The Impact Of Lowdose Aspirin On Reducing The Risk Of Preeclampsia In Highrisk Pregnant Women A Comparative Analytical R

Atef Eid Madkour Elsayed^1*, Yasmeen Noorulislam Abualhussain Albarzan², Wed Alkihder Ahmed Alsaggaf³, Amir Faisal Alenaze⁴, Asrar Fawaz Alanazi⁵, Hania Mohammed Saeed⁶, Abdullah A Ali⁷, Zainab Siddig Gebril Ali⁸, Batool Ahmed Alsubaiti⁹ and Egbal Lutfi Mohamed Salih^10
*Correspondence: Atef Eid Madkour Elsayed, Consultant cardiology King abdelaziz hospital sakaka saudiarabia, Saudi Arabia,

Keywords

Low-dose aspirin, Preeclampsia, High-risk pregnancy, Aspirin prophylaxis, Maternal health, Obstetric hypertension, Pregnancy outcomes, Preventive medicine, Perinatal care, Antenatal intervention

Introduction

Preeclampsia remains one of the most serious hypertensive disorders of pregnancy, characterized by high blood pressure and organ dysfunction, affecting 2–8% of pregnancies worldwide (Espinoza, 2021). The disorder significantly contributes to maternal and neonatal morbidity and mortality, particularly in low-resource settings. Early preventive strategies are essential for mitigating adverse outcomes, especially in high-risk populations. In this context, low-dose aspirin has gained increasing recognition for its potential in reducing the incidence of preeclampsia when administered prophylactically during early gestation.

Multiple international guidelines now recommend low-dose aspirin (LDA) for high-risk women, citing robust data supporting its safety and efficacy (Caritis et al., 1998). The mechanism by which aspirin confers benefit lies in its antiplatelet effects, particularly the inhibition of thromboxane A2, which plays a critical role in the pathogenesis of preeclampsia through vasoconstriction and platelet aggregation. Early intervention, preferably before 16 weeks of gestation, appears vital for optimizing outcomes, as it precedes placentation abnormalities commonly associated with the disease (Horgan et al., 2023).

Emerging evidence from randomized and observational studies supports the importance of aspirin use across various high-risk groups, including women with chronic hypertension, diabetes, autoimmune diseases, or prior preeclampsia (Lin et al., 2022). A trial conducted in China demonstrated a statistically significant reduction in preeclampsia incidence among high-risk women receiving 100 mg of aspirin daily, strengthening the global applicability of aspirin prophylaxis in diverse populations. These findings align with similar conclusions drawn from multicenter trials across Europe and North America.

Despite its benefits, underutilization of aspirin remains a concern. Phelps and Holmgren (2023) found substantial gaps between clinical guidelines and prescribing behaviour, often influenced by variability in risk assessment tools and lack of clinician awareness. This discrepancy underlines the importance of standardized protocols and education to bridge the gap between evidence and practice. Integrating risk stratification models in routine antenatal care could enhance appropriate aspirin utilization.

Beyond efficacy, safety is a critical consideration. A 2024 study by Zhang and Wang reported that LDA did not increase the risk of postpartum haemorrhage, a commonly cited concern among clinicians hesitant to prescribe anticoagulants during pregnancy. The balance of maternal and fetal safety makes aspirin a compelling option, particularly as it poses fewer side effects than other pharmacological alternatives (Zhang & Wang, 2024).

Some researchers have explored dose variations and found that doses ≥100 mg may offer better protection against early-onset or severe preeclampsia. Van Doorn et al. (2021) conducted a meta-analysis comparing different aspirin regimens, concluding that 150 mg doses may be more effective in reducing preterm preeclampsia without increased risk to mother or fetus. This aligns with evolving guidelines advocating for personalized dosing strategies based on risk profile and gestational timing.

While most studies focus on aspirin as a standalone intervention, recent trials have examined its use in combination with other agents such as pravastatin. Eid et al. (2023) reported improved outcomes in high-risk pregnancies when aspirin was paired with pravastatin, suggesting a potential future direction for combination therapy. However, large-scale randomized trials are needed to validate these preliminary findings and inform practice.

