Saffron and Pregnancy: Cultural Practices,Beliefs,and Safety Evidence: An Integrative Review

Abstract

Background

Crocus sativus L. is a culturally significant herbal remedy used by pregnant women in many regions, particularly in South Asia and the Middle East. Despite its widespread use, evidence regarding its clinical efficacy and safety profile remains limited and inconclusive.

Objectives

This integrative review aims to synthesize cultural beliefs, reported use, and clinical evidence on saffron use during pregnancy and childbirth, and to critically evaluate evidence regarding its maternal and fetal safety and therapeutic potential.

Methods

A systematic search of PubMed, Google Scholar, Scopus, and Web of Science was conducted to identify English-language articles from inception to June 2025. Included studies comprised clinical trials, observational studies, systematic reviews, and cultural accounts. Data were extracted on cultural beliefs, use patterns, clinical outcomes, and potential risks. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework guided study selection.

Results

Twelve studies were selected. Cultural practices strongly influence saffron use, with women consuming it to improve fetal complexion, maternal strength, and labor readiness. Clinical evidence indicates low-dose saffron (approximately 250 milligrams daily) may facilitate cervical ripening, reduce labor pain and anxiety, and shorten labor duration in term pregnancies. These effects are dose-dependent, with higher doses or occupational exposure linked to uterine stimulation and increased miscarriage risk.

Conclusions

Low-dose saffron shows promise for improving labor outcomes, though excessive consumption poses significant risks. Saffron use is deeply rooted in cultural beliefs, underscoring the need for respectful, dialogue-based approaches to guide patients safely. Standardized preparations and long-term safety data are needed before clinical recommendations can be made.

Keywords

pregnancy labor pain cervical ripening plant extracts occupational exposure anxiety herbal medicine

Introduction

Childbirth is characterized by excruciating pain. It is often considered as one of the most intense experiences a woman may endure.¹ Consequently, the fear of this pain contributes to an increased preference for cesarean delivery.² It triggers increased fear and anxiety, which signals the sympathetic nervous system into a fight-or-flight response. This releases hormones such as epinephrine, norepinephrine, and cortisol.³

However, this response suppresses the release of oxytocin, which impacts the labor process, often increasing its duration and subsequently adding more pain.⁴ Prolonged labor is also reported when fear and pain collectively lead to reactive pelvic floor muscle contraction.⁵

Medical conditions associated with prolonged labor increase the maternal mortality rate, particularly in developing countries. These include endometritis, fetal distress, abnormal uterine contraction, and postpartum hemorrhage.^6,7

Maternal healthcare demands reduced labor duration and pain severity. Various methods achieve these goals, including pharmacological interventions and medicinal herbs.^8–10 Many pharmacological regimens reduce pain and manage labor efficiently. However, they also bear potential side effects on maternal and fetal health, sometimes leading to associated morbidity and mortality.^11,12

Herbal medicine during pregnancy is widely practiced globally. Studies from diverse geographical regions document varying prevalence rates and cultural patterns. Research from Nigeria, Ghana, and other African nations reports herbal medicine use ranging from 26% to 80% among pregnant women, often driven by cultural beliefs and accessibility challenges to conventional healthcare.^13–15 Similarly, studies from Iran, India, and Middle Eastern countries demonstrate comparable patterns of herbal use, with saffron being particularly prominent in Persian and Ayurvedic traditional medicine systems.^16,17 European and North American studies report lower but substantial prevalence rates of 7% to 36%, with increasing trends linked to preferences for natural therapies.^18,19

Despite this widespread use, a significant knowledge gap exists regarding the safety and efficacy of most herbal preparations during pregnancy. The majority of herbal medicines lack rigorous clinical trials, standardized dosing protocols, and comprehensive safety data specific to pregnant populations.^20,21 This gap is particularly concerning given the vulnerability of the maternal-fetal unit and the potential for herb-drug interactions or adverse effects on pregnancy outcomes. Current evidence synthesis efforts remain fragmented, with limited integration of clinical data with cultural practices and traditional knowledge systems.

This integrative review situates itself within this knowledge gap by systematically synthesizing available evidence on saffron use during pregnancy and childbirth. It uniquely integrates clinical trial data with cultural practices and traditional beliefs, providing a comprehensive perspective currently absent in the literature. Therefore, it is critically needed to carefully evaluate existing literature on saffron's impact on pregnancy and childbirth in conjunction with cultural and traditional knowledge and practices.

The investigation of medicinal herbs with potential to reduce pain and shorten labor duration represents a significant area of development in midwifery care. Present-day research focuses on revealing the underlying mechanisms of potential medicinal herbs, especially regarding severe pain associated with childbirth.²² Herbal medicine is defined as any part, product, component, and material containing bioactive compounds from these herbs.²³

One highly sought medicinal plant worldwide is saffron (Crocus sativus L.). It is traditionally considered a valuable spice due to its characteristic aroma, flavor, and pharmacological attributes from constituent bioactive components.²⁴

Saffron has symbolic importance in various traditional belief systems and cultures worldwide, particularly in South Asian and Middle Eastern regions. As the world's most expensive spice by weight, often referred to as “Red Gold,” saffron's considerable economic value further elevates its status within traditional medicine systems, where costly remedies are frequently associated with potency and prestige. Historically, saffron has been part of many cultural belief systems that regard it highly for its impact on mood, digestion, and reproductive health. In the context of pregnancy, saffron's efficacy is rooted in some cultures that utilize it to enhance maternal and fetal well-being.²⁵

Saffron is also widely studied for its potential benefits like labor pain reduction and as an analgesic that helps relax smooth muscle contraction to facilitate quicker labor advancement.^26,27

However, this efficacy is often contradicted. While cultural beliefs are aligned that saffron tends to improve pregnancy, childbirth, and fetal development,²⁸ its scientific evaluation remains scarce. There are limited studies illustrating saffron's widespread efficacy, such as its antioxidant properties or potential impact on mood.^29,30

This is opposed by risk-related findings that underscore its abnormal or increased consumption results in abortion or abnormal uterine contractions.²⁸ Currently, clinical studies are being actively conducted to test saffron's potency related to pregnancy. Randomized controlled trials have shown experimental cervical ripening induced through saffron intervention at term.^31,32

This integrative review examines current evidence on saffron use during pregnancy, focusing on its therapeutic potential, safety, and significance in cultural and traditional practices. It aims to synthesize research on saffron's effects during labor and childbirth, exploring both benefits and risks. The review also investigates cultural and traditional beliefs that shape perceptions of saffron's role in pregnancy and childbirth. Additionally, it identifies gaps in clinical practice and literature regarding saffron's potential to improve pregnancy outcomes, highlighting areas where further research and evidence-based guidance are needed.

