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International Journal of Gynaecology... Jun 2015Building upon the World Health Organization's ExpandNet framework, 12 key principles of scale-up have emerged from the implementation of maternal and newborn health...
Building upon the World Health Organization's ExpandNet framework, 12 key principles of scale-up have emerged from the implementation of maternal and newborn health interventions. These principles are illustrated by three case studies of scale up of high-impact interventions: the Helping Babies Breathe initiative; pre-service midwifery education in Afghanistan; and advanced distribution of misoprostol for self-administration at home births to prevent postpartum hemorrhage. Program planners who seek to scale a maternal and/or newborn health intervention must ensure that: the necessary evidence and mechanisms for local ownership for the intervention are well-established; the intervention is as simple and cost-effective as possible; and the implementers and beneficiaries of the intervention are working in tandem to build institutional capacity at all levels and in consideration of all perspectives.
Topics: Afghanistan; Female; Home Childbirth; Humans; Infant, Newborn; Midwifery; Misoprostol; Oxytocics; Postpartum Hemorrhage; Practice Guidelines as Topic; Pregnancy; Self Administration; World Health Organization
PubMed: 26115856
DOI: 10.1016/j.ijgo.2015.03.010 -
The Cochrane Database of Systematic... Aug 2018In most Western countries, obstetricians and midwives induce labour in about 25% of pregnant women. Oxytocin is an effective drug for this purpose, but associated with... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In most Western countries, obstetricians and midwives induce labour in about 25% of pregnant women. Oxytocin is an effective drug for this purpose, but associated with serious adverse effects of which uterine tachysystole, fetal distress and the need for immediate delivery are the most common. Various administration regimens such as reduced or pulsatile dosing have been suggested to minimise these. Discontinuation in the active phase of labour, i.e. when contractions are well-established and the cervix is dilated at least 5 cm is another method which may reduce adverse effects.
OBJECTIVES
To assess whether birth outcomes can be improved by discontinuation of intravenous (IV) oxytocin, initiated in the latent phase of induced labour, once active phase of labour is established.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2018), Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) (23 January 2018) together with reference checking, citation searching, and contact with study authors to identify additional studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing discontinued IV with continuous IV oxytocin in the active phase of induced labour.No exclusion criteria were applied in terms of parity, maternal age, ethnicity, co-morbidity status, labour setting, gestational age, and prior caesarean delivery.Studies comparing different dosage regimens are outside the scope of this review.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods.
MAIN RESULTS
We found 10 completed RCTs involving 1888 women. One additional trial is ongoing. The included trials were conducted in hospital settings between February 1998 and January 2016, two in Europe (Denmark, and Greece), two in Turkey, and one each in Israel, Iran, USA, Bangladesh, India, and Thailand. Most trials included full-term singleton pregnancies with a fetus in vertex presentation. Some excluded women with cervical priming prior to induction and some excluded women with a history of prior caesarean delivery. When reported, the average age of the women ranged from 22 to 31 years, nulliparity from 45% to 68%, and pre-pregnancy body mass index from 22 to 32.Many of the included trials had design limitations and were judged to be at either high or unclear risk of bias across a number of 'Risk of bias' domains.Four trials included a Consort flow diagram. In three, this gave details of participants delivered before the active phase of labour, and treatment compliance for those who reached that stage. One Consort diagram only provided the latter information. The data in many of the trials without such a flow diagram were implausibly compliant with treatment allocation, suggesting that there had been silent post randomisation exclusions of women delivered before the active phase of labour. We therefore conducted a secondary analysis (not in our protocol) of caesarean section among women who reached the active phase of labour and were therefore eligible for the intervention.Our analysis by 'intention-to-treat' found that, compared with continuation of IV oxytocin