-
Journal of Obstetrics and Gynaecology... Dec 2020Abortion-related complications remain one of the leading causes of maternal morbidity and mortality worldwide. Nearly half of all abortions are unsafe, and the vast... (Review)
Review
OBJECTIVE
Abortion-related complications remain one of the leading causes of maternal morbidity and mortality worldwide. Nearly half of all abortions are unsafe, and the vast majority of these occur in low- and middle-income countries. The use of mifepristone with misoprostol for medical abortion has been proposed and implemented to improve abortion safety.
DATA SOURCES
A systematic review of the literature was conducted in PubMed, Embase, Cochrane, and CINAHL.
STUDY SELECTION
Criteria for study inclusion were first-trimester abortion, use of mifepristone with misoprostol, and low- or middle-income country status as designated by the World Health Organization.
DATA EXTRACTION
Results for effectiveness, safety, acceptability, and qualitative information were assessed.
DATA SYNTHESIS
The literature search resulted in 181 eligible articles, 52 of which met our criteria for inclusion. A total of 34 publications reported effectiveness data on 25 385 medical abortions. The average effectiveness rate with mifepristone 200 mg and misoprostol 800 µg was 95% up to 63 days gestation. A sensitivity analysis was performed to assume that all women lost to follow-up failed treatment, and the recalculated effectiveness rate remained high at 93%. The average continuing pregnancy rate was 0.6%. A total of 22 publications reported safety and acceptability data on 17 381 medical abortions. Only 0.8% abortions required presentation to hospital, and 87% of patients found the side effects of treatment acceptable. Overall, 95% of women were satisfied with their medical abortion, 94% would choose the method again, and 94% would recommend this method to a friend. A total of 16 publications reported qualitative results and the majority supported positive patient experiences with medical abortion.
CONCLUSIONS
Mifepristone and misoprostol is highly effective, safe, and acceptable to women in low- and middle-income countries, making it a feasible option for reducing maternal morbidity and mortality worldwide.
Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Developing Countries; Female; Humans; Mifepristone; Misoprostol; Patient Acceptance of Health Care; Pregnancy; Treatment Outcome
PubMed: 32912726
DOI: 10.1016/j.jogc.2020.04.006 -
Molecules (Basel, Switzerland) Oct 2022The aim of this study was establishment of an UHPLC-QqQ-MS/MS method for the deter-mination of misoprostol acid in biological specimens in cases of pharmacological... (Review)
Review
The aim of this study was establishment of an UHPLC-QqQ-MS/MS method for the deter-mination of misoprostol acid in biological specimens in cases of pharmacological abortions. Forensic toxicological examination was performed in three different biological samples (whole blood, placenta and fetal liver). The validation parameters of the method were as follows: limit of detection: 25 pg/mL; limit of quantification: 50 pg/mL, coefficient of determination: >0.999 (R2), intra- and interday accuracy and precision: not greater than 13.7%. The recovery and matrix effect were in the range of 88.3−95.1% and from −11.7 to −4.9%, respectively. Toxicological analysis of the mother’s blood (collected two days after pregnancy termination) did not reveal any abortifacients; however, misoprostol acid was found in the placenta (793 pg/g) and fetal liver (309 pg/g). The second case involved a fetus found near a garbage container. The concentration of misoprostol acid in the placenta was 2332 pg/g. In the presented study, an extensive literature review of misoprostol pharmacokinetics studies was performed. To our knowledge, the UHPLC-QqQ-MS/MS technique presented in this paper is the first quantitative method applied for forensic toxicological purposes. In addition, postmortem concentrations of misoprostol acid in miscarried fetuses due to illegal abortions were reported for the first time.
Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Female; Humans; Misoprostol; Pregnancy; Tandem Mass Spectrometry
PubMed: 36235071
DOI: 10.3390/molecules27196534 -
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 -
Contraception Aug 2020To compare time from misoprostol initiation to fetal expulsion for mifepristone-misoprostol versus misoprostol-alone regimens of medication abortion performed at...
OBJECTIVE
To compare time from misoprostol initiation to fetal expulsion for mifepristone-misoprostol versus misoprostol-alone regimens of medication abortion performed at ≥24 weeks' gestation.
STUDY DESIGN
We conducted a retrospective study of medication abortion performed at ≥24 weeks' gestation between May 2016 and January 2018 at one site, comparing outcomes of patients receiving mifepristone-misoprostol versus misoprostol alone during two periods. All patients received feticidal injection and laminaria; the mifepristone-misoprostol group also received mifepristone 200 mg orally around the time of initial laminaria. Beginning 24-72 h later (depending on cervical assessment), both groups received misoprostol buccally every two hours.
RESULTS
Analyses included 257 patients in the mifepristone-misoprostol group and 152 patients in the misoprostol-alone group. Median time from misoprostol initiation to fetal expulsion was similar between groups (4.8 h vs. 4.9 h; p = 0.43). Patients in the mifepristone-misoprostol group received less misoprostol overall (median [IQR]: 800 mcg [800-1200 mcg] vs. 1200 mcg [800-1600 mcg]; p < 0.01) and fewer patients received a second round of laminaria (n = 56, 22% vs. n = 58, 33%; p < 0.01) than the misoprostol-alone group. Seven patients (2%) were transferred to a hospital for complications; this proportion did not vary by regimen.
