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International Journal of Environmental... Sep 2022Complications after abortion are a major cause of maternal death. Incomplete abortions are common and require treatment with surgical or medical uterine evacuation. Even...
Complications after abortion are a major cause of maternal death. Incomplete abortions are common and require treatment with surgical or medical uterine evacuation. Even though misoprostol is a cheaper and safer option, it is rarely used in Malawi. To improve services, an intervention was performed to increase the use of misoprostol in post-abortion care. This study explored healthcare providers' perceptions and experiences with misoprostol in the Malawian setting and their role in achieving effective implementation of the drug. A descriptive phenomenological study was conducted in three hospitals in central Malawi. Focus group discussions were conducted with healthcare workers in centres where the training intervention was offered. Participants were purposefully sampled, and thematic analysis was done. Most of the healthcare workers were positive about the use of misoprostol, knew how to use it and were confident in doing so. The staff preferred misoprostol to surgical treatment because it was perceived safe, effective, easy to use, cost-effective, had few complications, decreased hospital congestion, reduced workload, and saved time. Additionally, misoprostol was administered by nurses/midwives, and not just physicians, thus enhancing task-shifting. The results showed acceptability of misoprostol in post-abortion care among healthcare workers in central Malawi, and further implementation of the drug is recommended.
Topics: Abortion, Incomplete; Abortion, Induced; Female; Health Personnel; Humans; Malawi; Misoprostol; Pregnancy
PubMed: 36231358
DOI: 10.3390/ijerph191912045 -
BMC Pregnancy and Childbirth Jun 2017In 2009, the Nepal Ministry of Health and Population launched a national program for prevention of postpartum hemorrhage (PPH) during home births that features advance...
BACKGROUND
In 2009, the Nepal Ministry of Health and Population launched a national program for prevention of postpartum hemorrhage (PPH) during home births that features advance distribution of misoprostol to pregnant women. In the years since, the government has scaled-up the program throughout much of the country. This paper presents findings from the first large-scale assessment of the effectiveness of the advance distribution program.
METHODS
Data collection was carried out in nine districts and all three ecological zones. To assess knowledge, receipt and use of misoprostol, household interviews were conducted with 2070 women who had given birth within the past 12 months. To assess supply and provision of misoprostol, interviews were conducted with 270 Female Community Health Volunteers (FCHVs) and staff at 99 health facilities.
RESULTS
Among recently delivered women, only 15% received information about misoprostol and 13% received misoprostol tablets in advance of delivery. Yet 87% who received advance misoprostol and delivered at home used it for PPH prevention. Among FCHVs, 96% were providing advance misoprostol for PPH prevention; however 81% had experienced at least one misoprostol stock out within the past year. About one-half of FCHVs were providing incomplete information about the use of misoprostol; in addition, many did not discuss side effects, how to recognize PPH or where to go if PPH occurs. Among health facilities, just one-half had sufficient misoprostol stock, while 95% had sufficient oxytocin stock, at the time of this assessment.
CONCLUSIONS
In Nepal, women who receive advance misoprostol are both willing and able to use the medication for PPH prevention during home births. However the supply and personnel challenges identified raise questions about scalability and impact of the program over the long-term. Further assessment is needed.
Topics: Adolescent; Adult; Community Health Workers; Female; Health Facilities; Health Knowledge, Attitudes, Practice; Humans; Interviews as Topic; Misoprostol; Nepal; Oxytocics; Oxytocin; Patient Education as Topic; Postpartum Hemorrhage; Pregnancy; Program Evaluation; Volunteers; Young Adult
PubMed: 28583092
DOI: 10.1186/s12884-017-1347-z -
Journal of Cancer Research and... 2022To investigate the ease of tandem application and external os identification by giving sublingual misoprostol before initiation of intracavitary brachytherapy in cancer... (Randomized Controlled Trial)
Randomized Controlled Trial
AIM
To investigate the ease of tandem application and external os identification by giving sublingual misoprostol before initiation of intracavitary brachytherapy in cancer cervix patients.
MATERIALS AND METHODS
36 patients with cervical cancer stage IIIB which were supposed to undergo intracavitary brachytherapy(ICBT) were randomly divided into 2 subgroups, group A patients receiving misoprostol and group B not receiving misoprostol.Misoprostol 400 mcg was given sublingually 3 hrs prior to the procedure. The efficacy of the drug was measured as per the ease of identification of os and easier tandem application and amount of bleeding during procedure.
RESULTS
Application of tandem and identification of external os was easier and amount of bleeding was also less in patients that were administered sublingual misoprostol.
CONCLUSION
Sublingual Misoprostol given before ICBT helps in cervical ripening and thus leads to easier os recognition and central tandem application and reduce overall anaesthesia time.
Topics: Pregnancy; Female; Humans; Misoprostol; Brachytherapy; Uterine Cervical Neoplasms; Cervix Uteri; Carcinoma
PubMed: 36412412
DOI: 10.4103/jcrt.JCRT_116_20 -
International Journal of Gynaecology... Feb 2019To assess misoprostol availability at community pharmacies and determine factors affecting misoprostol prescription for medical abortion.