stimulation, discontinuation of IV oxytocin may reduce the caesarean delivery rate, risk ratio (RR) 0.69, 95% confidence interval (CI) 0.56 to 0.86, 9 trials, 1784 women, low-level certainty. However, restricting our analysis to women who reached the active phase of labour (using 'reached active phase' as our denominator) suggests there is probably little or no difference between groups (RR 0.92, 95% CI 0.65 to 1.29, 4 trials, 787 women, moderate-certainty evidence).Discontinuation of IV oxytocin probably reduces the risk ofuterine tachysystole combined with abnormal fetal heart rate (FHR) compared with continued IV oxytocin (RR 0.15, 95% CI 0.05 to 0.46, 3 trials, 486 women, moderate-level certainty). We are uncertain about whether or not discontinuation increases the risk of chorioamnionitis (average RR 2.32, 95% CI 0.99 to 5.45, 1 trial, 252 women, very low-level certainty). Discontinuation of IV oxytocin may have little or no impact on the use of analgesia and epidural during labour compared to the use of continued IV oxytocin (RR 1.04 95% CI 0.95 to 1.14, 3 trials, 556 women, low-level certainty). Intrapartum cardiotocography (CTG) abnormalities (suspicious/pathological CTGs) are probably reduced by discontinuing IV oxytocin (RR 0.65, 95% CI 0.51 to 0.83, 7 trials, 1390 women, moderate-level certainty). Compared to continuing IV oxytocin, discontinuing IV oxytocin probably has little or no impact on the incidence of Apgar < 7 at five minutes (RR 0.78, 95% CI 0.27 to 2.21, 4 trials, 893 women, low-level certainty), or and acidotic cord gasses at birth (arterial umbilical pH < 7.10), (RR 1.03, 95% CI 0.50 to 2.13, 4 trials, 873 women, low-level certainty).Many of this review's maternal and infant secondary outcomes (including maternal and neonatal mortality) were not reported in the included trials.
AUTHORS' CONCLUSIONS
Discontinuing IV oxytocin stimulation after the active phase of labour has been established may reduce caesarean delivery but the evidence for this was low certainty. When restricting our analysis to those trials that separately reported participants who reached the active phase of labour, our results showed there is probably little or no difference between groups. Discontinuing IV oxytocin may reduce uterine tachysystole combined with abnormal FHR.Most of the trials had 'Risk of bias' concerns which means that these results should be interpreted with caution. Our GRADE assessments ranged from very low certainty to moderate certainty. Downgrading decisions were based on study limitations, imprecision and indirectness.Future research could account for all women randomised and, in particular, note those who delivered before the point at which they would be eligible for the intervention (i.e. those who had caesareans in the latent phase), or because labour was so rapid that the infusion could not be stopped in time.Future trials could adopt the outcomes listed in this review including maternal and neonatal mortality, maternal satisfaction, and breastfeeding.
Topics: Administration, Intravenous; Adult; Cardiotocography; Cesarean Section; Chorioamnionitis; Female; Fetal Distress; Humans; Intention to Treat Analysis; Labor Stage, Third; Labor, Induced; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic; Withholding Treatment; Young Adult
PubMed: 30125998
DOI: 10.1002/14651858.CD012274.pub2 -
Drug Design, Development and Therapy 2015Induction of labor is one of the most commonly performed obstetric procedures and will likely become more common as the reproductive population in developed nations... (Review)
Review
Induction of labor is one of the most commonly performed obstetric procedures and will likely become more common as the reproductive population in developed nations changes. As the proportion of women undergoing induction grows, there is a constant search for more efficacious ways to induce labor while maintaining fetal and maternal safety as well as patient satisfaction. With almost half of induced labors requiring cervical ripening, methods for achieving active labor and vaginal delivery are constantly being investigated. Prostaglandins have been shown to be effective induction agents, and specifically vaginal misoprostol, used off-label, have been widely utilized to initiate cervical ripening and active labor. The challenge is to administer this medication accurately while maintaining the ability to discontinue the medication when needed. The misoprostol vaginal insert initiates cervical ripening utilizing a delivery system that controls medication release and can be rapidly removed. This paper reviews the design, development, and clinical utility of the misoprostol vaginal insert for induction of labor as well as patient considerations related to the delivery system.
