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American Journal of Perinatology May 2024This study aimed to conduct a systematic review and meta-analysis of all randomized and nonrandomized controlled trials (RCTs and NCTs, respectively) that explored... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This study aimed to conduct a systematic review and meta-analysis of all randomized and nonrandomized controlled trials (RCTs and NCTs, respectively) that explored the maternal-neonatal outcomes of cervical osmotic dilators versus dinoprostone in promoting cervical ripening during labor induction.
STUDY DESIGN
Six major databases were screened until August 27, 2022. The quality of included studies was evaluated. The data were summarized as mean difference or risk ratio (RR) with 95% confidence interval (CI) in a random-effects model.
RESULTS
Overall, 14 studies with 15 arms were analyzed ( = 2,380 patients). Ten and four studies were RCTs and NCTs, respectively. The overall quality for RCTs varied (low risk = 2, unclear risk = 7, and high risk = 1), whereas all NCTs had good quality ( = 4). For the primary endpoints, there was no significant difference between both groups regarding the rate of normal vaginal delivery (RR = 1.04, 95% CI: 0.95-1.14, = 0.41) and rate of cesarean delivery (RR = 1.04, 95% CI: 0.93-1.17, = 0.51). Additionally, there was no significant difference between both groups regarding the mean change in Bishop score and mean time from intervention to delivery. The rate of uterine hyperstimulation was significantly lower in the cervical osmotic dilator group. For the neonatal outcomes, during cervical ripening, the rate of fetal distress was significantly lower in the cervical osmotic dilator group. There was no significant difference between both groups regarding the mean Apgar scores, rate of meconium-stained amniotic fluid, rate of umbilical cord metabolic acidosis, rate of neonatal infection, and rate of neonatal intensive care unit admission.
CONCLUSION
During labor induction, cervical ripening with cervical osmotic dilators and dinoprostone had comparable maternal-neonatal outcomes. Cervical osmotic dilators had low risk of uterine hyperstimulation compared with dinoprostone. Overall, cervical osmotic dilators might be more preferred over dinoprostone in view of their analogous cervical ripening effects, comparable maternal-neonatal outcomes, and lack of drug-related adverse events.
KEY POINTS
· This is the first analysis of cervical osmotic dilators versus PGE2 for cervical ripening during labor.. · There was no difference between both arms regarding the rates of normal vaginal/cesarean deliveries.. · There was no difference between both arms regarding the rates of neonatal adverse events.. · Cervical osmotic dilators had significant lower risk of uterine hyperstimulation compared with PGE2.. · Cervical osmotic dilators may be superior to PGE2 in view of their similar efficacy and better safety..
Topics: Humans; Labor, Induced; Cervical Ripening; Pregnancy; Female; Dinoprostone; Oxytocics; Cesarean Section; Infant, Newborn; Randomized Controlled Trials as Topic; Cervix Uteri; Delivery, Obstetric
PubMed: 37336231
DOI: 10.1055/s-0043-1770161 -
Journal of Dermatological Science Apr 2018Primary hypertrophic osteoarthropathy (PHO), also known as pachydermoperiostosis is a rare genetic disease which predominantly affects skin, bone and soft connective... (Review)
Review
BACKGROUND
Primary hypertrophic osteoarthropathy (PHO), also known as pachydermoperiostosis is a rare genetic disease which predominantly affects skin, bone and soft connective tissue. It is characterized by the triad of pachydermia, digital clubbing and periostosis of long bones. Arthralgia or arthritis is also present in most of the cases. Genetic studies have identified the impaired PGE2 metabolism as a culprit for hypertrophic osteoarthropathy in PHO cases. We conducted a systematic review to examine the effectiveness of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), a PGE2 synthesis blocker to reduce the symptoms among PHO patients.
METHODS
We searched the evidence in five databases; Cochrane Library, CINAHL, EMBASE, MEDLINE, and PubMed. We reported the evidence using narrative synthesis.
