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Ciencia & Saude Coletiva Aug 2022The use of misoprostol for abortifacient purposes is a phenomenon observed in Brazil since the late 1980s. The drug started to be used at that time for self-induced... (Review)
Review
The use of misoprostol for abortifacient purposes is a phenomenon observed in Brazil since the late 1980s. The drug started to be used at that time for self-induced abortion, when it began to be commercialized for the treatment of peptic ulcer. Its access was restricted from 1998 onwards, but the drug continues to be commercialized illegally. The objective of this article is to summarize the knowledge produced by research in Brazil about induced abortion and the use of misoprostol. An integrative review of original studies carried out in Brazil and published in journals indexed in SciELO, PubMed and Lilacs databases was performed. The search found 68 titles, and 28 articles were included in the review. Most women who induced pregnancy interruption were young and did it before 15 gestational weeks. The rate of misoprostol use ranged from 89% to 36%. This drug is effective for terminating pregnancy in the first trimester and has a low rate of complications. However, the more socially vulnerable the woman is, the greater are the health risks in the abortion process. The conclusion is that the purchase of misoprostol as an abortifacient is facilitated, despite it being prohibited, and its complications are associated with the context of vulnerability of the pregnant woman.
Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortion, Criminal; Abortion, Induced; Female; Humans; Misoprostol; Pregnancy
PubMed: 35894320
DOI: 10.1590/1413-81232022278.03102022 -
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 -
Taiwanese Journal of Obstetrics &... Sep 2011Misoprostol, a synthetic prostaglandin E1 analog, is initially used to prevent peptic ulcer. The initial US Food and Drug Administration-approved indication in the... (Review)
Review
Misoprostol, a synthetic prostaglandin E1 analog, is initially used to prevent peptic ulcer. The initial US Food and Drug Administration-approved indication in the product labeling is the treatment and prevention of intestinal ulcer disease resulting from nonsteroidal anti-inflammatory drugs use. In recent two decades, misoprostol has approved to be an effective agent for termination of pregnancy in various gestation, cervical ripening, labor induction in term pregnancy, and possible management of postpartum hemorrhage. For the termination of second-trimester pregnancy using the combination of mifepristone and misoprostol seems to have the highest efficacy and the shortest time interval of abortion. When mifepristone is not available, misoprostol alone is a good alternative. Misoprostol, 400 μg given vaginally every 3-6 hours, is probably the optimal regimen for second-trimester abortion. More than 800 μg of misoprostol is likely to have more side effects, especially diarrhea. Although misoprostol can be used in women with scarred uterus for termination of second-trimester pregnancy, it is recommended that women with a scarred uterus should receive lower doses and do not double the dose if there is no initial response. It is also important for us to recognize the associated teratogenic effects of misoprostol and thorough consultation before prescribing this medication to patients regarding these risks, especially when failure of abortion occurs, is needed.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Female; Fetal Diseases; Humans; Misoprostol; Pregnancy; Pregnancy Trimester, Second; Prenatal Diagnosis
PubMed: 22030039
DOI: 10.1016/j.tjog.2011.07.003 -
The Journal of Maternal-fetal &... Dec 2024This study aims to compare the safety and efficacy of misoprostol administered orally and vaginally in obese pregnant women at term with either gestational hypertension...
OBJECTIVE
This study aims to compare the safety and efficacy of misoprostol administered orally and vaginally in obese pregnant women at term with either gestational hypertension or diabetes.
METHODS
A total of 264 pregnant women were enrolled and categorized into two groups based on their primary condition: hypertension (134 cases) or diabetes mellitus (130 cases) and were further divided into subgroups for misoprostol administration: orally (Oral group) or vaginally (Vaginal group). The primary outcomes measured were changes in the Bishop score following treatment, induction of labor (IOL) success rates, requirement for oxytocin augmentation, duration of labor, mode of delivery, and cesarean section rates.
RESULTS
Significant enhancements in Bishop scores, decreased cesarean section rates and increased success rates of IOL were noted in both administration groups. The incidence of vaginal delivery within 24 h was significantly higher in the Vaginal group compared to the Oral group. Adverse effects, including nausea, uterine overcontraction, hyperfrequency of uterine contraction and uterine hyperstimulation without fetal heart rate deceleration, were significantly more prevalent in the Vaginal group than in the Oral group.