Methodology

Study Design

This study employed an integrative review methodology to assess saffron's application in pregnancy, associated risks and benefits, traditional and cultural perspectives of saffron utilization, and its safety profile. The PRISMA framework was used to ensure the study adhered to higher standards of synthesizing literature.

Search Strategy

Major electronic databases, including Google Scholar, PubMed, Scopus, and Web of Science were accessed from their inception to June 2025, to retrieve relevant literature aligning with research aims and objectives. A well-defined search strategy was curated using specific keyword combinations to maximize search quality. Several keyword combinations like “Saffron,” “Crocus sativus,” “Pregnancy,” “Herbal Medicine,” “Maternal Health,” “Complementary and Alternative Medicine,” and “Safety” were employed to yield the desired outcome. To enhance alignment of retrieved literature with research objectives, Boolean operators (“AND,” “OR”) were also utilized. The search strategy used in all databases is summarized in Table 1.

Table 1.

Defined Search Strategy.

Databases	Search String	Boolean Operators
PubMed	(“Crocus” OR “Saffron” OR “Crocus Sativus”) AND (“Pregnancy” OR “Pregnant Women” OR “Maternal Health” OR “Maternal” OR “Labor”) AND (“Phytotherapy” OR “Medicine, Traditional” OR “Herbal Medicine” OR “Safety” OR “Risk” OR “Efficacy”)	AND, OR
Scopus	(“Saffron” OR “Crocus Sativus”) (“Pregnancy” OR “Pregnant” OR “Gestation” OR “Maternal Health” OR “Childbirth” OR “Labor”) (“herbal medicine” OR “Traditional Medicine” OR “Phytotherapy” OR “Cultural Belief” OR “Safety” OR “Risk” OR “Abortifacient” OR “Uterotonic”)	AND, OR
Web of Science	(“Saffron” OR “Crocus Sativus”) AND (“Pregnancy” OR “Pregnant” OR “Gestation” OR “Maternal Health” OR “Obstetric” OR “Prenatal” OR “Antenatal”) AND (“Herbal Medicine” OR “Complementary Therapy” OR “Traditional Medicine” OR “Cultural Practice” OR “Safe” OR “Risk” OR “Toxic”)	AND, OR
Google Scholar	(“Saffron” OR “Crocus Sativus”) AND (“Pregnancy” OR “Pregnant” OR “Maternal Health” OR “Labor” OR “Childbirth”) AND (“Herbal Medicine” OR “Traditional Medicine” OR “Safety” OR “Risk” OR “Cultural Practice” OR “Efficacy”)	AND, OR

Inclusion Criteria

Pre-defined inclusion criteria were established to ensure the retrieved literature aligns with required quality and relevance to research goals (Table 2). It included studies that were peer-reviewed while with key objective being the use of saffron during pregnancy and cultural and traditional beliefs of its perceived benefits. Inclusion criteria allowed a number of methodological designs to be selected, encompassing clinical trials, reviews, and observational studies among others. Studies published in the English language were included. Selection criteria also ensured the full-text availability of selected literature.

Table 2.

Protocol for Study Selection.

Criteria	Inclusion	Exclusion	Justification
Population	Studies involving pregnant women, women in labor, or related to maternal health outcomes.	Studies focused on non-pregnant populations, animal models (preclinical) without human relevance, or exclusively on male subjects.	The review's focus is explicitly on pregnancy and maternal health. Animal studies are excluded unless they provide crucial pharmacological insight directly addressed in the review's aims.
Concept	Studies investigating the use, role, effects (beneficial or adverse), cultural beliefs, or knowledge regarding saffron (Crocus sativus).	Studies where saffron is not a primary focus (eg, mentioned only in a long list of other herbs without specific data).	To ensure the synthesized data is directly relevant to understanding saffron's specific role, rather than herbal medicine in general.
Context	Use during pregnancy, childbirth, or the postpartum period in any cultural or healthcare setting.	Use of saffron in contexts unrelated to reproduction or maternal health (eg, cancer, depression in general population).	The scope of the review is defined by the perinatal period and its associated health practices and beliefs.
Study Design	Peer-reviewed primary studies: randomized controlled trials, observational studies (cohort, case-control), cross-sectional surveys, qualitative studies. Also includes systematic reviews.	Conference abstracts, editorials, opinion pieces, letters without original data, non-peer-reviewed sources (eg, blogs, magazines).	To ensure the inclusion of empirically sound and methodologically rigorous evidence that can be critically appraised. Grey literature is excluded for quality control.
Language	Articles published in the English language.	Articles published in languages other than English.	Due to practical constraints of the research team (lack of resources for translation). This is a common limitation in systematic reviews.
Data	Full-text document is accessible and available.	Studies where the full text is unavailable after exhaustive attempts to retrieve it (eg, through inter-library loan).	Necessary for complete data extraction and quality assessment.
Time Frame	All studies from the inception of the databases until the search date (June 2025).	N/A (No date restriction was applied).	To capture the entire evolution of scientific and cultural knowledge on the topic, from historical context to the most recent evidence.
Outcome	Studies reporting on any maternal, fetal, or labor-related outcome, cultural practices, or safety concerns.	Studies that do not report on outcomes relevant to maternal health, pregnancy, or saffron use.	To align with the review's objectives of synthesizing evidence on efficacy, safety, and cultural practices.

Exclusion Criteria

Studies published in languages other than English, lacking focus on maternal outcomes or safety, were excluded. Additionally, conference abstracts, opinion papers, or non-peer-reviewed sources were not considered in the selection criteria.

Study Selection

Studies were selected in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework to ensure a robust and transparent approach. The selection process was conducted by two independent reviewers. The initial database search yielded a total of 612 articles. After the removal of duplicates (148 articles), the titles and abstracts of 464 records were screened against the inclusion and exclusion criteria. A full-text review of the remaining 148 studies was conducted to assess eligibility. Any disagreements between the reviewers at any stage of the selection process were resolved through discussion and consensus or by consultation with a third reviewer. Ultimately, 136 studies were excluded, and 12 studies were selected that met all the inclusion criteria. The complete study selection process is illustrated in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart presented in Figure 1.