Topics: Administration, Intravaginal; Adult; Cervical Ripening; Chemistry, Pharmaceutical; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Drug Delivery Systems; Drug Implants; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy
PubMed: 25960635
DOI: 10.2147/DDDT.S64227 -
Harvard Review of Psychiatry 2013After participating in this educational activity, the physician should be better able to 1. Identify the biological role of oxytocin in forming attachments. 2. Evaluate... (Review)
Review
After participating in this educational activity, the physician should be better able to 1. Identify the biological role of oxytocin in forming attachments. 2. Evaluate the relationship between various neuropsychiatric disorders and oxytocin. 3. Identify clinical implications of using oxytocin to treat various neuropsychiatric disorders. Oxytocin is a peptide hormone integral in parturition, milk letdown, and maternal behaviors that has been demonstrated in animal studies to be important in the formation of pair bonds and in social behaviors. This hormone is increasingly recognized as an important regulator of human social behaviors, including social decision making, evaluating and responding to social stimuli, mediating social interactions, and forming social memories. In addition, oxytocin is intricately involved in a broad array of neuropsychiatric functions and may be a common factor important in multiple psychiatric disorders such as autism, schizophrenia, and mood and anxiety disorders. This review article examines the extant literature on the evidence for oxytocin dysfunction in a variety of psychiatric disorders and highlights the need for further research to understand the complex role of the oxytocin system in psychiatric disease and thus pave the way for developing new therapeutic modalities. Articles were selected that involved human participants with various psychiatric disorders and that either compared oxytocin biology to healthy controls or examined the effects of exogenous oxytocin administration.
Topics: Emotional Intelligence; Epigenomics; Humans; Interpersonal Relations; Mental Disorders; Oxytocics; Oxytocin; Psychopathology; Psychotropic Drugs; Randomized Controlled Trials as Topic; Social Behavior
PubMed: 24651556
DOI: 10.1097/HRP.0b013e3182a75b7d -
Acta Obstetricia Et Gynecologica... Apr 2021The use of oxytocin to augment labor is increasing in many low-resource settings; however, little is known about the effects of such use in contexts where resources for...
INTRODUCTION
The use of oxytocin to augment labor is increasing in many low-resource settings; however, little is known about the effects of such use in contexts where resources for intrapartum monitoring are scarce. In this study, we sought to assess the association between augmentation of labor with oxytocin and delivery outcomes.
MATERIAL AND METHODS
We conducted a cohort study in 12 public hospitals in Nepal, including all deliveries with and without augmentation of labor with oxytocin, but excluding elective cesarean sections, women with missing information on augmentation of labor, and women without fetal heart rate on admission. Bivariate and multivariate logistic regression calculating the crude and adjusted risk ratio (aRR) with corresponding 95% CI were performed, comparing (a) intrapartum stillbirth and first-day mortality (primary outcome); and (b) intrapartum monitoring, mode of delivery, postpartum hemorrhage, bag-and-mask ventilation of the newborn, Apgar score, and neonatal death before discharge (secondary outcomes) among women with and without oxytocin-augmented labor.
RESULTS
The total cohort consisted of 78 931 women, of whom 28 915 (37%) had labor augmented with oxytocin and 50 016 (63%) did not have labor augmented with oxytocin. Women with augmentation of labor had no increased risk of intrapartum stillbirth and first-day mortality (aRR 1.24, 95% CI 0.65-2.4), but decreased risks of suboptimal partograph use (aRR 0.71, 95% CI 0.68-0.74), suboptimal fetal heart rate monitoring (aRR 0.50, 95% CI 0.48-0.53), and emergency cesarean section (aRR 0.62, 95% CI 0.59-0.66), and increased risks of bag-and-mask ventilation (aRR 2.1, 95% CI 1.8-2.5), Apgar score <7 at 5 minutes (aRR 1.65, 95% CI 1.49-1.86), and neonatal death (aRR 1.93, 95% CI 1.46-2.56).
CONCLUSIONS
Although augmentation of labor with oxytocin might be associated with beneficial effects, such as improved monitoring and a decreased risk of cesarean section, its use may lead to an increased risk of adverse perinatal outcomes. We urge for a cautious use of oxytocin to augment labor in low-resource contexts, and call for evidence-based guidelines on augmentation of labor in low-resource settings.