CONCLUSION
Misoprostol administration, both orally and vaginally, proves effective for labor induction in obese pregnant women with hypertension or diabetes. However, the oral route presents a lower risk of adverse maternal and neonatal outcomes, suggesting its preference for safer labor induction in this demographic.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Misoprostol; Oxytocics; Pregnant Women; Administration, Intravaginal; Cesarean Section; Labor, Induced; Administration, Oral; Hypertension, Pregnancy-Induced; Diabetes Mellitus
PubMed: 38485520
DOI: 10.1080/14767058.2024.2327573 -
Archives of Gynecology and Obstetrics Sep 2023Misoprostol is a synthetic PGE analogue that is used for induction of labour. Current guidelines support the use of doses that do not exceed 25 mcg in order to limit... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Misoprostol is a synthetic PGE analogue that is used for induction of labour. Current guidelines support the use of doses that do not exceed 25 mcg in order to limit maternal and neonatal adverse outcomes. The present meta-analysis investigates the efficacy and safety of oral compared to vaginally inserted misoprostol in terms of induction of labor and adverse peripartum outcomes.
METHODS
We searched Medline, Scopus, the Cochrane Central Register of Controlled Trials CENTRAL, Google Scholar, and Clinicaltrials.gov databases from inception till April 2022. Randomized controlled trials that assessed the efficacy of oral misoprostol (per os or sublingual) compared to vaginally inserted misoprostol. Effect sizes were calculated in R. Sensitivity analysis was performed to evaluate the possibility of small study effects, p-hacking. Meta-regression and subgroup analysis according to the dose of misoprostol was also investigated. The methodological quality of the included studies was assessed by two independent reviewers using the risk of bias 2 tool. Quality of evidence for primary outcomes was evaluated under the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, ranging from very low to high.
RESULTS
Overall, 57 studies were included that involved 10,975 parturient. Their risk of bias ranged between low-moderate. There were no differences among the routes of intake in terms of successful vaginal delivery within 24 h (RR 0.90, 95% CI 0.80) and cesarean section rates (RR 0.92, 95% CI 0.82, 1.04). Sublingual misoprostol was superior compared to vaginal misoprostol in reducing the interval from induction to delivery (MD - 1.11 h, 95% CI - 2.06, - 0.17). On the other hand, per os misoprostol was inferior compared to vaginal misoprostol in terms of this outcome (MD 3.45 h, 95% CI 1.85, 5.06). Maternal and neonatal morbidity was not affected by the route or dose of misoprostol.
CONCLUSION
The findings of our study suggest that oral misoprostol intake is equally safe to vaginal misoprostol in terms of inducing labor at term. Sublingual intake seems to outperform the per os and vaginal routes without increasing the accompanying morbidity. Increasing the dose of misoprostol does not seem to increase its efficacy.
CLINICAL TRIAL REGISTRATION
Open Science Framework ( https://doi.org/10.17605/OSF.IO/V9JHF ).
Topics: Infant, Newborn; Pregnancy; Humans; Female; Misoprostol; Oxytocics; Cesarean Section; Labor, Induced; Administration, Sublingual
PubMed: 36472645
DOI: 10.1007/s00404-022-06867-9 -
BMC Pregnancy and Childbirth Nov 2019Early pregnancy failure (EPF) is a common complication of pregnancy. If women do not abort spontaneously, they will undergo medical or surgical treatment in order to... (Comparative Study)
Comparative Study
Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: study protocol for a randomized double blinded placebo-controlled comparison (Triple M Trial).
BACKGROUND
Early pregnancy failure (EPF) is a common complication of pregnancy. If women do not abort spontaneously, they will undergo medical or surgical treatment in order to remove the products of conception from the uterus. Curettage, although highly effective, is associated with a risk of complications; medical treatment with misoprostol is a safe and less expensive alternative. Unfortunately, after 1 week of expectant management in case of EPF, medical treatment with misoprostol has a complete evacuation rate of approximately 50%. Misoprostol treatment results may be improved by pre-treatment with mifepristone; its effectiveness has already been proven for other indications of pregnancy termination. This study will test the hypothesis that, in EPF, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes).
METHODS
The trial will be performed multi-centred, prospectively, two-armed, randomised, double-blinded and placebo-controlled. Women with confirmed EPF by ultrasonography (6-14 weeks), managed expectantly for at least 1 week, can be included and randomised to pre-treatment with oral mifepristone (600 mg) or oral placebo (identical in appearance). Randomisation will take place after receiving written consent to participate. In both arms pre-treatment will be followed by oral misoprostol, which will start 36-48 h later consisting of two doses 400 μg (4 hrs apart), repeated after 24 h if no tissue is lost. Four hundred sixty-four women will be randomised in a 1:1 ratio, stratified by centre. Ultrasonography 2 weeks after treatment will determine short term treatment effect. When the gestational sac is expulsed, expectant management is advised until 6 weeks after treatment when the definitive primary endpoint, complete or incomplete evacuation, will be determined. A sonographic endometrial thickness < 15 mm using only the allocated therapy by randomisation is considered as successful treatment. Secondary outcome measures (patient satisfaction, complications, side effects and costs) will be registered using a case report form, patient diary and validated questionnaires (Short Form 36, EuroQol-VAS, Client Satisfaction Questionnaire, iMTA Productivity Cost Questionnaire).