Figure 1.

PRISMA 2020 flowchart for study selection.

Data Extraction and Analysis

Relevant data were extracted by two independent reviewers using a standardized data extraction form. Data extracted included study characteristics (author, year, design), cultural beliefs and knowledge, reported use, clinical evidence, and risks or safety concerns. Any discrepancies in the extracted data were resolved through discussion until consensus was reached. The extracted data were then analyzed thematically to identify recurring patterns, converging themes, and diverging findings across the selected studies. Thematic analysis was selected as the analytical approach because it allows for the identification of recurring patterns and converging themes across heterogeneous study designs, which is essential for integrative reviews that synthesize diverse forms of evidence including quantitative clinical trials, qualitative cultural studies, and observational research. This approach enabled the systematic organization of findings while preserving the nuanced interplay between clinical efficacy data and cultural context.

Results

Study Characteristics

Twelve studies focusing on the use of saffron (Crocus sativus L.) for labor pain and childbirth were selected for this integrative review. Study designs of selected studies for the synthesis of literature encompassed varying study designs, where the majority of included studies were randomized controlled trials,^26,27,32 a prospective case-control study,³¹ and observational or review studies.^20,21,28,30 Studies reported diverse findings on labor duration, pain and anxiety reduction, cervical ripening, cultural practices and beliefs, and safety profiles. Evidence synthesized from randomized controlled trials was crucial for understanding the impact of efficacy of saffron in the childbirth process, while observational and review studies supplemented significant findings regarding prevalence, traditional use, and associated safety concerns (Table 3).

Table 3.

Summary of Knowledge, Beliefs, use, and Evidence of Saffron During Pregnancy.

Author (Year)	Cultural Beliefs & Knowledge	Reported Use	Clinical Evidence	Risks / Safety Concerns
Engelin (2009)³³	Consumed from the sixth month in South India to ensure a fair-skinned baby. Belief it improves fetal complexion.	Oral consumption during pregnancy.	Qualitative study: Documents cultural practices and beliefs. No clinical efficacy or safety data provided.	Identifies harmful associated practices (eg, water restriction), but not specifically for saffron.
Hosseinzadeh & Nassiri-Asl (2013) ³⁰	Traditional use as an emmenagogue, to induce labor, and in high doses as an abortifacient.	High doses (more than 10 grams) are used in ethnomedicine to terminate pregnancy.	Review: Affirms antidepressant efficacy (30 milligrams per day). Discusses mechanism: Animal studies show uterine contractions likely due to smooth muscle stimulation.	High doses (more than 5 grams) can be toxic; 20 grams may be fatal. Use for abortion causes severe side effects (bleeding, vertigo).
Ajam et al (2014)³¹	Persian medicine describes saffron as an emmenagogue, labor inducer, and abortifacient (Avicenna's Canon).	Occupational exposure (inhalation or dermal) during farming and processing activities.	Case-Control: Significantly higher miscarriage rate in the exposed group (10.6% vs 0%).	High exposure is a risk factor for miscarriage. Pregnant women, especially farmers, should avoid contact.
Sadi et al (2016)³²	The belief that moderate use after first trimester facilitates labor by promoting uterine tissue elasticity.	250 milligram tablets every 8 h for 24 h at term.	Randomized controlled trial: Significantly improved Bishop score. Non-significant trends towards shorter labor and better neonatal outcomes.	No adverse events reported at this dosage. References occupational study (Ajam et al, 2014) for miscarriage risk.
Ahmadi et al (2017)²⁶	Rooted in Traditional Persian Medicine (Avicenna, Rhazes) for easing labor pain and facilitating childbirth.	Oral saffron stigma powder (250 milligrams every 2 h, maximum 3 doses) during active labor.	Randomized controlled trial: Significantly reduced labor pain and anxiety. Shortened duration of the first and second stages of labor. Faster cervical dilation.	No maternal or neonatal complications were reported at the used dosage. The study excluded high-risk pregnancies.
Alsous et al (2021)³⁴	The belief that herbs have fewer side effects than conventional medicine. The main reason for avoidance is fear of abortion.	32.14% of pregnant women used herbs for conditions like pain, cough, and nausea.	Cross-sectional survey: Captures perceptions and prevalence of herbal use. Not specific to saffron.	2.1% of self-medicating users reported a harmful effect. The primary safety concern is the risk of abortion.
Ali-Akbari Sichani et al (2020)²⁷	Used in Iranian traditional medicine to induce labor. Mentioned in traditional Chinese medicine for gynecological issues.	250 milligrams per day oral capsules for 3 days at term.	Randomized controlled trial: Improved Bishop score, shorter labor stages, less oxytocin use, and reduced maternal hemorrhage.	Adverse effects in intervention group: weakness, lethargy, erythema (1 case); palpitations and nausea (2 cases).
Bernstein et al (2021)²⁰	Widespread belief that “natural” equals “safe.” Part of global herbal use in pregnancy (7 to 73% prevalence).	Not specific to saffron. Documents use of herbs like raspberry leaf for labor, ginger for nausea.	Review: Highlights the general lack of safety and efficacy data for most herbs in pregnancy.	General risks: abortifacient, teratogenic effects, contaminants. Warns against the assumption of safety.
Abadibavil & Dashti (2021)³⁵	Indigenous use in Iranian cultures for labor management. Grounded in traditional knowledge.	Oral capsules (250 milligrams) or syrup at the onset of active labor.	Review of 6 randomized controlled trials: Reduces labor pain, anxiety, fatigue; shortens labor duration; improves cervical ripening.	No serious side effects (eg, abortion) were reported in clinical trials at a 250 milligram dose. Calls for more safety research.
Butnariu et al (2022)²⁸	Used in Ayurveda or Persian medicine for mood and fetal health; high doses are used to induce abortion.	Cultural use varies from low doses for wellness to high doses for abortion.	Review: Discusses mechanism: Animal studies show uterotonic effects, potentially mediated by stimulation of uterine smooth muscle, leading to fetal weight reduction, resorption, and abortion at high doses.	Not recommended in therapeutic doses during pregnancy due to abortifacient risk. Safety is not established.
Iranifard et al (2022)³⁶	Used in Iranian or Indian medicine to ease delivery and as an adaptogen against stress.	Oral capsules (250 milligrams) or syrup during late pregnancy or labor.	Meta-Analysis: Significantly reduces anxiety, improves Bishop score, and shortens first and second stage labor.	Nausea was a common side effect. Lack of comprehensive safety data is a major limitation.
Kamel et al (2022)²⁹	Used in Morocco for intestinal bloating, pain, to ease childbirth (accelerate labor), and for stress or anxiety.	Infusion, decoction, or raw. Used in the second and third trimester and during childbirth.	Ethnobotanical survey: Documents traditional use patterns. Does not provide clinical evidence on efficacy.	Highlights the general risks of herbal medicine use in pregnancy due to a lack of safety data and regulation.