Finally, the foundational rationale for aspirin use is firmly grounded in the pathophysiology of preeclampsia. By improving placental perfusion and endothelial function, aspirin addresses key biological pathways implicated in disease onset. As noted by Rossi and Mullin (2011), systematic reviews continue to underscore its value in improving maternal and perinatal outcomes. Thus, ongoing research and guideline harmonization remain essential to maximize aspirin’s life-saving potential in high-risk pregnancies.

Methodology

Study Design

This study employed a systematic review methodology, conforming to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines to ensure transparency, reproducibility, and methodological rigor. The aim was to comprehensively synthesize current empirical evidence on the effectiveness, safety, and dosage variation of low-dose aspirin (LDA) for the prevention of preeclampsia (PE) in high-risk pregnant women. The review focused on peer-reviewed studies reporting primary data and outcomes related to aspirin prophylaxis in obstetric populations, especially targeting the early identification and prevention of preeclampsia before 37 weeks of gestation.

Eligibility Criteria

Studies were selected based on the following pre-specified criteria:

• Population: Pregnant women identified as high-risk for developing preeclampsia (e.g., history of chronic hypertension, diabetes, renal disorders, autoimmune conditions, multiple pregnancies, advanced maternal age).
• Intervention/Exposure: Prophylactic use of low-dose aspirin (ranging from 75 mg to 162 mg daily) administered before or during early gestation (≤20 weeks).
• Comparators: Pregnant women at high risk who did not receive aspirin, received a different dosage, or where the timing of aspirin initiation varied.
• Outcomes: Incidence of preeclampsia, early-onset PE (<34–35 weeks), maternal-fetal outcomes (preterm birth, NICU admission, fetal growth restriction), and safety parameters such as postpartum hemorrhage or neonatal organ development.
• Study Designs: Randomized controlled trials (RCTs), prospective and retrospective cohort studies, case-control studies, and systematic reviews/meta-analyses.
• Language: Only studies published in English were included.
• Publication Period: 1998–2025 to capture both foundational and contemporary evidence.

Search Strategy

A structured and comprehensive search was conducted across the following academic databases:

PubMed, Web of Science, Scopus, Embase, and Google Scholar. Additionally, relevant gray literature sources were examined for preprints and institutional reports.

A combination of Medical Subject Headings (MeSH) and Boolean operators was used, including:

• ("preeclampsia" OR "pre-eclampsia")
• AND ("aspirin" OR "acetylsalicylic acid")
• AND ("low dose" OR "prophylaxis" OR "prevention")
• AND ("pregnancy" OR "gestation" OR "antenatal care")
• AND ("high risk" OR "maternal comorbidity" OR "multiple pregnancy")

Manual searches of the reference lists of retrieved articles and previous reviews were also performed to ensure completeness.

Study Selection Process

Search results were exported into Zotero reference manager. After automated deduplication, titles and abstracts were independently screened by two reviewers, blinded to each other’s selections. Full-texts of potentially eligible studies were retrieved and assessed against inclusion criteria. Disagreements were resolved through discussion and, when necessary, through arbitration by a third reviewer.

The final selection included 27 studies that met all eligibility criteria and were deemed appropriate for qualitative synthesis.

Data Extraction

A standardized data extraction template was developed to capture relevant data from each eligible study. The following variables were recorded:

• Author(s), publication year, and country of study
• Study design and sample size
• Participant characteristics (e.g., age, gestational age, risk factors)
• Aspirin dosage and initiation timing
• Comparator/control group characteristics
• Primary and secondary outcomes (e.g., incidence of PE, neonatal morbidity)
• Confounding variables adjusted for
• Main findings (e.g., odds ratios, relative risks, or effect size)

Data extraction was conducted independently by two reviewers, with validation by a third reviewer to ensure accuracy and completeness.

Quality Assessment

The quality and risk of bias in the included studies were evaluated using tools appropriate to study design:

• Cochrane Risk of Bias Tool for randomized controlled trials
• Newcastle–Ottawa Scale (NOS) for cohort and case-control studies
• AMSTAR-2 criteria for systematic reviews and meta-analyses

Each study was categorized as low, moderate, or high quality, based on participant selection, blinding procedures, outcome assessment, and statistical control for confounding factors.