DISCUSSION
This trial will answer the question if, in case of EPF, after at least 1 week of expectant management, sequential treatment with mifepristone and misoprostol is more effective than misoprostol alone to achieve complete evacuation of the products of conception.
TRIAL REGISTRATION
Clinicaltrials.gov (d.d. 02-07-2017): NCT03212352. Trialregister.nl (d.d. 03-07-2017): NTR6550. EudraCT number (d.d. 07-08-2017): 2017-002694-19. File number Commisie Mensgebonden Onderzoek (d.d. 07-08-2017): NL 62449.091.17.
Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Incomplete; Adolescent; Adult; Cost-Benefit Analysis; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Multicenter Studies as Topic; Patient Satisfaction; Pregnancy; Pregnancy Trimester, First; Prospective Studies; Randomized Controlled Trials as Topic; Ultrasonography; Watchful Waiting; Young Adult
PubMed: 31775677
DOI: 10.1186/s12884-019-2497-y -
Bulletin of the World Health... Sep 2009To review maternal deaths and the dose-related effects of misoprostol on blood loss and pyrexia in randomized trials of misoprostol use for the prevention or treatment... (Review)
Review
OBJECTIVE
To review maternal deaths and the dose-related effects of misoprostol on blood loss and pyrexia in randomized trials of misoprostol use for the prevention or treatment of postpartum haemorrhage.
METHODS
We searched the Cochrane Controlled Trials Register and Pubmed, without language restrictions, for '(misoprostol AND postpartum) OR (misoprostol AND haemorrhage) OR (misoprostol AND hemorrhage)', and we evaluated reports identified through the Cochrane Pregnancy and Childbirth Group search strategy. Randomized trials comparing misoprostol with either placebo or another uterotonic to prevent or treat postpartum haemorrhage were checked for eligibility. Data were extracted, tabulated and analysed with Reviewer Manager (RevMan) 4.3 software.
FINDINGS
We included 46 trials with more than 40,000 participants in the final analysis. Of 11 deaths reported in 5 trials, 8 occurred in women receiving >or= 600 microg of misoprostol (Peto odds ratio, OR: 2.49; 95% confidence interval, CI: 0.76-8.13). Severe morbidity, defined as the need for major surgery, admission to intensive care, organ failure or body temperature >or= 40 degrees C, was relatively infrequent. In prevention trials, severe morbidity was experienced by 16 of 10,281 women on misoprostol and by 16 of 10,292 women on conventional uterotonics; in treatment trials, it was experienced by 1 of 32 women on misoprostol and by 1 of 32 women on conventional uterotonics. Misoprostol recipients experienced more adverse events than placebo recipients: 8 of 2070 versus 5 of 2032, respectively, in prevention trials, and 5 of 196 versus 2 of 202, respectively, in treatment trials. Meta-analysis of direct and adjusted indirect comparisons of the results of randomized trials showed no evidence that 600 microg are more effective than 400 microg for preventing blood loss > 1000 ml (relative risk, RR: 1.02; 95% CI: 0.71-1.48). Pyrexia was more than twice as common among women who received > 600 microg rather than 400 microg of misoprostol (RR: 2.53; 95% CI: 1.78-3.60).
CONCLUSION
Further research is needed to more accurately assess the potential beneficial and harmful effects of misoprostol and to determine the smallest dose that is effective and safe. In this review, 400 microg of misoprostol were found to be safer than > 600 microg and just as effective.
Topics: Female; Humans; Labor Stage, Third; Maternal Mortality; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 19784446
DOI: 10.2471/blt.08.055715 -
Revista Da Associacao Medica Brasileira... 2023This study aimed to analyze the effects of Foley catheter combined with misoprostol in the labor induction process. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
This study aimed to analyze the effects of Foley catheter combined with misoprostol in the labor induction process.
METHODS
This is a nonblinded, block randomized, controlled trial that compared the association between transcervical Foley catheter/vaginal misoprostol 25 μg combination and vaginal misoprostol 25 μg alone in normal-risk and healthy pregnant women undergoing labor induction in the south of Brazil.
RESULTS
A total of 230 patients with indications for labor induction were evaluated and classified into the "combined" group (Foley catheter plus misoprostol), consisting of 107 patients, and the "misoprostol" group (misoprostol only), consisting of 123 patients. The "combined" group was observed to have a shorter labor induction time (p=0.008). In addition, there was a lower need for misoprostol use for overall cervical ripening (p<0.001) and a lower relative risk of needing a second, third, or fourth misoprostol tablet in the "combined" group (risk ratio [RR] 0.80, 95% confidence interval [CI] 0.71-0.91; RR 0.41; 95%CI 0.31-0.56; and RR 0.29, 95%CI 0.17-0.52, respectively) (p<0.001). No statistically significant difference was found in induction failure rate, cesarean section rate, or perinatal outcomes.