Thematic Analysis

Theme 1: Use of Saffron During Pregnancy and Childbirth

Clinical use patterns documented across studies revealed that saffron is administered in various forms and dosing regimens. Randomized controlled trials primarily employed oral capsules containing 250 milligrams of saffron stigma powder, administered either as a single daily dose or divided doses every 2 to 8 h.^26,27,32 The timing of administration varied, with some studies initiating saffron at the onset of active labor and others beginning treatment 24 to 72 h before anticipated delivery at term (37 to 40 weeks gestation).

Traditional use patterns differ from clinical trial protocols. Ethnobotanical surveys document diverse preparation methods including infusions, decoctions, raw consumption, and incorporation into food and beverages.²⁹ In South Indian communities, women typically begin consuming saffron from the sixth month of pregnancy, mixing small amounts in milk or warm water.³³ Moroccan traditional practices involve saffron use during the second and third trimesters, particularly at childbirth to “accelerate labor” and reduce stress.²⁹

Dosing in traditional contexts lacks standardization. Women rely on family knowledge, community recommendations, or traditional birth attendants rather than consulting healthcare providers. This informal approach creates significant safety concerns, as doses may substantially exceed the approximately 250 milligrams per day used in clinical trials. The source and quality of saffron products used traditionally are typically unverified, raising additional concerns about bioactive content variability and potential contamination. It is important to consistently distinguish between culinary saffron use, which involves only trace pinch quantities used to flavor and color food, and medicinal use, which employs concentrated doses in the range of 250 milligrams or higher. Patients often conflate these two contexts, leading to a false assumption that because culinary saffron is safe, higher medicinal doses carry equivalent risk. Healthcare providers should explicitly address this distinction when counseling patients.

Geographic variations in use patterns are notable. Saffron use during pregnancy is most prevalent in saffron-producing regions including Iran, Kashmir, Morocco, and parts of Greece and Afghanistan.^31,29 Cultural transmission occurs primarily through maternal lines, with mothers and mothers-in-law playing key roles in perpetuating traditional practices.

Theme 2: Cultural and Traditional Beliefs Surrounding Saffron

The majority of studies underscore that saffron use in pregnancy is fairly common in traditional beliefs and various cultures. Findings highlight that traditional Persian medicine and Ayurveda commonly use saffron for the purpose of lowering labor pain, enhancing delivery, and improving fetal complexion.^26,33

In addition to these cultural belief systems, historical literature is often referred to when saffron for childbirth is prescribed, especially by famous physicians like Avicenna and Rhazes. An ethnobotanical survey conducted in Morocco confirmed the grounds of these practices, where saffron is considered an agent that “eases childbirth” via reducing stress and anxiety.²⁹

One of the common cultural beliefs corresponds to its consumption being good for fetal growth and development as well as improving maternal strength during labor.²⁹ These ingrained cultural knowledge systems primarily enable the use of saffron via family and community pressure instead of consulting healthcare providers.

It is also corroborated in the study by Alsous and colleagues (2021), who reported that the popularity of herbal remedies, particularly among pregnant women, is attributed to their ingrained belief that herbal agents “have fewer side effects” in comparison to traditional therapeutic regimens. This signifies a widespread critical gap in knowledge.³⁴

Theme 3: Perceived Benefits and Risks of Saffron During Pregnancy and Childbirth

3.1 Potential Benefits

Most studies reported that saffron positively influences childbirth. Clinical trials demonstrated that saffron consumption leads to statistically significant improvements, such as enhanced cervical ripening in late pregnancy.^27,32 Majority of the randomized controlled trials agreed that saffron possesses the ability to minimize labor pain and its duration. What is striking here is that it could influence these effects in both primary and secondary stages of the process of childbirth.^26,36

Studies also confirmed saffron's improved properties like its uterotonic ability which ultimately enables improved uterine contractions resulting in more efficient labor.²⁸ Clinical trials also highlighted limited medical intervention required in patients of saffron regimen group as they showed significantly lower levels of oxytocin use.²⁷ Collectively these findings highlight saffron's promising potential in improving the overall labor and childbirth process.

Another consistent finding was saffron's positive impact on the subjective childbirth experience. Women in the saffron groups self-reported greater efficacy in managing their labor compared to those in the placebo groups.²⁶ Studies also reported effective saffron-induced anxiolytic properties which are beneficial in minimizing labor-related anxiety and effectively breaking the fear-tension-pain cycle, a hallmark of childbirth.^26,36

Pharmacological Mechanisms

The analgesic and anxiolytic effects of saffron appear to involve multiple pharmacological pathways. Preclinical studies demonstrate that crocin, saffron's primary bioactive constituent, exerts naloxone-reversible antinociceptive effects in animal models, suggesting opioid receptor-mediated mechanisms of pain modulation.³⁷ The administration of crocin in rodent pain models produces dose-dependent analgesia that is significantly attenuated by naloxone pretreatment, indicating involvement of mu-opioid receptors.³⁷

Additionally, saffron constituents including crocin and safranal modulate neurotransmitter systems, particularly serotonergic pathways, which may account for the observed anxiolytic effects during labor. Studies demonstrate that saffron extract inhibits serotonin reuptake and modulates serotonin receptor activity, mechanisms similar to selective serotonin reuptake inhibitor medications.³⁸ This serotonergic modulation may explain the mood-stabilizing and anxiety-reducing effects reported in clinical trials.

The smooth muscle-relaxant properties attributed to saffron may involve effects on calcium channel activity and intracellular calcium regulation. In vitro studies suggest that saffron constituents modulate calcium influx in smooth muscle cells, potentially facilitating coordinated uterine contractions rather than increasing contractile force indiscriminately.³⁹ This mechanism could explain the paradoxical observation that saffron may both facilitate labor progression at controlled doses while causing pathological uterine stimulation at excessive doses.