Data Synthesis

Due to heterogeneity in study designs, aspirin dosages, outcome measures, and risk stratification criteria, a narrative synthesis was employed. Studies were grouped according to:

• Aspirin dosage categories (75 mg, 100–150 mg, 162 mg)
• Timing of administration (before vs. after 16 weeks of gestation)
• Outcome domains (maternal vs. perinatal outcomes)
• Study setting (real-world vs. clinical trial)

Quantitative results such as odds ratios (OR), risk ratios (RR), or hazard ratios (HR) were reported where available, but no meta-analysis was conducted due to lack of standardized effect measures and inconsistent outcome reporting.

Ethical Considerations

As this review involved secondary analysis of published data, no ethical approval or informed consent was required. All included studies were peer-reviewed and assumed to have undergone institutional ethics board approval.

Results

1. Overview of Included Studies and Study Designs

The included studies span diverse methodologies, including prospective cohort studies (Mayrink et al., 2019), randomized controlled trials (Gernand et al., 2017; Kamble & Jamdade, 2025), retrospective cohort analyses (Xiao et al., 2023), population-based case–control studies (Premru‐Srsen et al., 2020), and real-world observational data (Low-dose aspirin in twin pregnancies, 2023). The studies examined various doses of low-dose aspirin (LDA), ranging from 75 mg to 162 mg, administered at differing gestational ages and across different populations, including nulliparas, high-risk singleton pregnancies, and twin gestations.

Sample sizes varied considerably, from as few as 144 participants (Aliasgharpoor et al., 2025) to over 47,000 (Premru‐Srsen et al., 2020), allowing both granular insights and population-wide observations. Study populations included healthy nulliparous women, high-risk pregnancies defined by maternal comorbidities or obstetric history, and diverse ethnic and geographic backgrounds (Slovenia, Brazil, China, Iran).

2. Efficacy of Low-Dose Aspirin in Reducing Preeclampsia Incidence

Several studies demonstrated a positive effect of LDA on reducing preeclampsia risk. Xiao et al. (2023) reported a significant decrease in preeclampsia among high-risk Chinese women taking 75 mg of aspirin daily (OR = 0.40, 95% CI = 0.20–0.82), especially when initiated before 16 weeks. Kamble & Jamdade (2025) showed a 34% reduction in early-onset preeclampsia with 150 mg aspirin initiated between 12 and 20 weeks, alongside improved maternal and fetal outcomes.

Conversely, Premru‐Srsen et al. (2020) found no statistically significant reduction in preeclampsia incidence in nulliparous Slovenian women taking LDA based on current guidelines (OR = 1.308, 95% CI = 0.847–2.022), despite adjusting for propensity scores. A similar lack of efficacy was reported in twin pregnancies, where aspirin use was not associated with reduced preeclampsia rates—likely due to poor compliance (only 14.43% adherence ≥50%) (Low-dose aspirin in twin pregnancies, 2023).

3. Dose and Timing of Aspirin Administration

Dosing regimens varied among studies, contributing to differing outcomes. Rolnik et al. (2022) and Pooh (2024) emphasized that starting aspirin ≤16 weeks at 150 mg nightly significantly reduces the incidence of preterm preeclampsia, as supported by the ASPRE trial. Pullins & Boggess (2025) argued that 162 mg aspirin is more effective than 81 mg, especially in obese women due to altered pharmacokinetics. In contrast, Balhotra & Sibai (2025) defended the continued use of 81 mg, citing historical efficacy with fewer fetal concerns.

A meta-analysis by Chaemsaithong et al. (2020) evaluating aspirin initiated <11 weeks did not find significant reductions in preeclampsia risk but noted potential benefits for reducing preterm delivery, suggesting that timing alone may not be sufficient without dose optimization.

4. Safety and Fetal Impacts

Findings on fatal safety were mixed. Aliasgharpoor et al. (2025) found that aspirin use correlated with smaller fetal kidney size, raising concerns about potential impacts on renal development. Premru‐Srsen et al. (2020) also reported a 42.7% increased odds of SGA neonates in the LDA group (OR = 1.427, 95% CI = 1.001–2.034), further highlighting safety concerns when LDA is administered without stringent risk stratification.