Topics: Adult; Female; Hospitals, Public; Humans; Infant, Newborn; Labor, Obstetric; Nepal; Oxytocics; Oxytocin; Pregnancy; Pregnancy Outcome
PubMed: 32426852
DOI: 10.1111/aogs.13919 -
The Cochrane Database of Systematic... Nov 2015Medications or mechanical dilators are often used to soften and dilate the cervix prior to surgical evacuation of the uterus for non-viable pregnancy, or miscarriage.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Medications or mechanical dilators are often used to soften and dilate the cervix prior to surgical evacuation of the uterus for non-viable pregnancy, or miscarriage. The majority of miscarriages occur in the first trimester. The aim of cervical ripening is to reduce the possibility of injury to the uterus and cervix and improve the surgical ease of the procedure. Cervical ripening agents can have adverse effects and it is uncertain as to whether these risks outweigh the benefits of their use.
OBJECTIVES
To systematically review the benefits and harms of using cervical ripening agents prior to surgical evacuation of non-viable pregnancy prior to 14 weeks' gestation.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2015) and reference lists of retrieved papers.
SELECTION CRITERIA
Randomised controlled trials (published in full-text form, or as abstracts only), which assessed the use of pharmacological or mechanical agents to ripen the cervix in women undergoing dilation and curettage or vacuum aspiration for non-viable pregnancy at less than 14 weeks' gestation were eligible for inclusion. Cluster-randomised controlled trials and trials using a cross-over design were not eligible for inclusion.Unpublished randomised controlled trials and quasi-randomised trials would have been eligible for inclusion but none were identified.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data were checked for accuracy.
MAIN RESULTS
We included nine trials with 469 women. A diverse set of medications and regimens were studied in these trials, making the comparisons available for meta-analysis limited. The comparisons draw data from six trials with 383 participants. All trials were relatively small and had several aspects of unclear risk of bias with few of this review's outcomes reported. Due to this, no data from three trials were able to be used despite them meeting inclusion criteria.We carried out four comparisons: isosorbide mononitrate or dinitrate compared with misoprostol; misoprostol compared with placebo; chemical dilation (use of medications) compared with mechanical dilation; and any cervical preparation compared with placebo.None of the included studies reported data on the review's primary outcome: cervical or uterine injury (perforation, laceration, creation of a false passage).No clear difference was shown between isosorbide compounds and misoprostol for the outcome need for manual cervical dilation (average risk ratio (RR) 0.76, 95% confidence interval (CI) 0.10 to 5.64; three trials, 150 women; Tau² = 2.11; I² = 69%), however the data were heterogenous. In terms of adverse effects, misoprostol was associated with more vomiting (RR 0.11, 95% CI 0.01 to 0.85; two trials, 120 women), however there were no clear differences between isosorbide compounds and misoprostol in relation to other reported adverse effects (headache, nausea or hypotension). The dosing regimens differed in terms of dose, number of administrations and route of administration in the different trials. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators in a single trial (65 women) that measured difficulty in cervical dilation, excessive bleeding and adverse effects.Misoprostol was shown to be more effective than placebo for cervical ripening (reduced need for manual cervical dilation) (RR 0.14, 95% CI 0.08 to 0.26; one trial, 120 women), and surgical time was reduced when misoprostol was used (mean difference (MD) -3.15, 95% CI -3.59 to -2.70; one trial, 120 women). However, compared to placebo, misoprostol, was associated with more abdominal pain (RR 29.00, 95% CI 1.77 to 475.35; one trial, 120 women), although no clear differences in the risk of other adverse effects (nausea, vomiting, headache or fever) were observed between groups.There was no clear differences between chemical dilation and mechanical dilators for the outcomes: difficulty in cervical dilation, excessive bleeding or adverse effects.Compared with placebo, any cervical preparation reduced the need for manual cervical dilatation (average RR 0.25, 95% CI 0.07 to 0.89; two trials, 168 women; Tau² = 0.67; I² = 81%), and reduced surgical time (MD -2.55, 95% CI -3.67 to -1.43, two trials, 168 women; Tau² = 0.63; I² = 96%).None of the included trials reported on the review's other secondary outcomes, including: injury to bladder or bowel, miscarriage/preterm birth in a subsequent pregnancy, analgesia use after administration of ripening agent but before surgery, or analgesia use after surgery.