Bioavailability and Pharmacokinetic Considerations

Limited data exist on saffron bioavailability in pregnant populations. Studies in non-pregnant adults suggest that crocin undergoes extensive first-pass metabolism, with peak plasma concentrations occurring 2 to 3 h after oral administration.⁴⁰ The absolute bioavailability of crocin is estimated at approximately 0.04 to 2.4%, depending on formulation, co-administered food, and individual variability in intestinal and hepatic metabolism.⁴⁰

Safranal, being more lipophilic than crocin, demonstrates better membrane permeability and bioavailability but is also subject to rapid metabolism via cytochrome P450 enzymes.⁴¹ Both crocin and safranal are extensively metabolized, with metabolites excreted primarily in urine. The short half-lives of these compounds (approximately 4 to 6 h) necessitate multiple daily dosing to maintain therapeutic plasma concentrations.

These pharmacokinetic characteristics raise important questions about optimal dosing strategies during pregnancy. Physiological changes during pregnancy, including increased glomerular filtration rate, expanded plasma volume, altered hepatic enzyme activity, and changes in gastrointestinal motility and pH, substantially affect drug absorption, distribution, metabolism, and elimination.⁴² No studies have characterized saffron pharmacokinetics across trimesters or assessed whether maternal plasma concentrations correlate with clinical effects or fetal exposure.

Critically, placental transfer of saffron constituents remains uncharacterized. The lipophilic nature of safranal suggests potential for placental passage, while the hydrophilic crocin may have limited transfer. However, without direct measurement of fetal plasma or amniotic fluid concentrations, fetal exposure cannot be accurately estimated. This represents a significant knowledge gap given concerns about potential teratogenic or neurodevelopmental effects.

3.2 Dose-Dependent Safety Profile and Associated Risks

This integrative review highlights another duality noted in saffron's safety profile, its dose dependency. Within clinical trials, low dosage of saffron (approximately 250 to 750 milligrams at term) showed no incident of negative maternal or neonatal outcome, which significantly translates into its enhanced tolerance in controlled clinical settings, particularly for low-risk, term pregnancies.^26,32

These findings were notably contradicted across studies, which reported that saffron's consumption in higher dosages or being occupationally exposed in saffron fields increases critical pregnancy-associated risks. Studies focused on women farmers in saffron fields noted elevated risk for miscarriage, particularly due to longer dermal or inhalational exposure.³¹

This heightened risk due to increased saffron consumption is also confirmed through studies conducted on animal models or pharmacological reviews, which highlight saffron's abortifacient and uterotonic tendencies, which might result in uterine spasms, preterm labor, and fetal resorption.^28,30 Collectively, these findings raise concern regarding the use of saffron during the first trimester while also highlighting that its potential safety is mostly associated with its consumption in precise and smaller amounts at term.

Theme 4: Gaps in Evidence and Clinical Practice Implications

Findings also highlight critical gaps in the clinical implications of saffron. Despite its proven potential, its clinical validation is limited in the context of no standardization of dosage or formulation, lack of long-term efficacy data, and no proven effects of saffron on the health of neonates. Additionally, studies do not provide an agreeable optimum for possible timing, duration of administration, or even its compatibility with women who are already presented with other obstetric challenges.²⁰

Regarding self-medication, a critical finding was that pregnant women often relied on “knowledge from previous experience” rather than consulting pharmacists or physicians. This highlights a severe communication gap in prenatal care.

While efforts are being carried out to overcome this gap, studies emphasize that midwives and obstetricians adopt a more open and non-judgmental counseling approach. Similarly, it is also imperative for clinicians to have a more proactive strategy including asking questions about patient's herbal use, give respect to their cultural knowledge system, while simultaneously providing them awareness and educating them on the severity associated with not having adequate knowledge about dosage, administration timings which might lead to critical life-threatening outcomes such as abortion.^31,34

Discussion

This integrative review provides the first comprehensive synthesis integrating clinical evidence, cultural practices, and safety data on saffron use during pregnancy and childbirth.

Use of Saffron During Pregnancy: Integration of Clinical and Cultural Practices

The findings reveal distinct patterns of saffron use across clinical and traditional contexts. Clinical trials employ standardized preparations, precise dosing (approximately 250 milligrams per day), and specific timing (typically at term, 37 to 40 weeks gestation), with documented oversight and monitoring.^26,27,32 In contrast, traditional use is characterized by variable preparations, unstandardized dosing, earlier initiation (often from mid-pregnancy), and reliance on informal knowledge transmission rather than healthcare provider guidance.

This divergence creates a significant clinical challenge. The safety and efficacy data generated in controlled trial settings may not translate directly to real-world traditional use, where dosing is imprecise, product quality is unverified, and use often begins earlier in pregnancy when the developing fetus may be more vulnerable to potential teratogenic effects. Healthcare providers must recognize this gap when counseling patients who choose to use saffron based on cultural practices.

Cultural Beliefs and Their Influence on Saffron use

One of the noteworthy findings of this review is that the utilization of saffron is deeply rooted primarily within cultural beliefs, which sometimes are favored more than the evidence-based scientific recommendations. For example, beliefs associated with the use of saffron, such as for a fair-skinned baby or fetal strength, are widespread and somewhat compelling.

These findings mirror the phenomenon of “cultural consonance,” which encompasses the overarching belief in shared cultural practices, and the outcome is always considered to be resulting in improved health.³⁹ These ingrained beliefs can impair patient-provider communication.

To avoid judgment, pregnant women often conceal their use of herbal medicines, a practice commonly documented in studies of complementary medicine in prenatal care.⁴⁰ Miscommunications like these restrict healthcare providers from assessing the degree of complication effectively, and patients often cannot assess the severity of safety information due to a lack of awareness, which ultimately results in life-threatening complications as described by Ajam and colleagues (2014).³¹

Perceived Benefits and Risks of Saffron During Pregnancy and Childbirth

Evidence for Potential Benefits

The findings highlighted a critical aspect of saffron: its dose-dependent nature. This was verified as many randomized controlled trials reported a minimum dosage (approximately 250 to 750 milligrams) during the clinical trials which demonstrated improved benefits in cervical ripening, labor analgesia, and anxiolysis.^26,27

This corresponds to a collective mechanistic foundation for preclinical trials, such as its potential for being an analgesic might be attributed to its ability in modulating the opioid system. This claim is supported in a study conducted in animal models that illustrated saffron's capacity to be analgesic due to its primary constituent crocin, as they were naloxone-reversible, the study reported its potential role in opioid receptor-mediated pathway.³⁷

These findings reflect increased scientific evidence for another potential benefit of saffron during pregnancy, minimizing labor pain. Our findings also revealed the anxiolytic effect of saffron, which is highly supported in the constantly evolving literature on the management of anxiety and depression by utilizing saffron. It is backed up by evidence that saffron has the tendency to modulate neurotransmitters, specifically, serotonin.³⁸

Dose-Dependent Safety Profile and Associated Risks

Despite these promising findings and supporting evidence, saffron's efficacy is contrasted by its increased risk due to high dosages or occupational exposure, which also aligns with the findings from historical knowledge systems that reported its status as an abortifacient.

