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European Journal of Obstetrics,... Dec 2023To conduct the first-ever systematic review and meta-analysis of randomized controlled trials (RCTs) on the antihemorrhagic utility and safety of tranexamic acid (TXA)... (Meta-Analysis)
Meta-Analysis Review
AIM
To conduct the first-ever systematic review and meta-analysis of randomized controlled trials (RCTs) on the antihemorrhagic utility and safety of tranexamic acid (TXA) versus misoprostol for management (prevention and/or treatment) of postpartum hemorrhage (PPH).
METHODS
Six databases were screened from inception until May 2023 and updated in September 2023. The RCTs were assessed for quality according to the Cochrane's risk of bias tool. The endpoints were summarized as mean difference (MD) or risk ratio (RR) with 95% confidence interval (CI) in a random-effects model.
RESULTS
Ten RCTs with 2121 patients (TXA = 1061 and misoprostol = 1060) were analyzed. There was no significant difference between TXA and misoprostol groups regarding the mean intraoperative blood loss (n = 9 RCTs, MD = 17.32 ml, 95% CI [-40.43, 75.07], p = 0.56), mean change in hemoglobin (n = 6 RCTs, MD = 0.11 mg/dl, 95% CI [-0.1, 0.31], p = 0.30), mean hospital stay (n = 2 RCTs, MD = -0.3 day, 95% CI [-0.61, 0.01], p = 0.06), blood transfusion rate (n = 4 RCTs, RR = 0.49, 95% CI [0.16, 1.47], p = 0.2), and rate of additional uterotonic agents (n = 4 RCTs, RR = 1.05, 95% CI [0.72, 1.53], p = 0.81). Leave-one-out sensitivity analysis showed robustness of the results, and there was no evidence of publication bias. Regarding safety endpoints, there was no significant difference between both groups regarding the rates of minor side effects, such as diarrhea, fever, nausea, and vomiting. No patient developed thromboembolic events in the TXA group.
CONCLUSION
There was no significant antihemorrhagic efficacy between adjunct TXA and misoprostol for the management of PPH. The safety profile was comparable between both agents.
Topics: Pregnancy; Female; Humans; Misoprostol; Postpartum Hemorrhage; Tranexamic Acid; Randomized Controlled Trials as Topic; Hemostatics; Blood Loss, Surgical; Antifibrinolytic Agents
PubMed: 37832480
DOI: 10.1016/j.ejogrb.2023.10.006 -
American Journal of Obstetrics and... Mar 2024Several systematic reviews and meta-analyses have summarized the evidence on the efficacy and safety of various outpatient cervical ripening methods. However, the method... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Several systematic reviews and meta-analyses have summarized the evidence on the efficacy and safety of various outpatient cervical ripening methods. However, the method with the highest efficacy and safety profile has not been determined conclusively. We performed a systematic review and network meta-analysis of published randomized controlled trials to assess the efficacy and safety of cervical ripening methods currently employed in the outpatient setting.
DATA SOURCES
With the assistance of an experienced medical librarian, we performed a systematic search of the literature using MEDLINE, Embase, Scopus, Web of Science, Cochrane Library, and ClinicalTrials.gov. We systematically searched electronic databases from inception to January 14, 2020.
STUDY ELIGIBILITY CRITERIA
We considered randomized controlled trials comparing a variety of methods for outpatient cervical ripening.
METHODS
We conducted a frequentist random effects network meta-analysis employing data from randomized controlled trials. We performed a direct, pairwise meta-analysis to compare the efficacy of various outpatient cervical ripening methods, including placebo. We employed ranking strategies to determine the most efficacious method using the surface under the cumulative ranking curve; a higher surface under the cumulative ranking curve value implied a more efficacious method. We assessed the following outcomes: time from intervention to delivery, cesarean delivery rates, changes in the Bishop score, need for additional ripening methods, incidence of Apgar scores <7 at 5 minutes, and uterine hyperstimulation.