RESULTS
Out of 238 identified studies, we selected 26 for the synthesis. All were case reports which included a total of 54 patients. Among them, 39 patients were treated with at least one type of NSAIDs. Around 70% of the patients treated with NSAIDs had clinical improvement for their symptoms, mostly arthritis or arthralgia symptoms.
CONCLUSION
NSAIDs were effective in improving arthralgia or arthritis symptoms in majority of the PHO patients. Therefore, we recommend the use of NSAIDs in PHO patients to treat arthralgia or arthritis.
Topics: Cyclooxygenase Inhibitors; Dinoprostone; Humans; Osteoarthropathy, Primary Hypertrophic; Rare Diseases; Treatment Outcome
PubMed: 29305259
DOI: 10.1016/j.jdermsci.2017.12.012 -
BJOG : An International Journal of... May 2017Induction of labour has become an increasingly common procedure. Ripening methods, including mechanical devices and pharmacological agents, improve the success rate of... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
Induction of labour has become an increasingly common procedure. Ripening methods, including mechanical devices and pharmacological agents, improve the success rate of labour induction.
OBJECTIVE
To compare the efficacy and safety of the double-balloon catheter with prostaglandin E2 agents used for labour induction.
SEARCH STRATEGY
We searched electronic sources from MEDLINE, Embase and Web of Science, the Cochrane Library Database of Systematic Reviews, and ClinicalTrials.gov website.
SELECTION CRITERIA
Only randomised controlled trials comparing the PGE2 agents with the double-balloon catheter for cervical ripening and labour induction in women with unfavourable cervices were included in the analysis.
DATA COLLECTION AND ANALYSIS
The main outcomes included the vaginal delivery rate within 24 hours and risk of caesarean section. We calculated relative risks and mean differences using fixed- and random-effects models.
MAIN RESULTS
Nine studies (1866 patients) were included in this systematic review. Both the double-balloon catheter and PGE2 agents were comparable with regard to rate of caesarean section (RR 0.92; 95% CI 0.79, 1.07), vaginal delivery within 24 hours (RR 0.95; 95% CI 0.78, 1.16) and maternal adverse events, but the risk of excessive uterine activity (RR 10.02; 95% CI 3.99, 25.17) and need for neonatal intensive care unit admissions (RR 1.31; 95% CI 1.01, 1.69) were significantly increased in women who received PGE2 agents.
CONCLUSIONS
The double-balloon catheter demonstrated greater safety and cost-effectiveness than PGE2 agents for cervical ripening and labour induction. The efficacy profiles of both methods were similar.
TWEETABLE ABSTRACT
Double-balloon catheter versus prostaglandin E2 for cervical ripening and labour induction.
Topics: Adult; Catheters; Cervical Ripening; Delivery, Obstetric; Dinoprostone; Female; Humans; Labor, Induced; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 27533177
DOI: 10.1111/1471-0528.14256 -
The Cochrane Database of Systematic... Sep 2017Induction of labour is carried out for a variety of indications and using a range of methods. For women at low risk of pregnancy complications, some methods of induction... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Induction of labour is carried out for a variety of indications and using a range of methods. For women at low risk of pregnancy complications, some methods of induction of labour or cervical ripening may be suitable for use in outpatient settings.
OBJECTIVES
To examine pharmacological and mechanical interventions to induce labour or ripen the cervix in outpatient settings in terms of effectiveness, maternal satisfaction, healthcare costs and, where information is available, safety.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised controlled trials examining outpatient cervical ripening or induction of labour with pharmacological agents or mechanical methods. Cluster trials were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed evidence using the GRADE approach.