This contradictory nature of saffron reflects a critical healthcare implication that underscores that there is a very fine line between therapeutic dose and its associated toxicity, which is often overlooked, particularly when it comes to cultural belief systems.

Gaps in Clinical Practice and Research Implications

Findings uncovered a number of gaps within clinical choices. One of the major challenges is the lack of validation in the form of pharmacokinetic or safety data for saffron's consumption during pregnancy. Randomized controlled trials conducted with this focus do promise potential, but it is particularly restricted to controlled or low dosages, while females with risky pregnancies are often excluded from these trials.

Similarly, there is also a scarcity of literature identified, especially when it comes to long-term neurodevelopmental results in neonates who were exposed to saffron while still in utero. Another critical challenge lies within the lack of standardization as studies widely report that bioactive compound of saffron, such as crocin or safranal, has drastically variable results depending on geographical origin, storage conditions, and their processing.⁴¹

This means a “250 milligram dose” of a particular saffron product may vary significantly in its pharmacological impact from another, emphasizing its increased risk associated with not having a universally acceptable dosage. There is also limited literature focusing on herb-drug interaction, for instance, there is abundance of studies reporting saffron's impact on improving mood whereas the possible risk of administering saffron in conjunction with antidepressants or anxiolytics during pregnancy is rarely discussed while it creates a possible risk scenario.

Several clinical implications were also reported particularly in the context of clinical practice and saffron consumption during pregnancy. It is of critical importance for healthcare providers to be flexible, non-judgmental and welcoming of patient's cultural beliefs associated with the use of herbal medicines. Obstetricians and midwives, they are more likely to face pregnant women should approach more open communication strategy where patient freely disclose their cultural attachment to using herbal alternatives and are respected by clinicians. This strategy will help overcome the communication barrier persisting. It simultaneously allows the opportunity to educate them about potential risks of using herbal medicines that are not approved by their healthcare provider and come to a mutual consensus.

Study Limitations

This review faces several important limitations that warrant acknowledgment. The relatively small number of included studies (12 studies) and substantial heterogeneity in study design, saffron dosage, formulation, timing of administration, and outcome measures limit the ability to draw definitive conclusions. Sample sizes in clinical trials were generally small, with most trials excluding high-risk pregnancies, limiting generalizability.

Important methodological limitations must be acknowledged. This integrative review did not employ formal risk-of-bias assessment tools or certainty-of-evidence grading systems such as Grading of Recommendations Assessment, Development and Evaluation (GRADE). This omission, while common in integrative reviews synthesizing diverse study types, limits the ability to assess the overall quality of evidence rigorously. Readers should interpret findings with appropriate caution, recognizing that included studies varied substantially in methodological rigor.

Particularly concerning is the paucity of data on neonatal outcomes and long-term developmental effects of fetal saffron exposure. While short-term neonatal assessments in included trials showed no apparent harm, comprehensive neurodevelopmental follow-up data are absent. This represents a critical gap given the vulnerability of the developing fetal nervous system and the potential for subtle effects that may only manifest later in childhood development.

Additionally, the review included only English-language publications, potentially excluding relevant studies from regions where saffron use is most prevalent, particularly Persian-language and Arabic-language literature from Iran and Middle Eastern countries where saffron has deep historical roots. Publication bias toward positive findings may overestimate benefits while underestimating risks. The absence of standardized saffron preparations across studies makes dose comparisons approximate at best, with bioactive content likely varying substantially between products used in different trials.

Conclusion

This integrative review provides the first comprehensive synthesis integrating clinical evidence, cultural practices, and safety data on saffron use during pregnancy and childbirth. The findings reveal a complex landscape where promising clinical potential at controlled low doses contrasts sharply with significant risks associated with unmonitored or excessive consumption.

Low-dose saffron, typically approximately 250 milligrams per day administered at term, demonstrates potential benefits for cervical ripening, labor pain reduction, anxiety management, and shortened labor duration in clinical trial settings. These effects appear mechanistically plausible given saffron's documented analgesic, anxiolytic, and smooth muscle-modulating properties. The integration of clinical findings with traditional use patterns validates certain aspects of cultural knowledge while highlighting the critical importance of dose control.

However, the dose-dependent safety profile presents substantial clinical challenges. The same herb that shows promise at controlled doses can cause uterine stimulation, miscarriage, and other serious adverse effects when consumed excessively or through occupational exposure. This duality underscores the inadequacy of blanket recommendations either endorsing or prohibiting saffron use during pregnancy.

Saffron use is deeply embedded in cultural belief systems, particularly in South Asian and Middle Eastern communities, where it represents centuries of traditional knowledge. Healthcare providers must navigate this cultural significance while ensuring patient safety. A dismissive approach risks alienating patients and driving underground use, while uncritical acceptance ignores legitimate safety concerns.

Ultimately, evidence-based clinical guidance requires substantial additional research. Standardized saffron preparations with verified bioactive content, established dosing protocols across pregnancy trimesters, comprehensive pharmacokinetic studies in pregnant populations, long-term maternal and neonatal outcome data, and herb-drug interaction assessments are all critically needed before definitive clinical recommendations can be made.

In the interim, healthcare providers should adopt a culturally sensitive, individualized counseling approach. This involves openly discussing saffron use, explaining the dose-dependent nature of both benefits and risks, emphasizing the dangers of uncontrolled consumption, and collaboratively developing safe use plans when patients choose to continue use based on cultural practices. This balanced approach respects cultural autonomy while prioritizing maternal and fetal safety.

Clinical Implications for Healthcare Providers

Healthcare providers should implement the following evidence-based counseling approach when encountering pregnant women who use or are considering using saffron:

Routine Assessment

Include questions about herbal medicine use, specifically saffron, in standard prenatal intake procedures. Create a non-judgmental environment that encourages disclosure by framing questions as routine information gathering rather than interrogation. Recognize that many women will not volunteer information about herbal use unless specifically and directly asked, often due to fear of judgment or assumptions that herbal products do not constitute “real medicine” requiring disclosure.

