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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 -
International Journal of Gynaecology... Feb 2024Misoprostol is widely used for cervical ripening and labour induction as it is heat-stable and inexpensive. Oral misoprostol 25 μg given 2-hourly is recommended over... (Meta-Analysis)
Meta-Analysis Review
The efficacy and safety of 25 μg or 50 μg oral misoprostol versus 25 μg vaginal misoprostol given at 4- or 6-hourly intervals for induction of labour in women at or beyond term with live singleton pregnancies: A systematic review and meta-analysis.
BACKGROUND
Misoprostol is widely used for cervical ripening and labour induction as it is heat-stable and inexpensive. Oral misoprostol 25 μg given 2-hourly is recommended over vaginal misoprostol 25 μg given 6-hourly, but the need for 2-hourly fetal monitoring makes oral misoprostol impractical for routine use in high-volume obstetric units in resource-constrained settings.
OBJECTIVES
To compare the efficacy and safety of oral misoprostol initiated at 25 or 50 μg versus 25 μg vaginal misoprostol given at 4- to 6-hourly intervals for labor induction in women at or beyond term (≥ 37 weeks) with a single viable fetus and an unscarred uterus.
SEARCH STRATEGY
We identified eligible randomized, parallel-group, labor-induction trials from recent systematic reviews. We additionally searched PubMed, Cochrane CENTRAL, Epistemonikos, and clinical trials registries from February 1, 2020 to December 31, 2022 without language restrictions. Database-specific keywords for cervical priming, labor induction, and misoprostol were used.
SELECTION CRITERIA
We excluded labor-induction trials exclusively in women with ruptured membranes, in the third trimester, and those that initiated misoprostol at doses not specified in the review's objectives. The primary outcomes were vaginal birth within 24 h, cesarean section, perinatal mortality, neonatal morbidity, and maternal morbidity. The secondary outcomes were uterine hyperstimulation with fetal heart rate changes, and oxytocin augmentation.
DATA COLLECTION AND ANALYSIS
Two or more authors selected studies independently, assessed risk of bias, and extracted data. We derived pooled weighted risk ratios with 95% confidence intervals (CIs) for each outcome, subgrouping trials by the dose and frequency of misoprostol regimens. We used the I statistic to quantify heterogeneity and the random-effects model for meta-analysis when appropriate. We used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach to assess certainty (confidence) in the effect estimates.
MAIN RESULTS
Thirteen trials, from Canada, India, Iran, and the US, randomizing 2941 women at ≥37 weeks of gestation with an unfavorable cervix (Bishop score <6), met the eligibility criteria. Five misoprostol regimens were compared: 25 μg oral versus 25 μg vaginal, 4-hourly (three trials); 50 μg oral versus 25 μg vaginal, 4-hourly (five trials); 50 μg followed by 100 μg oral versus 25 μg vaginal, 4-hourly (two trials); 50 μg oral, 4-hourly versus 25 μg vaginal, 6-hourly (one trial); and 50 μg oral versus 25 μg vaginal, 6-hourly (two trials). The overall certainty in the evidence ranged from moderate to very low, due to high risk of bias in 11/13 trials (affecting all outcomes), unexplained heterogeneity (1/7 outcomes), indirectness (1/7 outcomes), and imprecision (4/7 outcomes). Vaginal misoprostol probably increased vaginal deliveries within 24 h compared with oral misoprostol (risk ratio [RR] 0.82, 95% CI 0.70-0.96; 11 trials, 2721 mothers; moderate-certainty evidence); this was more likely with 4-hourly than with 6-hourly vaginal regimens. The risk of cesarean sections did not appreciably differ (RR 1.00, 95% CI 0.80-1.26; 13 trials, 2941 mothers; very low-certainty evidence), although oral misoprostol 25 μg 4-hourly probably increased this risk compared with 25 μg vaginal misoprostol 4-hourly (RR 1.69, 95% CI 1.21-2.36; three trials, 515 mothers). The risk of perinatal mortality (RR 0.67, 95% CI 0.11-3.90; one trial, 196 participants; very low-certainty evidence), neonatal morbidity (RR 0.84, 95% CI 0.67-1.06; 13 trials, 2941 mothers; low-certainty evidence), and maternal morbidity (RR 0.83, 95% CI 0.48-1.44; 6 trials; 1945 mothers; moderate-certainty evidence) did not differ appreciably. The risk of uterine hyperstimulation with fetal heart rate changes may be lower with oral misoprostol (RR 0.70, 95% CI 0.52-0.95; 10 trials, 2565 mothers; low-certainty evidence). Oxytocin augmentation was probably more frequent with oral compared with vaginal misoprostol (RR 1.29, 95% CI 1.10-1.51; 13 trials, 2941 mothers; moderate-certainty evidence).