5. Biomarker and Mechanistic Evidence

Nguyen-Hoang et al. (2024) provided longitudinal biomarker insights, showing that LDA improved placental perfusion and reduced vascular resistance rather than directly lowering blood pressure. LDA use was associated with lower uterine artery pulsatility index (UtA-PI), increased placental growth factor (PlGF), and decreased sFlt-1 levels, supporting aspirin’s role in modulating placental vascular pathways.

6. Risk Stratification and Prediction Models

Integration of predictive screening models like those from the Fetal Medicine Foundation (FMF) was advocated by Pooh (2024). These models use maternal characteristics, biomarkers, and uterine artery Doppler indices to identify women likely to benefit from aspirin. Such tools enhance the precision of prophylaxis and may mitigate unnecessary aspirin exposure in low-risk individuals.

Summary of Findings

• Effective prophylaxis: Aspirin (75–150 mg) initiated ≤16 weeks in high-risk women reduces preeclampsia, particularly early-onset PE.
• Dose matters: Doses ≥150 mg may be more effective; 81 mg may be suboptimal in some populations.
• Timing is critical: Initiation before 16 weeks correlates with better outcomes.
• Biomarkers support efficacy: Changes in UtA-PI, PlGF, and sFlt-1 confirm a vascular mechanism.
• Safety concerns: Risk of SGA neonates and reduced kidney development warrants caution in indiscriminate aspirin use.
• Twin pregnancies: LDA may be ineffective without proper compliance or stratification (Table 1).

Discussion

The cumulative evidence from this review reinforces the consensus that low-dose aspirin (LDA), when initiated early in high-risk pregnancies, significantly reduces the risk of preeclampsia (PE). Multiple clinical trials and reviews affirm the utility of LDA in mitigating placental dysfunction and improving maternal-fetal outcomes (Rolnik et al., 2022; Caritis et al., 1998). However, there remains ongoing debate about the optimal dosage, timing, and population targeting, which warrants continued investigation (Balhotra & Sibai, 2025; Pullins & Boggess, 2025).

Aspirin appears to be most effective when initiated before 16 weeks of gestation, as supported by the first-trimester screening model proposed by Pooh (2024) and mechanistic biomarker improvements reported by Nguyen-Hoang et al. (2024). The placental implantation period, occurring in early gestation, is a critical window during which LDA exerts its anti-inflammatory and antiplatelet effects. Conversely, later initiation of aspirin may yield diminished benefits, as placental maladaptation may have already progressed (Chaemsaithong et al., 2020; Firdaus & Ilyas, 2025).

The dosage debate continues to evolve. While the U.S. Preventive Services Task Force currently recommends 81 mg daily, emerging evidence suggests that higher doses such as 150–162 mg may confer superior outcomes, particularly in women with obesity or chronic comorbidities (Pullins & Boggess, 2025; Espinoza, 2021; Van Doorn et al., 2021). Kamble and Jamdade (2025) demonstrated a notable reduction in early-onset PE and intrauterine growth restriction (IUGR) with a 150 mg regimen, supporting this upward shift in dosage. Conversely, Balhotra and Sibai (2025) advocate for continued use of 81 mg, citing lower risk of bleeding complications and sufficient effectiveness when initiated early.

Compliance is another vital determinant of aspirin efficacy. In the twin pregnancy study from China, although aspirin was prescribed to a high-risk cohort, poor adherence (particularly in rural subgroups) undermined the drug’s preventive impact (Low-dose aspirin in twin pregnancies, 2023). This aligns with findings from Lake et al. (2024), who identified knowledge and adherence gaps among obstetric care providers in low- and middle-income countries as a key barrier to LDA implementation.

