws have 15% higher odds of maternal morbidity (aOR = 1.15; CI = 1.00-1.31) compared to US-born individuals in states without TRAP laws.

CONCLUSIONS: Anti-abortion legislation can worsen existing inequalities in maternal and infant health. These findings underscore the urgent need for policies that ensure equitable access to reproductive healthcare for immigrant populations.

IMPORTANCE: The US has the highest rate of preganncy-related death among high-income countries, and disparities continue to widen despite many of these deaths being largely preventable.

OBJECTIVE: To examine the age-standardized national rates of pregnancy-related death from 2018 to 2022 in the US, stratified by cause, and to compare the rates across state and race and ethnicity.

DESIGN, SETTING, AND PARTICIPANTS: This serial cross-sectional study used nationwide data on births and pregnancy-related deaths from the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research. All pregnancy-related deaths among women aged 15 to 54 years from 2018 to 2022 were included.

EXPOSURE: State, race and ethnicity, and age.

MAIN OUTCOMES AND MEASURES: The primary outcomes were all-cause and cause-specific maternal death and late maternal death (ie, deaths occurring >42 days and up to 1 year after pregnancy). The age-standardized annual and aggregated rate of pregnancy-related mortality (ASR) was estimated by age group and race and ethnicity, and state-specific crude pregnancy-related mortality rates per 100 000 live births and 95% CIs were calculated.

RESULTS: During 2018 to 2022, there were 6283 pregnancy-related deaths, including 1891 late maternal deaths. The ASR increased by 27.7% from 25.3 deaths per 100 000 live births (95% CI, 23.7-26.9) in 2018 to 32.6 deaths per 100 000 live births (95% CI, 31.2-34.8) in 2022. The increase was observed across age group and was disproportionately driven by deaths that occurred among women aged 25 to 39 years (by 36.8%, 2018 vs 2022). There was a considerable variation in rates by state, ranging from 18.5 to 59.7 deaths per 100 000 live births. If the national rate was reduced to the lowest state rate, 2679 pregnancy-related deaths could have been prevented in 2018 to 2022. American Indian and Alaska Native women had the highest ASR (106.3 deaths per 100 000 live births), followed by non-Hispanic Black women (76.9 deaths per 100 000 live births). Although cardiovascular disease was the leading cause of the overall pregnancy-related deaths, cancer, mental and behavior disorders, and drug-induced and alcohol-induced death were important contributing causes of late maternal death.

CONCLUSIONS AND RELEVANCE: In this cross-sectional analysis of pregnancy-related deaths in the US, rates increased during 2018 to 2022, with large variations by state and race and ethnicity. The concerning rates in the US should be an urgent public health priority.

BACKGROUND: Engaging patients in quality improvement and innovation projects is increasingly important, yet challenges persist with involving patients who speak languages other than English. This article presents design activities our team used to engage Spanish-speaking patients and cultural brokers.

OBJECTIVE: To develop a clinician communication tool to enhance patient trust in pregnancy care clinicians, especially among minoritized populations who face language and cultural barriers, using human-centered design (HCD).

PATIENT INVOLVEMENT AND INNOVATION: We centered end-user experiences, including clinicians, Spanish-speaking patients, and Spanish-speaking cultural brokers, in our design process through multiple feedback sessions and modalities.

METHODS: We used a HCD process to understand the problem, co-design a tool, and prepare for testing of a clinician tool. Design activities included a critical literature review, user interviews, design principles, solution sketching, rapid cycle feedback with subject matter experts, and field experience with pregnancy clinicians.

RESULTS: We innovated on a widely used clinical communication tool, the Four Habits Model, and developed the Five Habits for Pregnancy Care to support pregnancy care clinicians in building trust by bridging cultural and language differences. We added an equity-focused habit "Pause and Reflect" to bookend the Four Habits. We refined the tool to meet different needs across pregnancy care visits based on feedback from 7 clinicians.

DISCUSSION: We applied equity principles in a HCD process to understand a problem, co-design a tool, and prepare for testing by engaging with patients and cultural brokers in Spanish. Balancing the differing approaches for designers and researchers yielded important insights for enhancing equitable processes and outcomes in healthcare improvement.

PRACTICAL VALUE: Communication tools designed with and for minoritized populations are critical for improving trust in all patient-clinician dyads during pregnancy care.