MAIN RESULTS
This updated review included 34 studies of 11 different methods for labour induction with 5003 randomised women, where women received treatment at home or were sent home after initial treatment and monitoring in hospital.Studies examined vaginal and intracervical prostaglandin E₂ (PGE₂), vaginal and oral misoprostol, isosorbide mononitrate, mifepristone, oestrogens, amniotomy and acupuncture, compared with placebo, no treatment, or routine care. Trials generally recruited healthy women with a term pregnancy. The risk of bias was mostly low or unclear, however, in 16 trials blinding was unclear or not attempted. In general, limited data were available on the review's main and additional outcomes. Evidence was graded low to moderate quality. 1. Vaginal PGE₂ versus expectant management or placebo (5 studies)Fewer women in the vaginal PGE₂ group needed additional induction agents to induce labour, however, confidence intervals were wide (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.27 to 0.99; 150 women; 2 trials). There were no clear differences between groups in uterine hyperstimulation (with or without fetal heart rate (FHR) changes) (RR 3.76, 95% CI 0.64 to 22.24; 244 women; 4 studies; low-quality evidence), caesarean section (RR 0.80, 95% CI 0.49 to 1.31; 288 women; 4 studies; low-quality evidence), or admission to a neonatal intensive care unit (NICU) (RR 0.32, 95% CI 0.10 to 1.03; 230 infants; 3 studies; low-quality evidence).There was no information on vaginal birth within 24, 48 or 72 hours, length of hospital stay, use of emergency services or maternal or caregiver satisfaction. Serious maternal and neonatal morbidity or deaths were not reported. 2. Intracervical PGE₂ versus expectant management or placebo (7 studies) There was no clear difference between women receiving intracervical PGE₂ and no treatment or placebo in terms of need for additional induction agents (RR 0.98, 95% CI 0.74 to 1.32; 445 women; 3 studies), vaginal birth not achieved within 48 to 72 hours (RR 0.83, 95% CI 0.68 to 1.02; 43 women; 1 study; low-quality evidence), uterine hyperstimulation (with FHR changes) (RR 2.66, 95% CI 0.63 to 11.25; 488 women; 4 studies; low-quality evidence), caesarean section (RR 0.90, 95% CI 0.72 to 1.12; 674 women; 7 studies; moderate-quality evidence), or babies admitted to NICU (RR 1.61, 95% CI 0.43 to 6.05; 215 infants; 3 studies; low-quality evidence). There were no uterine ruptures in either the PGE₂ group or placebo group.There was no information on vaginal birth not achieved within 24 hours, length of hospital stay, use of emergency services, mother or caregiver satisfaction, or serious morbidity or neonatal morbidity or perinatal death. 3. Vaginal misoprostol versus placebo (4 studies)One small study reported on the rate of perinatal death with no clear differences between groups; there were no deaths in the treatment group compared with one stillbirth (reason not reported) in the control group (RR 0.34, 95% CI 0.01 to 8.14; 77 infants; 1 study; low-quality evidence).There was no clear difference between groups in rates of uterine hyperstimulation with FHR changes (RR 1.97, 95% CI 0.43 to 9.00; 265 women; 3 studies; low-quality evidence), caesarean section (RR 0.94, 95% CI 0.61 to 1.46; 325 women; 4 studies; low-quality evidence), and babies admitted to NICU (RR 0.89, 95% CI 0.54 to 1.47; 325 infants; 4 studies; low-quality evidence).There was no information on vaginal birth not achieved within 24, 48 or 72 hours, additional induction agents required, length of hospital stay, use of emergency services, mother or caregiver satisfaction, serious maternal, and other neonatal, morbidity or death.No substantive differences were found for other comparisons. One small study found that women who received oral misoprostol were more likely to give birth within 24 hours (RR 0.65, 95% CI 0.48 to 0.86; 87 women; 1 study) and were less likely to require additional induction agents (RR 0.60, 95% CI 0.37 to 0.97; 127 women; 2 studies). Women who received mifepristone were also less likely to require additional induction agents (average RR 0.59, 95% CI 0.37 to 0.95; 311 women; 4 studies; I² = 74%); however, this result should be interpreted with caution due to high heterogeneity. One trial each of acupuncture and outpatient amniotomy were included, but few review outcomes were reported.