Importantly, the safety of LDA remains a key concern. While the majority of studies affirm its favorable safety profile, some nuanced risks have been reported. Aliasgharpoor et al. (2025) found a significant reduction in fetal renal size associated with aspirin use, suggesting possible adverse effects on nephrogenesis. Similarly, Zhang and Wang (2024) flagged a potential increase in postpartum haemorrhage, though such outcomes remain infrequent and largely dose-dependent. These findings underscore the importance of personalized aspirin therapy, with dose and duration carefully tailored to maternal physiology and fetal development.

Biomarker studies offer promising avenues for refining aspirin's role. Nguyen-Hoang et al. (2024) observed that LDA improved placental antigenic markers such as PlGF and sFlt-1 without affecting maternal blood pressure, suggesting vascular remodeling rather than antihypertensive mechanisms. Eid et al. (2023) expanded on this, showing synergistic effects when LDA was paired with pravastatin in high-risk patients, although such strategies remain investigational.

The heterogeneity in population response is another critical theme. Mayrink et al. (2019) reported that in otherwise healthy nulliparous women, factors like BMI and diastolic pressure were more predictive of PE than aspirin use. Similarly, Premru‐Srsen et al. (2020) found no significant reduction in PE incidence with LDA, but an increased risk of small-for-gestational-age (SGA) infants, suggesting that aspirin’s effects may vary by maternal baseline health and ethnic background. This is consistent with Henderson et al. (2014), who called for better patient stratification in aspirin trials.

Recent updates in pathophysiology further support aspirin’s multifaceted potential. Lee et al. (2025) described how LDA targets platelet aggregation, prostaglandin imbalance, and endothelial dysfunction, all central to preeclampsia pathogenesis. Gernand et al. (2017) highlighted the modulating role of vitamin D status, suggesting that adjunct therapies may optimize aspirin efficacy. These emerging insights could pave the way for multimodal prophylaxis protocols in the future.

Despite these advances, systemic inequities in maternal healthcare still limit the global impact of LDA. Dickerson et al. (2025) emphasized how racial disparities, socioeconomic constraints, and provider biases contribute to differential access and underuse of aspirin therapy in marginalized populations. Similarly, Phelps and Holmgren (2023) reported under-prescription of LDA among women with complex risk profiles. Closing this implementation gap will require not only clinician training, but structural reforms in antenatal care systems.

In sum, low-dose aspirin represents a cornerstone of PE prevention, but its effectiveness hinges on early initiation, adequate dosing, patient selection, and compliance. While 75–150 mg has shown strong promise, further stratified studies are needed to validate dose-response thresholds and monitor potential adverse fetal outcomes. The future of preeclampsia prevention lies in precision medicine approaches, combining biomarkers, clinical algorithms, and socioeconomic considerations to tailor aspirin use across diverse global populations.

Conclusion

This review substantiates the pivotal role of low-dose aspirin (LDA) in the primary prevention of preeclampsia among high-risk pregnancies. Across diverse geographical and clinical settings, LDA-particularly when initiated before 16 weeks of gestation—demonstrates consistent reductions in the incidence of both early and late-onset preeclampsia. Despite ongoing debates regarding the optimal dose, findings favor tailored prophylaxis within the range of 75–162 mg, especially for populations with additional comorbid risk factors. Early initiation, appropriate dosage, and patient adherence are essential components of effective aspirin prophylaxis.

However, the successful integration of LDA into maternal health programs is influenced by broader health system dynamics, including provider knowledge, healthcare infrastructure, and patient education. Moreover, emerging concerns related to fetal safety and variable biomarker responses signal the need for more individualized approaches. A comprehensive, evidence-informed strategy that incorporates clinical, physiological, and socioeconomic variables is necessary to fully leverage the benefits of aspirin while minimizing associated risks.

Limitations

Several limitations should be acknowledged. First, the heterogeneity among studies—ranging from dosage differences and initiation timing to population risk profiles—precluded the possibility of conducting a formal meta-analysis. Second, many included studies lacked long-term neonatal outcome data, limiting the understanding of aspirin’s extended safety profile. Third, although efforts were made to include global studies, literature from some low-income countries remains sparse or underreported. Additionally, variation in outcome definitions (e.g., early vs. severe PE) introduced potential inconsistencies in data interpretation. Finally, publication bias may have led to an overrepresentation of positive findings.

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