RESULTS
We included data from 42 randomized controlled trials including 6093 participants. When assessing the efficacy of all methods, 25 μg vaginal misoprostol was the most efficacious in reducing the time from intervention to delivery (surface under the cumulative ranking curve of 1.0) without increasing the odds of cesarean delivery, the need for additional ripening methods, the incidence of a low Apgar score, or uterine hyperstimulation. Acupressure (surface under the cumulative ranking curve of 0.3) and primrose oil (surface under the cumulative ranking curve of 0.2) were the least effective methods in reducing the time to delivery interval. Among effective methods, 50 mg oral mifepristone was associated with the lowest odds of cesarean delivery (surface under the cumulative ranking curve of 0.9).
CONCLUSION
When balancing efficacy and safety, vaginal misoprostol 25 μg represents the best method for outpatient cervical ripening.
Topics: Pregnancy; Female; Humans; Misoprostol; Oxytocics; Cervical Ripening; Network Meta-Analysis; Outpatients; Labor, Induced
PubMed: 38462254
DOI: 10.1016/j.ajog.2022.09.043 -
International Journal of Molecular... Jan 2024This systematic review and meta-analysis evaluated the efficacy of dexlansoprazole (a proton pump inhibitor-PPI) in resolving heartburn, reflux, and other symptoms and... (Meta-Analysis)
Meta-Analysis Review
This systematic review and meta-analysis evaluated the efficacy of dexlansoprazole (a proton pump inhibitor-PPI) in resolving heartburn, reflux, and other symptoms and complications resulting from gastroesophageal reflux disease (GERD). The study followed PRISMA 2020 and was registered in PROSPERO (CRD42020206513). The search strategy used MeSH and free terms appropriately adapted for each database. Only randomized clinical trials (RCTs) were included. The Cochrane tool (RoB 2.0) was used to assess the risk of bias, and the certainty of evidence was rated using GRADE. Ten RCTs were included. Dexlansoprazole outperformed the placebo and other PPIs in the resolution of heartburn and reflux symptoms in patients with GERD, with benefits during and after treatment, especially in those with moderate and severe symptoms. The meta-analyses indicated that dexlansoprazole at doses of 30 and 60 mg had more 24 h heartburn-free days and nights compared to the placebo medications; no difference was reported between dexlansoprazole at doses of 30 and 60 mg in heartburn-free nights. A low bias risk and a moderate certainty of evidence were observed. This review confirms the therapeutic effect of dexlansoprazole (placebo-controlled) and its improvements in GERD symptoms compared to another PPI. However, the interpretation of the results should be carried out cautiously due to the small number of included studies and other reported limitations.
Topics: Humans; Dexlansoprazole; Gastroesophageal Reflux; Heartburn; Proton Pump Inhibitors; Treatment Outcome
PubMed: 38279248
DOI: 10.3390/ijms25021247 -
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 -
Antibiotics (Basel, Switzerland) Jul 2023Bacterial infections have attracted the attention of researchers in recent decades, especially due to the special problems they have faced, such as their increasing... (Review)
Review
Bacterial infections have attracted the attention of researchers in recent decades, especially due to the special problems they have faced, such as their increasing diversity and resistance to antibiotic treatment. The emergence and development of the SARS-CoV-2 infection stimulated even more research to find new structures with antimicrobial and antiviral properties. Among the heterocyclic compounds with remarkable therapeutic properties, benzimidazoles, and triazoles stand out, possessing antimicrobial, antiviral, antitumor, anti-Alzheimer, anti-inflammatory, analgesic, antidiabetic, or anti-ulcer activities. In addition, the literature of the last decade reports benzimidazole-triazole hybrids with improved biological properties compared to the properties of simple mono-heterocyclic compounds. This review aims to provide an update on the synthesis methods of these hybrids, along with their antimicrobial and antiviral activities, as well as the structure-activity relationship reported in the literature. It was found that the presence of certain groups grafted onto the benzimidazole and/or triazole nuclei (-F, -Cl, -Br, -CF, -NO, -CN, -CHO, -OH, OCH, COOCH), as well as the presence of some heterocycles (pyridine, pyrimidine, thiazole, indole, isoxazole, thiadiazole, coumarin) increases the antimicrobial activity of benzimidazole-triazole hybrids. Also, the presence of the oxygen or sulfur atom in the bridge connecting the benzimidazole and triazole rings generally increases the antimicrobial activity of the hybrids. The literature mentions only benzimidazole-1,2,3-triazole hybrids with antiviral properties. Both for antimicrobial and antiviral hybrids, the presence of an additional triazole ring increases their biological activity, which is in agreement with the three-dimensional binding mode of compounds. This review summarizes the advances of benzimidazole triazole derivatives as potential antimicrobial and antiviral agents covering articles published from 2000 to 2023.