CONCLUSIONS
Low-dose, 4- to 6-hourly vaginal misoprostol regimens probably result in more vaginal births within 24 h and less frequent oxytocin use compared with low-dose, 4- to 6-hourly, oral misoprostol regimens. Vaginal misoprostol may increase the risk of uterine hyperstimulation with fetal heart changes compared with oral misoprostol, without increasing the risk of perinatal mortality, neonatal morbidity, or maternal morbidity. Indirect evidence indicates that 25 μg vaginal misoprostol 4-hourly may be more effective and as safe as the recommended 6-hourly vaginal regimen. This evidence could inform clinical decisions in high-volume obstetric units in resource-constrained settings.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Cervical Ripening; Cesarean Section; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Perinatal Death
PubMed: 37401143
DOI: 10.1002/ijgo.14970 -
Contraception Feb 2018
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Female; Humans; Mifepristone; Misoprostol; Personal Autonomy; Pregnancy
PubMed: 29242083
DOI: 10.1016/j.contraception.2017.12.006 -
Revista Brasileira de Ginecologia E... Jun 2023
Topics: Humans; Pregnancy; Female; Misoprostol; Obstetrics; Oxytocics; Gynecology
PubMed: 37494579
DOI: 10.1055/s-0043-1770931 -
Archives of Gynecology and Obstetrics Nov 2023This study evaluated the differences in treatment outcomes between misoprostol and surgical evacuation for the management of incomplete abortion.
PURPOSE
This study evaluated the differences in treatment outcomes between misoprostol and surgical evacuation for the management of incomplete abortion.
METHODS
This retrospective cohort study compared patients with a clinical diagnosis of incomplete abortion who underwent surgical or pharmaceutical (misoprostol) intervention, 2014-2017. Demographics, sonographic results, treatment follow-up, and post-intervention data on retained products of conception were retrieved. Women with incomplete abortion who underwent surgical versus pharmaceutical intervention were compared.
RESULTS
Among 589 spontaneous abortions, 198 were included in the study, of which 123 (62.1%) underwent surgical evacuation and 75 (37.9%) pharmaceutical intervention with misoprostol. Baseline characteristics were similar between groups. During 130.8 ± 91.7 days of follow-up, no patient who underwent surgical evacuation had retained products of conception or needed surgical hysteroscopy. Four cases (5.3%) in the misoprostol group had retained products of conception and needed hysteroscopy (p = 0.02). Patients who underwent surgical evacuation had higher hemoglobin levels during follow-up (12.1 mg/dL vs. 11.7 mg/dL, p = 0.05). There were no differences in post-treatment pregnancy rates between groups.
CONCLUSION
Long-term follow-up after incomplete abortion showed that hemodynamically stable patients treated with misoprostol achieved the desired results in 95% of cases without significant differences in pregnancy intervals compared to surgical management. Further prospective studies with larger sample sizes are required to confirm the outcomes described in this study.
Topics: Pregnancy; Humans; Female; Abortion, Spontaneous; Abortion, Incomplete; Misoprostol; Abortifacient Agents, Nonsteroidal; Prospective Studies; Retrospective Studies; Abortion, Induced; Pharmaceutical Preparations
PubMed: 37653249
DOI: 10.1007/s00404-023-07182-7 -
Obstetrical & Gynecological Survey Oct 2016Induction of labor is a widely used obstetric intervention, occurring in one in four pregnancies. When the cervix is unfavorable, still many different induction methods... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
Induction of labor is a widely used obstetric intervention, occurring in one in four pregnancies. When the cervix is unfavorable, still many different induction methods are used.