OBJECTIVE
To assess misoprostol availability at community pharmacies and determine factors affecting misoprostol prescription for medical abortion.
METHODS
A cross-sectional quantitative survey of randomly sampled community pharmacies and their corresponding pharmacists/pharmacy workers was conducted in the city of Accra, Ghana. Structured questionnaires were administered to collect data between May 1 and July 28, 2016. Descriptive statistics (frequencies and proportions) and bivariate and logistic regression analysis were used to analyze the data.
RESULTS
Of the 165 community pharmacies surveyed, approximately half (83 [50.3%]) stocked misoprostol. Availability of misoprostol however decreased when moving from first class to third class residential areas. 44 (26.7%) of the respondents had prescribed the drug at some time for medical abortion, but 140 (84.6%) indicated they would not prescribe the drug for medical abortion in future. Factors that significantly predicted misoprostol prescription for medical abortion included sex of the pharmacist/pharmacy worker, demand, and availability of misoprostol.
CONCLUSIONS
Demand for misoprostol for medical abortion was found to be high but only half of community pharmacies stocked it, and most pharmacy workers did not wish to prescribe the drug. If community pharmacies are to effectively contribute to expanding access to safe abortion services in Ghana, the disparity between misoprostol provision and demand needs to be addressed.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Attitude of Health Personnel; Cross-Sectional Studies; Female; Ghana; Health Services Accessibility; Humans; Male; Misoprostol; Pharmacies; Pharmacists; Pregnancy; Surveys and Questionnaires
PubMed: 30451283
DOI: 10.1002/ijgo.12717 -
Contraception Apr 2022In this commentary, we distill key messages from a new framework for self-managed medication abortion developed by Global Doctors for Choice. Since Global Doctors for...
In this commentary, we distill key messages from a new framework for self-managed medication abortion developed by Global Doctors for Choice. Since Global Doctors for Choice supports doctors working in different contexts around the world, the document also highlights clinical concerns and advocacy opportunities for clinicians in both low- and high-resource settings, and in places with varying legal and administrative restrictions on abortion.
Topics: Abortion, Induced; Abortion, Spontaneous; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Self-Management
PubMed: 34971608
DOI: 10.1016/j.contraception.2021.12.003 -
BMJ Open Gastroenterology Jun 2024The management of non-alcoholic steatohepatitis (NASH) is an unmet clinical need. Misoprostol, a structural analogue of naturally occurring prostaglandin E1, has been... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
The management of non-alcoholic steatohepatitis (NASH) is an unmet clinical need. Misoprostol, a structural analogue of naturally occurring prostaglandin E1, has been reported to decrease proinflammatory cytokine production and may have a potential role in treating NASH. We aimed to evaluate the efficacy and safety of misoprostol in treating patients with NASH.
METHODS
In this phase 2, double-blind, randomised, placebo-controlled trial, patients with NASH were randomly assigned in a 1:1 ratio to receive 200 µg of misoprostol or placebo thrice daily for 2 months. The primary endpoint was an improvement in liver function tests (LFTs), interleukin-6 (IL-6) and endotoxin levels. The secondary endpoint was improvement in insulin resistance, dyslipidaemia, hepatic fibrosis and hepatic steatosis.
RESULTS
A total of 50 patients underwent randomisation, of whom 44 (88%) were males. The age range was 25-64 years (mean±SE of mean (SEM) 38.1±1.4). 19 (38%) patients had concomitant type 2 diabetes mellitus. 32 (64%) patients were either overweight or obese. At the end of 2 months' treatment, a reduction in total leucocyte count (TLC) (p=0.005), alanine aminotransferase (ALT) (p<0.001), aspartate aminotransferase (AST) (p=0.002) and controlled attenuation parameter (CAP) (p=0.003) was observed in the misoprostol group, whereas placebo ensued a decline in ALT (p<0.001), AST (p=0.018), gamma-glutamyl transferase (GGT) (p=0.003), CAP (p=0.010) and triglycerides (p=0.048). There was no diminution in insulin resistance, hepatic fibrosis (elastography) and dyslipidaemia in both groups. However, misoprostol resulted in a significant reduction in CAP as compared with the placebo group (p=0.039). Moreover, in the misoprostol group, pretreatment and post-treatment IL-6 and endotoxin levels remained stable, while in the placebo group, an increase in the IL-6 levels was noted (p=0.049). Six (12%) patients had at least one adverse event in the misoprostol group, as did five (10%) in the placebo group. The most common adverse event in the misoprostol group was diarrhoea. No life-threatening events or treatment-related deaths occurred in each group.
CONCLUSION
Improvement in the biochemical profile was seen in both misoprostol and placebo groups without any statistically significant difference. However, there was more improvement in steatosis, as depicted by CAP, in the misoprostol group and worsening of IL-6 levels in the placebo group.