AUTHORS' CONCLUSIONS
This review found no evidence to evaluate cervical ripening prior to first trimester surgical evacuation for miscarriage for reducing the rate of cervical or uterine injury, however, this may be because these outcomes are very rare. Cervical preparation was shown to reduce the need for manual cervical dilatation compared with placebo.Misoprostol and isosorbide mononitrate and dinitrate were similarly effective in ripening the cervix, however there was more vomiting with misoprostol. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators.The nine studies included in this review were small and the methodological quality of the trials was mixed, and for the most part, not well-described; thus any conclusions drawn from the data included in this review must be treated with caution. Consequently, large, high-quality trials are required to determine whether the benefits of this treatment outweigh the risks. Further research should be powered to assess the rate of cervical and uterine injury between interventions. Future research should also guide clinicians in deciding whether the benefits of reduced manual cervical dilatation outweigh the risks of adverse effects associated with these agents (nausea, vomiting, headache, fever, diarrhoea and pain). Women's satisfaction and outcomes of future pregnancies should also be assessed.
Topics: Abortion, Eugenic; Abortion, Spontaneous; Adult; Cervical Ripening; Dilatation; Female; Humans; Isosorbide Dinitrate; Labor Stage, First; Misoprostol; Oxytocics; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic
PubMed: 26559875
DOI: 10.1002/14651858.CD009954.pub2 -
Anesthesiology Jan 2013
Topics: Animals; Delivery, Obstetric; Female; Humans; Hypersensitivity; Oxytocics; Oxytocin; Pain; Parturition; Peripheral Nerve Injuries
PubMed: 23249926
DOI: 10.1097/ALN.0b013e318278cbfd -
Reproductive Sciences (Thousand Oaks,... Dec 2023This study compares the effectiveness and safety of oxytocin infusion against oral misoprostol for inducing labour in pregnant women with term prelabor membrane rupture.... (Randomized Controlled Trial)
Randomized Controlled Trial
This study compares the effectiveness and safety of oxytocin infusion against oral misoprostol for inducing labour in pregnant women with term prelabor membrane rupture. We randomized 173 pregnant women presenting with term prelabor rupture of membranes (PROM) at Ain Shams University Maternity Hospital into Group A (underwent induction of labor (IOL) by 25μg misoprostol oral tablet every 4 h, for maximum 5 doses) and an identical Group B: (underwent IOL by oxytocin infusion according to the hospital protocol). Our primary outcome was rate of vaginal delivery within 24 h, while the secondary outcomes included the time till active phase, induction to delivery interval, maternal pyrexia, nausea and vomiting, fetal distress, Apgar score, birth weight, and neonatal intensive care unit admission. Both groups showed high rates of vaginal delivery (82.4% & 87.1% for misoprostol group and oxytocin group respectively) with no significant difference between the two groups (p=0.394). However, patients induced by misoprostol took significantly less time to reach active phase with a shorter induction to delivery interval as compared to patients induced with oxytocin. This difference was clear in multiparous women, but not observed in primiparous women when subgroup analysis was done. No significant difference was found as regards other outcomes. Our study showed that both oral misoprostol and oxytocin are effective and safe for IOL in patients with PROM, with shorter induction-delivery interval in patients induced by oral misoprostol, an effect that is clear in multiparous but not primiparous women. TRIAL REGISTRATION: NCT05215873, on 31/01/2022, "retrospectively registered".