OBJECTIVE
We compared Foley catheter alone to different misoprostol dosages and administration routes, and the combination of Foley catheter with misoprostol.
EVIDENCE ACQUISITION
We reviewed the literature on the best induction method regarding their safety and effectiveness, using the outcome measures hyperstimulation, fetal distress, neonatal morbidity and mortality as well as cesarean delivery, vaginal instrumental delivery, and maternal morbidity. We searched Pubmed, Cochrane, and Web of Science from January 1, 1980 to February 12, 2016. Twenty-two randomized controlled trials (RCTs) were included, comparing Foley catheter with or without misoprostol to misoprostol alone (both vaginal and oral) for induction of labor (5,015 women).
RESULTS
Most included studies were underpowered to detect differences in safety outcomes, as the majority are powered for time to delivery or cesarean delivery. Meta-analysis of these studies does not allow assessment of the safety profile of Foley catheter compared to misoprostol (any dose, any administration route) with sufficient power. For the safety outcomes of the total group of Foley catheter versus misoprostol (any dose, any administration route) (17 studies, 4,234 women) we found that Foley catheter results in less hyperstimulation compared to misoprostol (2% versus 4%; risk ratio [RR], 0.54; 95% confidence interval [CI], 0.37-0.79) and fewer cesarean deliveries for nonreassuring fetal heart rate, 5% vs 7%; RR, 0.72; 95% CI, 0.55-0.95; while there were no statistically significant differences in neonatal outcomes. The total number of cesarean deliveries was 26% versus 22% (RR, 1.16; 95% CI, 1.00-1.34). There were fewer vaginal instrumental deliveries with a Foley catheter compared to misoprostol (10% vs 14%; RR, 0.74; 95% CI, 0.60-0.91). Foley catheter with misoprostol compared to misoprostol alone (any dose, any administration route) (7 studies, 1,073 women) resulted in less hyperstimulation than misoprostol alone (17% vs 23%; RR, 0.71; 95% CI, 0.52-0.97). Cesarean deliveries for nonreassuring fetal heart rate were comparable (7% vs 9%; RR, 0.79; 95% CI, 0.51-1.22). Neonatal outcomes were infrequently reported. The total number of cesarean deliveries was 34% versus 34% (RR, 1.01; 95% CI, 0.86-1.19).
CONCLUSION
In women with an unripe cervix at term, Foley catheter seems to have a better safety profile than misoprostol (any dose, any administration route) for induction of labor. Larger studies are needed to investigate the safety profile of a Foley catheter compared to separate dosing and administration regimens of misoprostol.
Topics: Catheterization; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Pregnancy Outcome; Risk Assessment
PubMed: 27770132
DOI: 10.1097/OGX.0000000000000361 -
Journal of Clinical Pharmacology Aug 2023This study aimed to evaluate the efficacy and safety of evening primrose oil (EPO) for cervical ripening before gynecologic procedures and compare it to misoprostol. In... (Randomized Controlled Trial)
Randomized Controlled Trial
This study aimed to evaluate the efficacy and safety of evening primrose oil (EPO) for cervical ripening before gynecologic procedures and compare it to misoprostol. In this study, 40 hysteroscopy and dilation and curettage candidates were enrolled. Patients were randomly assigned to receive either 2000 mg of vaginal EPO (n = 20) or 200 μg of vaginal misoprostol (n = 20) 2 hours before the expected procedure. The measured outcomes were the size of the Hegar dilator that passed through the cervix effortlessly, uterine cervicovaginal complications, and drug-related side effects. The two groups were not significantly different in age, number of gravity, parity, type of delivery, and menopausal status (P > .05). The mean ± SD size of the first dilator was 5.25 ± 1.55 in the misoprostol group and 7.30 ± 1.08 in the EPO group (P < .001). The pain complaint in the EPO group was significantly lower (P = .027), but the two groups were not significantly different in terms of other complications. No cases of uterine or cervical rupture were seen in either group. The present study showed that 2000 mg of vaginal EPO was significantly more effective for cervical ripening than 200 μg of vaginal misoprostol before gynecological surgery. Therefore, it is recommended to use EPO as an alternative to misoprostol.