TRIAL REGISTRATION NUMBER
NCT05804305.
Topics: Humans; Male; Female; Non-alcoholic Fatty Liver Disease; Middle Aged; Double-Blind Method; Adult; Misoprostol; Interleukin-6; Treatment Outcome; Insulin Resistance; Liver Cirrhosis; Liver Function Tests; Liver
PubMed: 38844374
DOI: 10.1136/bmjgast-2023-001342 -
PloS One 2020Misoprostol is listed in the WHO essential medicines list and can be used for induction of labour, for prevention and treatment of post-partum haemorrhage, and for...
Misoprostol is listed in the WHO essential medicines list and can be used for induction of labour, for prevention and treatment of post-partum haemorrhage, and for abortions. The compound is unstable, and substandard misoprostol preparations have been detected in low- and middle-income countries. We now investigated the stability of misoprostol tablets according to the international guidelines for stability testing of pharmaceutical products. Three brands (four batches) of misoprostol tablets were collected in Malawi and Rwanda: the originator product, a WHO-prequalified product, and a generic product without WHO prequalification. A further batch of the originator product was collected in Germany. To investigate the effect of damage to the primary packaging, additional blister strips of one sample were intentionally damaged with a needle and investigated in parallel. Samples were placed in stability chambers for six months at 40°C/75% relative humidity (RH) and at 25°C/60% RH. After 0, 1, 2, 3 and 6 months, misoprostol content was determined according to the International Pharmacopeia. At 40°C/75% RH, all samples showed a decline of misoprostol content, but four of the batches still remained within the pharmacopeial specifications, while one of the two batches of the generic product without WHO-prequalification showed a final content of 86.2% which is out of specifications. Damage to the primary packaging greatly decreased stability, resulting in a final content of only 48.2% of the declared misoprostol amount. At 25°C/60% RH all samples remained in specifications for six months, even the sample with the damaged blister. Dissolution of misoprostol remained in specifications of the pharmacopoeia for six months for all batches, except for the sample with damaged blisters stored at 40°C/75% RH. This study confirms that the stability of misoprostol tablets must be ensured by intact, good-quality primary packaging. Careful supplier qualification is required in the procurement process.
Topics: Chromatography, High Pressure Liquid; Drug Packaging; Drug Stability; Humidity; Malawi; Misoprostol; Rwanda; Tablets; Temperature
PubMed: 32877459
DOI: 10.1371/journal.pone.0238628 -
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 -
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 -
Equine Veterinary Journal May 2019Misoprostol is an E prostanoid (EP) 2, 3 and 4 receptor agonist that is anecdotally used to treat and prevent NSAID-induced GI injury in horses. Misoprostol elicits...
BACKGROUND
Misoprostol is an E prostanoid (EP) 2, 3 and 4 receptor agonist that is anecdotally used to treat and prevent NSAID-induced GI injury in horses. Misoprostol elicits anti-inflammatory effects in vivo in men and rodents, and inhibits TNFα production in equine leucocytes in vitro.
OBJECTIVE
Define the pharmacokinetic parameters of oral misoprostol in horses, and determine the inhibitory effect of oral misoprostol administration on equine leucocyte TNFα production in an ex vivo inflammation model.
STUDY DESIGN
Pharmacokinetic study, ex vivo experimental study.
METHODS
Six healthy adult horses of mixed breeds were used. In phase one, horses were given 5 μg/kg misoprostol orally, and blood was collected at predetermined times for determination of misoprostol free acid (MFA) by UHPLC-MS/MS. Pharmacokinetic parameters were calculated. In phase two, horses were dosed as in phase one, and blood was collected at T0, 0.5, 1 and 4 h following misoprostol administration for leucocyte isolation. Leucocytes were stimulated with 100 ng/mL LPS, and TNFα mRNA concentrations were determined via quantitative real-time PCR.
RESULTS
About 5 μg/kg oral misoprostol produced a rapid time to maximum concentration (T ) of 23.4 ± 2.4 min, with a maximum concentration (C ) of 0.29 ± 0.07 ng/mL and area under the curve (AUC ) of 0.4 ± 0.12 h ng/mL. LPS stimulation of equine leucocytes ex vivo significantly increased TNFα mRNA concentrations, and there was no significant effect of misoprostol even at the T .
MAIN LIMITATIONS
Only a single dose was used, and sample size was small.
CONCLUSIONS
Misoprostol is rapidly absorbed following oral administration in horses, and a single 5 μg/kg dose had no significant inhibitory effect on ex vivo LPS-stimulated TNFα mRNA production in leucocytes. Further studies analysing different dosing strategies, including repeat administration or combination with other anti-inflammatory drugs, are warranted.
Topics: Abortifacient Agents, Nonsteroidal; Administration, Oral; Animals; Area Under Curve; Cells, Cultured; Horse Diseases; Horses; Inflammation; Leukocytes; Misoprostol
PubMed: 30256450
DOI: 10.1111/evj.13024