AUTHORS' CONCLUSIONS
Induction of labour in outpatient settings appears feasible and important adverse events seem rare, however, in general there is insufficient evidence to detect differences. There was no strong evidence that agents used to induce labour in outpatient settings had an impact (positive or negative) on maternal or neonatal health. There was some evidence that compared to placebo or no treatment, induction agents administered on an outpatient basis reduced the need for further interventions to induce labour, and shortened the interval from intervention to birth.We do not have sufficient evidence to know which induction methods are preferred by women, the interventions that are most effective and safe to use in outpatient settings, or their cost effectiveness. Further studies where various women-friendly outpatient protocols are compared head-to-head are required. As part of such work, women should be consulted on what sort of management they would prefer.
Topics: Acupuncture Therapy; Ambulatory Care; Cesarean Section; Dinoprostone; Feasibility Studies; Female; Humans; Intensive Care, Neonatal; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 28901007
DOI: 10.1002/14651858.CD007701.pub3 -
American Journal of Obstetrics and... Aug 2016The aim of this systematic review and metaanalysis was to determine the efficacy and safety of cervical ripening agents in the second trimester of pregnancy in patients... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The aim of this systematic review and metaanalysis was to determine the efficacy and safety of cervical ripening agents in the second trimester of pregnancy in patients with previous cesarean delivery.
STUDY DESIGN
Data sources were PubMed, EMBASE, CINAHL, LILACS, Google Scholar, and clinicaltrials.gov (1983 through 2015). Eligibility criteria were cohort or cross-sectional studies that reported on efficacy and safety of cervical ripening agents in patients with previous cesarean delivery. Efficacy was determined based on the proportion of patients achieving vaginal delivery and vaginal delivery within 24 hours following administration of a cervical ripening agent. Safety was assessed by the risk of uterine rupture and complications such as retained placental products, blood transfusion requirement, and endometritis, when available, as secondary outcomes. Of the 176 studies identified, 38 met the inclusion criteria. Of these, 17 studies were descriptive and 21 studies compared the efficacy and safety of cervical ripening agents between patients with previous cesarean and those with no previous cesarean. From included studies, we abstracted data on cervical ripening agents and estimated the pooled risk differences and risk ratios with 95% confidence intervals. To account for between-study heterogeneity, we estimated risk ratios based on underlying random effects analyses. Publication bias was assessed via funnel plots and across-study heterogeneity was assessed based on the I(2) measure.
RESULTS
The most commonly used agent was PGE1. In descriptive studies, PGE1 was associated with a vaginal delivery rate of 96.8%, of which 76.3% occurred within 24 hours, uterine rupture in 0.8%, retained placenta in 10.8%, and endometritis in 3.9% in patients with ≥1 cesarean. In comparative studies, the use of PGE1, PGE2, and mechanical methods (laminaria and dilation and curettage) were equally efficacious in achieving vaginal delivery between patients with and without prior cesarean (risk ratio, 0.99, and 95% confidence interval, 0.98-1.00; risk ratio, 1.00, and 95% confidence interval, 0.98-1.02; and risk ratio, 1.00, and 95% confidence interval, 0.98-1.01; respectively). In patients with history of ≥1 cesarean the use of PGE1 was associated with higher risk of uterine rupture (risk ratio, 6.57; 95% confidence interval, 2.21-19.52) and retained placenta (risk ratio, 1.21; 95% confidence interval, 1.03-1.43) compared to women without a prior cesarean. However, the risk of uterine rupture among women with history of only 1 cesarean (0.47%) was not statistically significant (risk ratio, 2.36; 95% confidence interval, 0.39-14.32), whereas among those with history of ≥2 cesareans (2.5%) was increased as compared to those with no previous cesarean (0.08%) (risk ratio, 17.55; 95% confidence interval, 3.00-102.8). Funnel plots did not demonstrate any clear evidence of publication bias. Across-study heterogeneity ranged from 0-81%.