CONCLUSION
A combination of methods leads to shorter labor induction, lower need for misoprostol doses, and lower risk of cesarean section, with no increase in the rate of perinatal complications. REBEC number is RBR-7xcjz3z.
Topics: Pregnancy; Female; Humans; Misoprostol; Oxytocics; Cesarean Section; Administration, Intravaginal; Labor, Induced; Catheters
PubMed: 36629651
DOI: 10.1590/1806-9282.20220897 -
Journal of Healthcare Engineering 2022In order to systematically evaluate the clinical efficacy and safety of misoprostol versus oxytocin in the prevention of postpartum hemorrhage, this paper provides... (Meta-Analysis)
Meta-Analysis
In order to systematically evaluate the clinical efficacy and safety of misoprostol versus oxytocin in the prevention of postpartum hemorrhage, this paper provides evidence-based reference for clinical medication, computerized retrieval of Chinese biomedical literature database (CBM), PubMed, Embase, Cochrane Library, and clinical trials. The retrieval period is from the establishment of each database to October 1, 2021. Published randomized controlled trials (RCTS) are included in this study. The literature is screened and evaluated according to inclusion and exclusion criteria, and meta-analysis is performed using RevMan 5.3 software. A total of 13 RCTS are included, with a total of 24754 parturients. The meta-analysis shows the average blood loss (SMD = 0.10, 95% CI (-0.11, 0.32), =0.35), the time of the third stage of labor (SMD = 0, 95% CI (-0.07, 0.08), =0.95), and blood transfusion rate (RR = 0.80, 95% CI (0.63, 1.02), =0.07). However, the incidences of shivering (RR = 2.61, 95% CI (1.79, 0.81), < 0.00001) and vomiting (RR = 2.78, 95% CI (1.85, 4.18), < 0.00001) are significantly higher than those in oxytocin group. The effect of misoprostol on preventing postpartum hemorrhage is similar to that of oxytocin, but the incidence of adverse reactions is high, and the occurrence of adverse reactions should be closely watched in the use process. Due to the limitations of the included studies, multicenter, large-sample, and high-quality RCTS are still needed in the future to further verify this conclusion.
Topics: Female; Humans; Misoprostol; Multicenter Studies as Topic; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35449871
DOI: 10.1155/2022/3254586 -
BMC Pregnancy and Childbirth Apr 2023The Induction of labor is the most common obstetric procedure in daily practice. Introducing propranolol as a new drug to augment the action of prostaglandins will help... (Randomized Controlled Trial)
Randomized Controlled Trial
A pilot study to compare propranolol and misoprostol versus misoprostol and placebo for induction of labor in primigravidae; a randomized, single-blinded, placebo-controlled trial.
BACKGROUND
The Induction of labor is the most common obstetric procedure in daily practice. Introducing propranolol as a new drug to augment the action of prostaglandins will help in the induction process and decrease CS rates. Several researchers have used propranolol in the augmentation of labor.
AIM
This pilot study compares propranolol and misoprostol versus misoprostol alone for labor induction in primigravids.
METHODS
This is a Randomized clinical trial, single-blinded, placebo-controlled trial at Ain Shams University Maternity hospital. This study included 128 pregnant full-term primigravid women candidates for labor induction, randomized into two groups. All candidates underwent labor induction with 25 µg of vaginal misoprostol. Group I received 20 mg of oral propranolol tablets, while group II received sugary pills as a placebo. Candidates who responded successfully to induction were assessed for possible augmentation of labor by amniotomy or oxytocin infusion. The Primary outcome was induction to delivery interval, while the secondary outcomes were the duration of the latent phase, mode of delivery, and APGAR score of the neonate.
RESULTS
The induction-delivery time was (11.8 ± 8.1 h. vs. 12.6 ± 8.9 h., P value = 0.027) and the duration of the latent phase of labor (7.9 ± 5.6 h. vs. 9.2 ± 6.03 h., P value = 0.017) were significantly shorter in the group of misoprostol and propranolol compared to the group of misoprostol and placebo. There was no statistically significant difference between both groups' mode of delivery, indications for cesarean section, misoprostol, and oxytocin doses, or neonatal outcome. (P value > 0.05).
CONCLUSION
Propranolol, when used with misoprostol for induction of labor, results in augmentation of action of misoprostol and a significantly shorter induction-delivery interval.
TRIAL REGISTRATION
We retrospectively registered this trial in clinicaltrial.gov on 01/09/2020 (NCT04533841). https://clinicaltrials.gov/ct2/show/NCT04533841.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Administration, Intravaginal; Cesarean Section; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Pilot Projects; Propranolol
PubMed: 37016326
DOI: 10.1186/s12884-023-05537-1