Risk Stratification

Assess current saffron use comprehensively: dose, frequency, duration, formulation, source, and reason for use. Identify high-risk scenarios including first trimester use (highest miscarriage risk), high doses (exceeding 250 milligrams per day), unverified products from non-pharmaceutical sources, and occupational exposure through farming or processing activities. Consider trimester-specific risks, with miscarriage risk highest in the first trimester and unknown teratogenic potential throughout pregnancy.

Individualized Counseling

Acknowledge and respect the cultural significance of saffron use. Explain the dose-dependent nature clearly: potential benefits at approximately 250 milligrams per day at term (37 to 40 weeks) versus serious risks including miscarriage, abnormal uterine contractions, and potential fetal effects at higher doses or earlier in pregnancy. Emphasize the lack of safety data for first and second trimesters and the potential risks during these vulnerable periods of fetal development. Discuss alternative evidence-based pain management strategies including epidural analgesia, intravenous opioids, nitrous oxide, and non-pharmacological methods such as continuous labor support, hydrotherapy, and movement.

Shared Decision-Making

For women determined to continue saffron use despite counseling, recommend: delaying use until 37 to 40 weeks gestation (term), using only verified pharmaceutical-grade products with documented bioactive content, measuring dose precisely (maximum 250 milligrams per day), and avoiding use completely if high-risk pregnancy including preterm labor history, placental abnormalities, hypertensive disorders, or multiple gestation. Document all discussions, patient decisions, and counseling provided thoroughly in the medical record. Establish a follow-up monitoring plan with clear parameters for discontinuation if complications arise.

Special Populations

Women with occupational exposure (saffron farmers, processors, packagers): strongly recommend pregnancy leave or role modification to eliminate exposure, as studies document substantially elevated miscarriage risk with occupational inhalational and dermal exposure.³¹ Women using saffron for mood or anxiety symptoms: discuss safer alternatives including counseling, cognitive-behavioral therapy, and pregnancy-compatible medications if clinically indicated after psychiatric consultation. High-risk pregnancies (preterm labor history, placental abnormalities, hypertensive disorders, multiple gestation, fetal growth restriction): strongly advise against any saffron use given theoretical risks of uterine stimulation and lack of safety data in these vulnerable populations.

Practical Considerations

Even if firm evidence-based recommendations cannot yet be made due to limited research, these structured counseling strategies provide a framework for addressing saffron use in clinical practice. The approach respects cultural practices and traditional knowledge while ensuring informed decision-making based on available evidence. Healthcare providers should remain current with emerging research in this rapidly evolving field and adjust counseling as new evidence becomes available.

Recommendations for Practice and Policy

Based on the findings of this integrative review, the following recommendations are proposed:

Practice Recommendations

For Healthcare Providers

Routinely inquire about herbal medicine use, including saffron, during prenatal care intake and at each prenatal visit, using non-judgmental language that encourages honest disclosure. Provide culturally sensitive, evidence-based counseling on potential risks and benefits, acknowledging the cultural significance of traditional practices while presenting current scientific evidence. Strongly advise against saffron use during first and second trimesters due to insufficient safety data and documented miscarriage risks with higher doses or occupational exposure. If patients choose to use saffron at term (37 to 40 weeks gestation), recommend verified pharmaceutical-grade products, precise dosing (maximum 250 milligrams per day), and close monitoring for signs of excessive uterine activity or fetal distress. Advise complete avoidance in high-risk pregnancies including those with preterm labor history, placental abnormalities, hypertensive disorders, or multiple gestation. Document all discussions about herbal medicine use, counseling provided, and patient decisions thoroughly in the medical record.

For Pregnant Women

Consult healthcare providers before using saffron or any herbal preparation during pregnancy, even if recommended by family members or traditional practitioners. Avoid self-prescribed high doses or products from unverified sources without pharmaceutical-grade quality control. Be aware of dose-dependent risks, particularly in early pregnancy when fetal organs are developing. Disclose all herbal medicine use to healthcare providers, understanding that this information is essential for safe pregnancy management.

For Traditional Birth Attendants and Community Health Workers

Provide education on safe use parameters, contraindications, and warning signs of complications related to saffron use. Establish clear referral pathways for high-risk cases requiring consultation with or transfer to formal healthcare facilities. Collaborate with formal healthcare systems to integrate traditional knowledge safely while ensuring evidence-based risk mitigation.

Policy Recommendations

Regulatory Oversight

Establish quality control standards for saffron products marketed for pregnancy use, including verification of bioactive content (crocin, safranal) and absence of contaminants. Require clear labeling of bioactive content per dose and pregnancy-specific warnings on all saffron products, similar to pharmaceutical medications. Mandate reporting of adverse events related to saffron use in pregnancy to national pharmacovigilance systems to improve post-market surveillance.

Healthcare System Integration

Include comprehensive herbal medicine education in midwifery and obstetric training curricula, covering common herbs used in pregnancy including saffron, with emphasis on cultural competency and evidence-based counseling. Develop culturally appropriate patient education materials about saffron safety in multiple languages commonly spoken in communities with high traditional saffron use. Create clinical practice guidelines for counseling on herbal medicine in pregnancy, providing healthcare providers with standardized evidence-based approaches.

Research Funding Priorities

Support large-scale, well-designed randomized controlled trials with standardized pharmaceutical-grade saffron preparations, adequate sample sizes, and comprehensive outcome assessment. Fund long-term prospective cohort studies following children exposed to saffron in utero through key developmental milestones to assess neurodevelopmental outcomes. Prioritize pharmacokinetic studies in pregnant populations across all trimesters, including assessment of placental transfer and fetal exposure. Support ethnopharmacological research integrating traditional knowledge with modern scientific methods, conducted in partnership with communities practicing traditional medicine.