CONCLUSION
This systematic review and metaanalysis provides evidence that PGE1, PGE2, and mechanical methods are efficacious for achieving vaginal delivery in women with previous cesarean delivery. The use of prostaglandin PGE1 in the second trimester was not associated with significantly increased risk for uterine rupture among women with only 1 cesarean; however, this risk was substantially increased among women with ≥2 cesareans although the absolute risk appeared to be relatively small.
Topics: Administration, Intravaginal; Alprostadil; Cervical Ripening; Cesarean Section; Female; Humans; Labor, Induced; Pregnancy; Pregnancy Trimester, Second
PubMed: 27018469
DOI: 10.1016/j.ajog.2016.03.037 -
The Cochrane Database of Systematic... Jun 2017Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is... (Review)
Review
BACKGROUND
Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013.
OBJECTIVES
To assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy.
MAIN RESULTS
Eight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns. Vaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported. Vaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported. Foley catheter versus intravenous oxytocin (one trial, subgroup of 53 women): no clear difference between groups for vaginal delivery not achieved within 24 hours (RR 1.47, 95% CI 0.89 to 2.44, evidence graded low), uterine hyperstimulation with fetal heart rate changes (RR 3.11, 95% CI 0.13 to 73.09, evidence graded low), and caesarean section (RR 0.93, 95% CI 0.45 to 1.92, evidence graded low). There were also no clear differences between groups for the reported secondary outcomes. The following GRADE outcomes were not reported: serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Double-balloon catheter versus vaginal PGE2 (one trial, subgroup of 26 women): no clear difference in caesarean section (RR 0.97, 95% CI 0.41 to 2.32, evidence graded very low). Vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death were not reported. Oral mifepristone versus Foley catheter (one trial, 107 women): no primary/GRADE outcomes were reported. Fewer women induced with mifepristone required oxytocin augmentation (RR 0.54, 95% CI 0.38 to 0.76). There were slightly fewer cases of uterine rupture among women who received mifepristone, however this was not a clear difference between groups (RR 0.29, 95% CI 0.08 to 1.02). No other secondary outcomes were reported. Vaginal isosorbide mononitrate (IMN) versus Foley catheter (one trial, 80 women): fewer women induced with IMN achieved a vaginal delivery within 24 hours (RR 2.62, 95% CI 1.32 to 5.21, evidence graded low). There was no difference between groups in the number of women who had a caesarean section (RR 1.00, 95% CI 0.39 to 2.59, evidence graded very low). More women induced with IMN required oxytocin augmentation (RR 1.65, 95% CI 1.17 to 2.32). There were no clear differences in the other reported secondary outcomes. The following GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. 80 mL versus 30 mL Foley catheter (one trial, 154 women): no clear difference between groups for the primary outcomes: vaginal delivery not achieved within 24 hours (RR 1.05, 95% CI 0.91 to 1.20, evidence graded moderate) and caesarean section (RR 1.05, 95% CI 0.89 to 1.24, evidence graded moderate). However, more women induced using a 30 mL Foley catheter required oxytocin augmentation (RR 0.81, 95% CI 0.66 to 0.98). There were no clear differences between groups for other secondary outcomes reported. Several GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Vaginal PGE2 pessary versus vaginal PGE2 tablet (one trial, 200 women): no difference between groups for caesarean section (RR 1.09, 95% CI 0.74 to 1.60, evidence graded very low), or any of the reported secondary outcomes. Several GRADE outcomes were not reported: vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.
AUTHORS' CONCLUSIONS
RCT evidence on methods of induction of labour for women with a prior caesarean section is inadequate, and studies are underpowered to detect clinically relevant differences for many outcomes. Several studies reported few of our prespecified outcomes and reporting of infant outcomes was especially scarce. The GRADE level for quality of evidence was moderate to very low, due to imprecision and study design limitations.High-quality, adequately-powered RCTs would be the best approach to determine the optimal method for induction of labour in women with a prior caesarean birth. However, such trials are unlikely to be undertaken due to the very large numbers needed to investigate the risk of infrequent but serious adverse outcomes (e.g. uterine rupture). Observational studies (cohort studies), including different methods of cervical ripening, may be the best alternative. Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review.