CONCLUSIONS
Addition of mifepristone was not associated with a reduction in induction interval at ≥24 weeks. However, patients in the mifepristone-misoprostol group received a lower total dose of misoprostol and were less likely to require two days of laminaria. The clinical significance of these differences is unclear, but may have implications for patient experience. Both regimens had low rates of complications.
IMPLICATIONS
A randomized controlled trial comparing the mifepristone-misoprostol and misoprostol-alone regimens at ≥24 weeks is needed, as is evidence on patient perspectives on these regimens. Given the existing evidence, either regimen is reasonable.
Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pregnancy; Retrospective Studies
PubMed: 32407810
DOI: 10.1016/j.contraception.2020.05.001 -
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 -
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 -
PloS One 2020To compare effectiveness and safety of oral misoprostol (50 μg every four hours as needed), low dose vaginal misoprostol (25 to 50 μg every six hours as needed), and... (Comparative Study)
Comparative Study Randomized Controlled Trial
OBJECTIVE
To compare effectiveness and safety of oral misoprostol (50 μg every four hours as needed), low dose vaginal misoprostol (25 to 50 μg every six hours as needed), and our established dinoprostone vaginal gel (one to two mg every six hours as needed) induction.
MATERIALS AND METHODS
Consenting women with a live term single cephalic fetus for indicated labor induction were randomized (3N = 511). Prior uterine surgery or non-reassuring fetal surveillance were exclusions. Concealed computer generated randomization was stratified and blocked. Newborns were assessed by a team unaware of group assignment. The primary outcome was time from induction at randomization to vaginal birth for initial parametric analysis. Sample size was based on mean difference of 240 minutes with α2 = 0.05 and power 95%. Non-parametric analysis was also pre-specified ranking cesareans as longest vaginal births.
RESULTS
Enrollment was from April 1999 to December 2000. Demographics were similar across groups. Analysis was by intent to treat, with no loss to follow up. Mean time (±SD) to vaginal birth was 1356 (±1033) minutes for oral misoprostol, 1530 (±3249) minutes for vaginal misoprostol, and 1208 (±613) minutes for vaginal dinoprostone (P = 0.46, ANOVA). Median times to vaginal birth were 1571, 1339, and 1451 minutes respectively (P = 0.46, Kruskal-Wallis). Vaginal births occurred within 24 hours in 44.9, 53.5 and 47.7% respectively (P = 0.27, χ2). There were no significant differences in Kaplan Meier survival analyses, cesareans, adverse effects, or maternal satisfaction. The newborn who met birth asphyxia criteria received vaginal misoprostol, as did. all three other newborns with cord artery pH<7.0 (P = 0.04, Fisher Exact).
CONCLUSION
There was no significant difference in effectiveness of the three groups. Profound newborn acidemia, though infrequent, occurred only with low dose vaginal misoprostol.
Topics: Administration, Intravaginal; Administration, Oral; Adult; Dinoprostone; Female; Humans; Infant, Newborn; Labor, Induced; Misoprostol; Oxytocics; Patient Satisfaction; Pregnancy; Treatment Outcome; Young Adult
PubMed: 31923193
DOI: 10.1371/journal.pone.0227245 -
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 -
Revista Brasileira de Ginecologia E... Dec 2023To assess the efficacy, safety, and acceptability of misoprostol in the treatment of incomplete miscarriage. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the efficacy, safety, and acceptability of misoprostol in the treatment of incomplete miscarriage.
DATA SOURCES
The PubMed, Scopus, Embase, Web of Science, Cochrane Library, and Clinical Trials databases (clinicaltrials.gov) were searched for the relevant articles, and search strategies were developed using a combination of thematic Medical Subject Headings terms and text words. The last search was conducted on July 4, 2022. No language restrictions were applied.
SELECTION OF STUDIES
Randomized clinical trials with patients of gestational age up to 6/7 weeks with a diagnosis of incomplete abortion and who were managed with at least 1 of the 3 types of treatment studied were included. A total of 8,087 studies were screened.
DATA COLLECTION
Data were synthesized using the statistical package Review Manager V.5.1 (The Cochrane Collaboration, Oxford, United Kingdom). For dichotomous outcomes, the odds ratio (OR) and 95% confidence interval (CI) were derived for each study. Heterogeneity between the trial results was evaluated using the standard test, I statistic.
DATA SYNTHESIS
When comparing misoprostol with medical vacuum aspiration (MVA), the rate of complete abortion was higher in the MVA group (OR = 0.16; 95%CI = 0.07-0.36). Hemorrhage or heavy bleeding was more common in the misoprostol group (OR = 3.00; 95%CI = 1.96-4.59), but pain after treatment was more common in patients treated with MVA (OR = 0.65; 95%CI = 0.52-0.80). No statistically significant differences were observed in the general acceptability of the treatments.