PubMed: 37508316
DOI: 10.3390/antibiotics12071220 -
European Journal of Obstetrics,... Jan 2024A large number of randomized controlled trials (RCTs) have been published on the effects of oral/vaginal misoprostol and oxytocin on delivery outcomes; however, data... (Meta-Analysis)
Meta-Analysis Review
Effect of misoprostol versus oxytocin on delivery outcomes after labour induction in pregnant women: A systematic review and meta-analysis of randomized controlled trials.
A large number of randomized controlled trials (RCTs) have been published on the effects of oral/vaginal misoprostol and oxytocin on delivery outcomes; however, data from these RCTs are conflicting. Although some meta-analyses summarized available findings in this regard, several eligible RCTs have been published since the release of those meta-analyses. Therefore, the current updated systematic review and meta-analysis of RCTs was conducted to compare the effects of oral/vaginal misoprostol and oxytocin on delivery and neonatal outcomes. A systematic search, using relevant keywords, was done in the online databases of PubMed/Medline, Scopus, and ISI Web of Science, up to April 2023, to identify eligible articles investigating the effect of oral/vaginal misoprostol and oxytocin on delivery outcomes including maternal [cesarean/vaginal delivery within 24 h after labour induction, Tachysystole, hypertonicity, hyper-stimulation, postpartum hemorrhage (PPH)] and neonatal outcomes [mean Apgar score, admission to neonatal intensive care unit (NICU), and death]. In total, 45 RCTs with a total sample size of 8406 participants were included. Meta-analysis revealed that vaginal misoprostol administration, compared with oxytocin, resulted in a significant reduction in the rate of cesarean and a significant increase in the rate of vaginal delivery and Tachysystole risk. Also, oral misoprostol was associated with a significant reduction in the rate of cesarean and a significant increase in the risk of hypertonicity compared with oxytocin. However, oral misoprostol had no significant effect on vaginal delivery compared with oxytocin. For other outcomes including hyper-stimulation, perinatal death, NICU admission, and mean Apgar score among newborns, we found no significant difference between oral/vaginal misoprostol and oxytocin. In total, vaginal/oral misoprostol might be a better method for labour induction compared with oxytocin. PROSPERO registration: CRD42023412325.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Misoprostol; Oxytocin; Oxytocics; Pregnant Women; Randomized Controlled Trials as Topic; Labor, Induced; Administration, Intravaginal
PubMed: 37976769
DOI: 10.1016/j.ejogrb.2023.11.006 -
The Cochrane Database of Systematic... Nov 2023Postpartum haemorrhage (PPH), defined as blood loss of 500 mL or more after childbirth, is the leading cause of maternal mortality worldwide. It is possible to prevent... (Review)
Review
BACKGROUND
Postpartum haemorrhage (PPH), defined as blood loss of 500 mL or more after childbirth, is the leading cause of maternal mortality worldwide. It is possible to prevent complications of PPH with timely and appropriate detection and management. However, implementing the best methods of PPH prevention, detection and management can be challenging, particularly in low- and middle-income countries.