Topics: Infant, Newborn; Female; Pregnancy; Humans; Misoprostol; Oxytocin; Oxytocics; Pregnant Women; Fetal Membranes, Premature Rupture; Labor, Induced
PubMed: 37442883
DOI: 10.1007/s43032-023-01290-0 -
BMC Pregnancy and Childbirth Nov 2019Community distribution of misoprostol to pregnant women in advance of labor is one of the compelling strategies for preventing postpartum hemorrhage. Concerns have been... (Review)
Review
INTRODUCTION
Community distribution of misoprostol to pregnant women in advance of labor is one of the compelling strategies for preventing postpartum hemorrhage. Concerns have been reported that misoprostol distribution could reduce facility delivery or lead to misuse of the medication. This scoping review was conducted to synthesize the evidence on the effect of community-based misoprostol distribution on rates of facility delivery, and to assess the frequency of mothers taking distributed misoprostol before delivery, and any harmful outcomes of such misuse.
METHODS
We included peer-reviewed articles on misoprostol implementation from PubMed, Cochrane Review Library, Popline, and Google Scholars. Narrative synthesis was used to analyze and interpret the findings, in which quantitative and qualitative syntheses are integrated.
RESULTS
Three qualitative studies, seven observational studies, and four experimental or quasi-experimental studies were included in this study. All before-after household surveys reported increased delivery coverage after the intervention: ranging from 4 to 46 percentage points at the end of the intervention when compared to the baseline. The pooled analysis of experimental and quasi-experimental studies involving 7564 women from four studies revealed that there was no significant difference in rates of facility delivery among the misoprostol and control groups [OR 1.011; 95% CI: 0.906-1.129]. A qualitative study among health professionals also indicated that community distribution of misoprostol for the prevention of postpartum hemorrhage is acceptable to community members and stakeholders and it is a feasible interim solution until access to facility birth increases. In the community-based distribution of misoprostol programs, self-administration of misoprostol by pregnant women before delivery was reported in less than 2% of women, among seven studies involving 11,108 mothers. Evidence also shows that most women who used misoprostol pills, used them as instructed. No adverse outcomes from misuse in either of the studies reviewed.
CONCLUSIONS
The claim that community-based distribution of misoprostol would divert women who would have otherwise had institutional deliveries to have home deliveries and promote misuse of the medication are not supported with evidence. Therefore, community-based distribution of misoprostol can be an appropriate strategy for reducing maternal deaths which occur due to postpartum hemorrhages, especially in resource-limited settings.
Topics: Delivery of Health Care; Female; Global Health; Humans; Incidence; Labor, Obstetric; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Risk Factors; Survival Rate
PubMed: 31694580
DOI: 10.1186/s12884-019-2539-5 -
Nursing Open Sep 2021To develop and validate the nomogram for risk estimation of Caesarean delivery and to compare the effect of cervical ripening balloon, evening primrose oil (EPO) and...
Developing and validating the Caesarean risk assessment nomogram and comparing the effect of cervical ripening balloon, evening primrose oil and misoprostol on childbirth outcomes in term pregnancies: A study protocol.
AIM
To develop and validate the nomogram for risk estimation of Caesarean delivery and to compare the effect of cervical ripening balloon, evening primrose oil (EPO) and misoprostol on Bishop Score and duration of the first stage of labour.
DESIGN
The first phase is a prospective study, and the second phase is a randomized controlled trial.
METHODS
In the first phase, the nomogram will be developed and validated over 300 participants, and in the second phase, the 90 participants will be allocated to three groups: vaginal 25mcg misoprostol, vaginal 4000mg EPO and double-balloon catheter, through block randomization method. The Bishop score will be evaluated every 4 hr, and if required the same dose will be repeated. Maximum waiting time for balloon is 12 hr if not effective, the catheter will be removed, and other interventions will be done according to guidelines.
DISCUSSION
The nomogram will help informed decision-making for women undergoing an induction with an unfavourable cervix and introducing effective low-complication methods of labour induction can improve the pregnancy outcomes.
Topics: Cervical Ripening; Cesarean Section; Female; Humans; Labor, Induced; Linoleic Acids; Misoprostol; Nomograms; Oenothera biennis; Oxytocics; Plant Oils; Pregnancy; Prospective Studies; Randomized Controlled Trials as Topic; Risk Assessment; gamma-Linolenic Acid
PubMed: 33689238
DOI: 10.1002/nop2.846