Topics: Pregnancy; Humans; Female; Misoprostol; Cervix Uteri; Oxytocics; Gynecologic Surgical Procedures; Administration, Intravaginal
PubMed: 37102338
DOI: 10.1002/jcph.2253 -
Journal of Gynecology Obstetrics and... Jan 2022To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that examined the maternal and neonatal outcomes of misoprostol+isosorbide... (Meta-Analysis)
Meta-Analysis
Misoprostol plus isosorbide mononitrate versus misoprostol alone for cervical ripening during labor induction: A systematic review and meta-analysis of randomized controlled trials.
AIM
To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that examined the maternal and neonatal outcomes of misoprostol+isosorbide mononitrate (ISMN) versus misoprostol alone (control) in promoting cervical ripening during labor induction.
METHODS
We searched five databases from inception until 05-May-2021. We assessed risk of bias of RCTs, meta-analyzed 23 endpoints, and pooled them as mean difference or risk ratio with 95% confidence interval.
RESULTS
Overall, five RCTs met the inclusion criteria, comprising 850 patients (426 and 424 patients were allocated to misoprostol+ISMN and misoprostol group, respectively). Overall, the RCTs had a low risk of bias. Pertaining to maternal delivery-related outcomes, there was no significant difference between both groups regarding the mean interval from drug administration to delivery, rate of vaginal delivery, rate of cesarean section delivery, and rate of need for oxytocin augmentation. Pertaining to maternal drug-related side effects, the rate of maternal headache was significantly higher in disfavor of the misoprostol+ISMN compared with misoprostol alone. However, the rates of maternal nausea, hypotension, flushing, palpitation, dizziness, postpartum hemorrhage, and uterine tachysystole did not differ between both groups. Pertaining to neonatal outcomes, there was no significant difference between both groups regarding rates of NICU admission, meconium-stained amniotic fluid, and Apgar score <7 at five minutes.
CONCLUSION
Compared with misoprostol alone, co-administration of misoprostol+ISMN did not correlate with superior maternal delivery-related outcomes. The rate of maternal headache was significantly higher in disfavor of the misoprostol+ISMN group. There was no significant difference between both groups regarding neonatal endpoints.
Topics: Adult; Cervical Ripening; Female; Humans; Isosorbide; Labor, Induced; Misoprostol; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 34583026
DOI: 10.1016/j.jogoh.2021.102235 -
Clinical Pharmacology in Drug... Aug 2022Misoprostol is a synthetic prostaglandin E1 derivative that has been used to treat duodenal and gastric ulcers, and to prevent ulcers caused by nonsteroidal... (Randomized Controlled Trial)
Randomized Controlled Trial
Misoprostol is a synthetic prostaglandin E1 derivative that has been used to treat duodenal and gastric ulcers, and to prevent ulcers caused by nonsteroidal anti-inflammatory drugs in many countries. Misoprostol can also be used for medical abortion. This study aimed to investigate the pharmacokinetic profiles of misoprostol tablets (test product) by comparing them with Cytotec (200 μg) (reference product). To assess the bioequivalence between test and reference products, a two-sequence, two-period crossover study was conducted with 48 healthy Chinese subjects enrolled under fasting conditions. A validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay was used to determine the concentration of misoprostol acid in plasma. A mixed model analysis of variance was used to calculate the bioequivalence of pharmacokinetic (PK) parameters. The point estimate of geometric mean ratios with 90% confidence intervals for the maximum observed concentration (C ) and the area under the concentration-time curve (AUC ) for misoprostol acid in reference and test products were 107.8% and 106.5%, respectively (range 80%-125%). Additionally, none of the secondary PK parameters presented significant differences. No severe or more than moderate adverse events were detected in the 48 subjects. However, one subject discontinued the treatment due to drug-related gastrointestinal reactions. All adverse events were mild with rates of 19.2% and 22.9% after the administration test and reference products, respectively. Overall, the bioequivalence between the two misoprostol products was demonstrated in fasting conditions, and all subjects tolerated both treatments.
Topics: China; Chromatography, Liquid; Cross-Over Studies; Healthy Volunteers; Humans; Misoprostol; Tablets; Tandem Mass Spectrometry; Therapeutic Equivalency
PubMed: 35486088
DOI: 10.1002/cpdd.1102