Areas for Future Research

This review identifies several critical areas requiring further investigation:

Standardization and Dosing Studies

Development of pharmaceutical-grade saffron preparations with verified and standardized bioactive content (crocin, safranal, and other constituents) suitable for clinical use. Dose-ranging studies to establish optimal therapeutic dosing at term, including assessment of dose-response relationships for efficacy outcomes (cervical ripening, pain reduction, labor duration) and safety outcomes. Comparative effectiveness trials of different saffron formulations (aqueous extracts, ethanolic extracts, stigma powder) to determine which preparation provides optimal bioavailability and clinical effects. Trimester-specific safety and efficacy assessments, with particular emphasis on first trimester exposure and associated risks. Critically, the concentration of active metabolites such as crocin and safranal can vary substantially depending on the geographic origin of the stigmas, harvesting methods, drying processes, and storage conditions. This variability means that a nominally identical “250 milligram dose” across different studies may represent markedly different pharmacological exposures, making cross-study comparisons unreliable. Future clinical trials must therefore prioritize the use of standardized, characterized saffron preparations with documented and verified bioactive content as a prerequisite for meaningful evidence synthesis.

Pharmacokinetic and Pharmacodynamic Research

Comprehensive pharmacokinetic studies in pregnant women across all trimesters, characterizing absorption, distribution, metabolism, and elimination of major saffron constituents. Investigation of placental transfer of crocin, safranal, and other bioactive compounds, including measurement of maternal and fetal plasma concentrations and assessment of placental barrier function. Relationship between maternal plasma concentrations and clinical effects, establishing therapeutic concentration ranges if possible. Characterization of physiological changes in pregnancy affecting saffron metabolism and clearance, including alterations in cytochrome P450 enzyme activity, plasma protein binding, and renal clearance. Identification of genetic polymorphisms affecting saffron metabolism, which may explain inter-individual variability in response and risk.

Long-Term Maternal and Neonatal Outcomes

Prospective cohort studies following children exposed to saffron in utero from birth through school age, with standardized assessment protocols and adequate sample sizes to detect subtle effects. Comprehensive neurodevelopmental assessments at key developmental milestones (6 months, 12 months, 18 months, 3 years, 5 years), including standardized cognitive, motor, language, and behavioral evaluations. Evaluation of long-term maternal outcomes including postpartum hemorrhage, mood disorders, lactation success, and subsequent pregnancy outcomes. Assessment of breastfeeding safety, including measurement of saffron constituent transfer into breast milk and calculation of infant exposure through lactation.

Mechanistic Studies

Elucidation of molecular mechanisms underlying analgesic effects, including detailed characterization of opioid receptor interactions, endogenous opioid system modulation, and non-opioid pain pathways. Investigation of smooth muscle effects and uterine contractility modulation, using ex vivo uterine tissue preparations and in vivo animal models to understand how saffron constituents affect myometrial activity. Characterization of anxiolytic pathway mechanisms, including serotonin receptor binding studies, monoamine oxidase inhibition assessments, and gamma-aminobutyric acid system interactions. Assessment of potential teratogenic mechanisms at high doses, including oxidative stress induction, apoptosis pathway activation, and developmental signaling pathway disruption in relevant animal models.

Safety and Interaction Studies

Establishment of comprehensive adverse event registries for herbal medicine use in pregnancy, enabling systematic collection and analysis of safety data across large populations. Herb-drug interaction studies with common pregnancy medications including prenatal vitamins, iron supplements, antacids, antiemetics, antihypertensives, and tocolytics, using both in vitro and clinical approaches. Identification of patient populations at increased risk of adverse effects based on genetic factors, pre-existing medical conditions, or concurrent medication use. Investigation of potential cumulative effects with other herbal preparations commonly used concurrently with saffron, such as ginger, chamomile, or raspberry leaf.

Cultural and Implementation Research

Mixed-methods studies examining decision-making processes around saffron use in diverse cultural contexts, exploring motivations, information sources, risk perceptions, and barriers to healthcare provider communication. Development and testing of culturally tailored counseling interventions, using community-based participatory research methods to ensure cultural appropriateness and acceptability. Implementation science research on integrating traditional practices with evidence-based care, identifying facilitators and barriers at patient, provider, and health system levels. Health services research on barriers and facilitators to disclosure of herbal use, including investigation of patient concerns, provider attitudes, and effective communication strategies.

Comparative Effectiveness Research

Head-to-head randomized trials comparing saffron with standard pharmacological labor pain management including epidural analgesia, intravenous opioids, and nitrous oxide, assessing both efficacy and safety outcomes. Cost-effectiveness analyses in different healthcare settings, considering medication costs, healthcare utilization, maternal satisfaction, and health outcomes. Patient preference studies and quality of life assessments, including willingness-to-pay analyses and discrete choice experiments. Comparative safety profiles with other commonly used herbal preparations during pregnancy such as ginger (for nausea), raspberry leaf (for labor preparation), and chamomile (for anxiety).

These research priorities, if addressed systematically through well-designed, adequately powered studies, would provide the evidence base necessary for developing robust clinical practice guidelines and enabling truly informed decision-making by pregnant women and their healthcare providers. Funding agencies, research institutions, and pharmaceutical companies should prioritize these critical knowledge gaps in maternal and neonatal health.

Supplemental Material

sj-docx-1-chp-10.1177_2515690X261455162 - Supplemental material for Saffron and Pregnancy: Cultural Practices, Beliefs, and Safety Evidence: An Integrative Review

Supplemental material, sj-docx-1-chp-10.1177_2515690X261455162 for Saffron and Pregnancy: Cultural Practices, Beliefs, and Safety Evidence: An Integrative Review by Aisha Alshdefat, Ahmad Ayed, Ibrahim Aqtam, Olabisi Ibitoye, Sophia Vincent and Atiya Al Furqani in Journal of Evidence-Based Integrative Medicine

Footnotes

Acknowledgements

Not applicable.

ORCID iD

Ibrahim Aqtam

Ethics Approval and Consent to Participate

Not applicable. This study is an integrative review of previously published literature and did not involve direct contact with human or animal subjects. Therefore, ethical approval and consent were not required.

Consent for Publication

Not applicable.

Authors’ Contributions

A.A.: Conceptualization, Methodology, Investigation, Writing - Original Draft, Writing - Review & Editing. O.I.: Conceptualization, Methodology, Writing - Review & Editing, Supervision. S.V.: Investigation, Data Curation, Writing - Original Draft. A.A.F.: Investigation, Data Curation, Writing - Original Draft. I.A.: Formal analysis, Writing - Review & Editing. A.A.: Formal analysis, Writing - Review & Editing.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Availability of Data and Materials

All data generated or analyzed during this study are included in this published article. The datasets supporting the conclusions of this article are available from the corresponding author upon reasonable request.

Trial Registration

Not applicable.

Supplemental Material

Supplemental material for this article is available online.

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