OBJECTIVES
Our overall objective was to explore the perceptions and experiences of women, community members, lay health workers, and skilled healthcare providers who have experience with PPH or with preventing, detecting, and managing PPH, in community or health facility settings.
SEARCH METHODS
We searched MEDLINE, CINAHL, Scopus, and grey literature on 13 November 2022 with no language restrictions. We then performed reference checking and forward citation searching of the included studies.
SELECTION CRITERIA
We included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that explored perceptions and experiences of PPH prevention, detection, and management among women, community members, traditional birth attendants, healthcare providers, and managers.
DATA COLLECTION AND ANALYSIS
We used three-stage maximum variation sampling to ensure diversity in terms of relevance of the study to the review objectives, richness of data, and coverage of critical contextual elements: setting (region, country income level), perspective (type of participant), and topic (prevention, detection, management). We extracted data using a data extraction form designed for this review. We used thematic synthesis to analyse and synthesise the evidence, and we used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. To identify factors that may influence intervention implementation, we mapped each review finding to the Theoretical Domains Framework (TDF) and the Capability, Motivation, and Opportunity model of Behaviour change (COM-B). We used the Behaviour Change Wheel to explore implications for practice.
MAIN RESULTS
We included 67 studies and sampled 43 studies for our analysis. Most were from low- or middle-income countries (33 studies), and most included the perspectives of women and health workers. We downgraded our confidence in several findings from high confidence to moderate, low, or very-low confidence, mainly due to concerns about how the studies were conducted (methodological limitations) or concerns about missing important perspectives from some types of participants or in some settings (relevance). In many communities, bleeding during and after childbirth is considered "normal" and necessary to expel "impurities" and restore and cleanse the woman's body after pregnancy and birth (moderate confidence). In some communities, people have misconceptions about causes of PPH or believe that PPH is caused by supernatural powers or evil spirits that punish women for ignoring or disobeying social rules or for past mistakes (high confidence). For women who give birth at home or in the community, female family members or traditional birth attendants are the first to recognise excess bleeding after birth (high confidence). Family members typically take the decision of whether and when to seek care if PPH is suspected, and these family members are often influenced by trusted traditional birth attendants or community midwives (high confidence). If PPH is identified for women birthing at home or in the community, decision-making about the subsequent referral and care pathway can be multifaceted and complex (high confidence). First responders to PPH are not always skilled or trained healthcare providers (high confidence). In health facilities, midwives may consider it easy to implement visual estimation of blood loss with a kidney dish or under-pad, but difficult to accurately interpret the amount of blood loss (very low confidence). Quantifying (rather than estimating) blood loss may be a complex and contentious change of practice for health workers (low confidence). Women who gave birth in health facilities and experienced PPH described it as painful, embarrassing, and traumatic. Partners or other family members also found the experience stressful. While some women were dissatisfied with their level of involvement in decision-making for PPH management, others felt health workers were best placed to make decisions (moderate confidence). Inconsistent availability of resources (drugs, medical supplies, blood) causes delays in the timely management of PPH (high confidence). There is limited availability of misoprostol in the community owing to stockouts, poor supply systems, and the difficulty of navigating misoprostol procurement for community health workers (moderate confidence). Health workers described working on the maternity ward as stressful and intense due to short staffing, long shifts, and the unpredictability of emergencies. Exhausted and overwhelmed staff may be unable to appropriately monitor all women, particularly when multiple women are giving birth simultaneously or on the floor of the health facility; this could lead to delays in detecting PPH (moderate confidence). Inadequate staffing, high turnover of skilled health workers, and appointment of lower-level cadres of health workers are key challenges to the provision of quality PPH care (high confidence). Through team-based simulation training, health workers of different cadres (doctors, midwives, lay health workers) can develop a shared mental model to help them work quickly, efficiently, and amicably as a team when managing women with PPH (moderate confidence).