CONCLUSION
Misoprostol has been determined as a safe option with good acceptance by patients.
Topics: Pregnancy; Female; Humans; Infant; Misoprostol; Abortion, Incomplete; Abortion, Spontaneous; Pregnancy Trimester, First; Abortion, Induced
PubMed: 38141602
DOI: 10.1055/s-0043-1776029 -
The Cochrane Database of Systematic... Mar 2020The advent of medical abortion has improved access to safe abortion procedures. Medical abortion procedures involve either administering mifepristone followed by... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The advent of medical abortion has improved access to safe abortion procedures. Medical abortion procedures involve either administering mifepristone followed by misoprostol or a misoprostol-only regimen. The drugs are commonly administered in the presence of clinicians, which is known as provider-administered medical abortion. In self-administered medical abortion, drugs are administered by the woman herself without the supervision of a healthcare provider during at least one stage of the drug protocol. Self-administration of medical abortion has the potential to provide women with control over the abortion process. In settings where there is a shortage of healthcare providers, self-administration may reduce the burden on the health system. However, it remains unclear whether self-administration of medical abortion is effective and safe. It is important to understand whether women can safely and effectively terminate their own pregnancies when having access to accurate and adequate information, high-quality drugs, and facility-based care in case of complications.
OBJECTIVES
To compare the effectiveness, safety, and acceptability of self-administered versus provider-administered medical abortion in any setting.
SEARCH METHODS
We searched Cochrane Central Register of Controlled Trials, MEDLINE in process and other non-indexed citations, Embase, CINAHL, POPLINE, LILACS, ClinicalTrials.gov, WHO ICTRP, and Google Scholar from inception to 10 July 2019.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and prospective cohort studies with a concurrent comparison group, using study designs that compared medical abortion by self-administered versus provider-administered methods.
DATA COLLECTION AND ANALYSIS
Two reviewers independently extracted the data, and we performed a meta-analysis where appropriate using Review Manager 5. Our primary outcome was successful abortion (effectiveness), defined as complete uterine evacuation without the need for surgical intervention. Ongoing pregnancy (the presence of an intact gestational sac) was our secondary outcome measuring success or effectiveness. We assessed statistical heterogeneity with Chi tests and I statistics using a cut-off point of P < 0.10 to indicate statistical heterogeneity. Quality assessment of the data used the GRADE approach. We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We identified 18 studies (two RCTs and 16 non-randomized studies (NRSs)) comprising 11,043 women undergoing early medical abortion (≤ 9 weeks gestation) in 10 countries. Sixteen studies took place in low-to-middle income resource settings and two studies were in high-resource settings. One NRS study received analgesics from a pharmaceutical company. Five NRSs and one RCT did not report on funding; nine NRSs received all or partial funding from an anonymous donor. Five NRSs and one RCT received funding from government agencies, private foundations, or non-profit bodies. The intervention in the evidence is predominantly from women taking mifepristone in the presence of a healthcare provider, and subsequently taking misoprostol without healthcare provider supervision (e.g. at home). There is no evidence of a difference in rates of successful abortions between self-administered and provider-administered groups: for two RCTs, risk ratio (RR) 0.99, 95% confidence interval (CI) 0.97 to 1.01; 919 participants; moderate certainty of evidence. There is very low certainty of evidence from 16 NRSs: RR 0.99, 95% CI 0.97 to 1.01; 10,124 participants. For the outcome of ongoing pregnancy there may be little or no difference between the two groups: for one RCT: RR 1.69, 95% CI 0.41 to 7.02; 735 participants; low certainty of evidence; and very low certainty evidence for 11 NRSs: RR 1.28, 95% CI 0.65 to 2.49; 6691 participants. We are uncertain whether there are any differences in complications requiring surgical intervention, since we found no RCTs and evidence from three NRSs was of very low certainty: for three NRSs: RR 2.14, 95% CI 0.80 to 5.71; 2452 participants.
AUTHORS' CONCLUSIONS
This review shows that self-administering the second stage of early medical abortion procedures is as effective as provider-administered procedures for the outcome of abortion success. There may be no difference for the outcome of ongoing pregnancy, although the evidence for this is uncertain for this outcome. There is very low-certainty evidence for the risk of complications requiring surgical intervention. Data are limited by the scarcity of high-quality research study designs and the presence of risks of bias. This review provides insufficient evidence to determine the safety of self-administration when compared with administering medication in the presence of healthcare provider supervision. Future research should investigate the effectiveness and safety of self-administered medical abortion in the absence of healthcare provider supervision through the entirety of the medical abortion protocol (e.g. during administration of mifepristone or as part of a misoprostol-only regimen) and at later gestational ages (i.e. more than nine weeks). In the absence of any supervision from medical personnel, research is needed to understand how best to inform and support women who choose to self-administer, including when to seek clinical care.
Topics: Abortifacient Agents; Abortion, Induced; Female; Humans; Mifepristone; Misoprostol; Patient Safety; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic
PubMed: 32150279
DOI: 10.1002/14651858.CD013181.pub2