AUTHORS' CONCLUSIONS
Our findings highlight how improving PPH prevention, detection, and management is underpinned by a complex system of interacting roles and behaviours (community, women, health workers of different types and with different experiences). Multiple individual, sociocultural, and environmental factors influence the decisions and behaviours of women, families, communities, health workers, and managers. It is crucial to consider the broader health and social systems when designing and implementing PPH interventions to change or influence these behaviours. We have developed a set of prompts that may help programme managers, policymakers, researchers, and other key stakeholders to identify and address factors that affect implementation and scale-up of interventions to improve PPH prevention, detection, and management.
Topics: Pregnancy; Female; Humans; Postpartum Hemorrhage; Misoprostol; Health Personnel; Midwifery; Family
PubMed: 38009552
DOI: 10.1002/14651858.CD013795.pub2 -
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 -
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 -
American Journal of Obstetrics and... Mar 2024Several systematic reviews and meta-analyses have been conducted to summarize the evidence for the efficacy of various labor induction agents. However, the most... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Several systematic reviews and meta-analyses have been conducted to summarize the evidence for the efficacy of various labor induction agents. However, the most effective agents or strategies have not been conclusively determined. We aimed to perform a meta-review and network meta-analysis of published systematic reviews to determine the efficacy and safety of currently employed pharmacologic, mechanical, and combined methods of labor induction.
DATA SOURCES
With the assistance of an experienced medical librarian, we performed a systematic search of the literature using PubMed, EMBASE, and the Cochrane Central Register of Control Trials. We systematically searched electronic databases from inception to May 31, 2021.
STUDY ELIGIBILITY CRITERIA
We considered systematic reviews and meta-analyses of randomized controlled trials comparing different agents or methods for inpatient labor induction.
METHODS
We conducted a frequentist random-effects network meta-analysis employing data from randomized controlled trials of published systematic reviews. We performed direct pairwise meta-analyses to compare the efficacy of the various labor induction agents and placebo or no treatment. We performed ranking to determine the best treatment using the surface under the cumulative ranking curve. The main outcomes assessed were cesarean delivery, vaginal delivery within 24 hours, operative vaginal delivery, hyperstimulation, neonatal intensive care unit admissions, and Apgar scores of <7 at 5 minutes of birth.
RESULTS
We included 11 systematic reviews and extracted data from 207 randomized controlled trials with a total of 40,854 participants. When assessing the efficacy of all agents and methods, the combination of a single-balloon catheter with misoprostol was the most effective in reducing the odds of cesarean delivery and vaginal birth >24 hours (surface under the cumulative ranking curve of 0.9 for each). Among the pharmacologic agents, low-dose vaginal misoprostol was the most effective in reducing the odds of cesarean delivery, whereas high-dose vaginal misoprostol was the most effective in achieving vaginal delivery within 24 hours (surface under the cumulative ranking curve of 0.9 for each). Single-balloon catheter (surface under the cumulative ranking curve of 0.8) and double-balloon catheter (surface under the cumulative ranking curve of 0.9) were the most effective in reducing the odds of operative vaginal delivery and hyperstimulation. Buccal or sublingual misoprostol (surface under the cumulative ranking curve of 0.9) and the combination of single-balloon catheter and misoprostol (surface under the cumulative ranking curve of 0.9) most effectively reduced the odds of abnormal Apgar scores and neonatal intensive care unit admissions.
CONCLUSION
The combination of a single-balloon catheter with misoprostol was the most effective method in reducing the odds for cesarean delivery and prolonged time to vaginal delivery. This method was associated with a reduction in admissions to the neonatal intensive care unit.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Misoprostol; Oxytocics; Network Meta-Analysis; Labor, Induced; Urinary Catheters
PubMed: 38462253
DOI: 10.1016/j.ajog.2022.01.005