Topics: Dinoprostone; Early Termination of Clinical Trials; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic; Uterine Rupture; Vaginal Birth after Cesarean
PubMed: 28599068
DOI: 10.1002/14651858.CD009792.pub3 -
The Cochrane Database of Systematic... Dec 2016Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of labour induction using a standardised protocol.
OBJECTIVES
To determine the effects of NO donors (isosorbide mononitrate (ISMN), isosorbide dinitrate (ISDN), nitroglycerin and sodium nitroprusside) for third trimester cervical ripening or induction of labour, in comparison with placebo or no treatment or other treatments from a predefined hierarchy.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (15 August 2016) and the reference lists of trial reports.
SELECTION CRITERIA
Clinical trials comparing NO donors for cervical ripening or labour induction with other methods listed above it on a predefined list of methods of labour induction. Interventions include NO donors (isosorbide mononitrate, isosorbide dinitrate, nitroglycerin and sodium nitroprusside) compared with other methods listed above it on a predefined list of methods of labour induction.
DATA COLLECTION AND ANALYSIS
This review is part of a series of reviews focusing on methods of induction of labour, based on a generic protocol. Three review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. In this update, the quality of the evidence for the main comparison was assessed using the GRADE approach.
MAIN RESULTS
We included 23 trials (including a total of 4777 women). Included studies compared NO donors with placebo, vaginal prostaglandin E2 (PGE2), intracervical PGE2, vaginal misoprostol and intracervical Foley catheter. The majority of the included studies were assessed as being at low risk of bias. Nitric oxide versus placebo There was no evidence of a difference for any of the primary outcomes analysed: vaginal delivery not achieved in 24 hours (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.83 to 1.15; one trial, 238 women; low-quality evidence), uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.09, 95% CI 0.01 to 1.62; two trials, 300 women; low-quality evidence), caesarean section (RR 0.99, 95% CI 0.88 to 1.11; nine trials, 2624 women; moderate-quality evidence) or serious neonatal morbidity/perinatal death (average RR 1.61, 95% CI 0.08 to 33.26; two trials, 1712 women; low-quality evidence). There were no instances of serious maternal morbidity or death (one study reported this outcome).There was a reduction in an unfavourable cervix at 12 to 24 hours in women treated with NO donors (average RR 0.78, 95% CI 0.67 to 0.90; four trials, 762 women), and this difference was observed in both subgroups of standard release and slow release formulation. Women who received NO donors were less likely to experience uterine hyperstimulation without FHR rate changes (RR 0.05, 95% CI 0.00 to 0.80; one trial, 200 women), and more likely to experience side effects, including nausea, headache and vomiting. Nitric oxide donors versus vaginal prostaglandins There was no evidence of any difference between groups for uterine hyperstimulation with FHR changes or caesarean section (RR 0.97, 95% CI 0.78 to 1.21; three trials, 571 women). Serious neonatal morbidity and serious maternal morbidity were not reported. There were fewer women in the NO donor group who did not achieve a vaginal delivery within 24 hours (RR 0.63, 95% CI 0.47 to 0.86; one trial, 400 primiparae women). Nitric oxide donors versus intracervical prostaglandins One study reported a reduction in the number of women who had not achieved a vaginal delivery within 24 hours with NO donors (RR 0.63, 95% CI 0.47 to 0.86; one trial, 400 women). This result should be interpreted with caution as the information was extracted from an abstract only and a full report of the study is awaited. No differences were observed between groups for uterine hyperstimulation with FHR changes (RR 0.33, 95% CI 0.01 to 7.74; one trial, 42 women) or serious neonatal morbidity/perinatal death (RR 0.33, 95% CI 0.01 to 7.74; one trial, 42 women). Fewer women in the NO donor group underwent a caesarean section in comparison to women who received intracervical prostaglandins (RR 0.63, 95% CI 0.44 to 0.90; two trials, 442 women). No study reported on the outcome serious maternal morbidity or death. Nitric oxide donors versus vaginal misoprostol There was a reduction in the rate of uterine hyperstimulation with FHR changes with NO donors (RR 0.07, 95% CI 0.01 to 0.37; three trials, 281 women). There were no differences in caesarean section rates (RR 1.00, 95% CI 0.82 to 1.21; 761 women; six trials) and no cases of serious neonatal morbidity/perinatal death were reported. One study found that women in the NO donor group were more likely to not deliver within 24 hours (RR 5.33, 95% CI 1.62 to 17.55; one trial, 150 women). Serious maternal morbidity or death was not reported.In terms of secondary outcomes, there was an increase in cervix unchanged/unfavourable with NO (RR 3.43, 95% CI 2.07 to 5.66; two trials, 151 women) and an increase in the need for oxytocin augmentation with NO induction (RR 2.67, 95% CI 1.31 to 5.45; 7 trials; 767 women), although there was evidence of significant heterogeneity which could not be fully explained. Uterine hyperstimulation without FHR was lower in the NO group, as was meconium-stained liquor, Apgar score less than seven at five minutes and analgesia requirements. Nitric oxide donors versus intracervical catheter There was no evidence on any difference between the effects of NO and the use of a Foley catheter for induction of labour for caesarean section (RR 1.00, 95% CI 0.39 to 2.59; one trial, 80 women). No other primary outcomes were reported. One study of 75 participants did not contribute any data to the review.For all comparisons, women who received NO donors were more likely to experience side effects such as headache, nausea or vomiting.
AUTHORS' CONCLUSIONS
Available data suggests that NO donors can be a useful tool in the process of induction of labour causing the cervix to be more favourable in comparison to placebo. However, additional data are needed to assess the true impact of NO donors on all important labour process and delivery outcomes.
Topics: Administration, Intravaginal; Cervical Ripening; Dinoprostone; Female; Humans; Labor, Induced; Misoprostol; Nitric Oxide Donors; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic; Urinary Catheterization
PubMed: 27918616
DOI: 10.1002/14651858.CD006901.pub3 -
European Journal of Obstetrics,... Nov 2017Induction of labour is one of the most frequently applied obstetrical interventions globally. Many studies have compared the use of balloon catheters with... (Review)
Review
Induction of labour is one of the most frequently applied obstetrical interventions globally. Many studies have compared the use of balloon catheters with pharmacological agents. Although the safety of the balloon catheter is often mentioned, little has been written about the total spectrum of maternal and fetal morbidity associated with induction of labour using a balloon catheter. We evaluated the safety of labour induction with a transcervical balloon catheter by conducting a literature review with pooled risk assessments of the maternal, fetal and neonatal morbidity. We searched Medline, EMBASE and CINAHL as well as the Cochrane database using the Keywords 'induction of labour', 'cervical ripening', 'transcervical balloon', 'balloon catheter' and 'Foley balloon'. We did not use language or date restrictions. Randomized and quasi-randomized controlled trials as well as observational studies that contained original data on occurrence of maternal, fetal or neonatal morbidity during induction of labour with the balloon catheter were included. Studies were excluded if the balloon catheter was used concurrently with oxytocin and concurrently or consecutively with misoprostol, dinoprostone or extra-amniotic saline infusion. Study selection and quality assessment was performed by two authors independently using a standardized critical appraisal instrument. Outcomes were reported as weighted mean rates. We detected 84 articles reporting on 13,791 women. The overall risk of developing intrapartum maternal infection was 11.3% (912 of 8079 women), 3.3% (151 of 4538 women) for postpartum maternal infection and 4.6% (203 of 4460 women) for neonatal infection. Uterine hypercontractility occurred in 2.7% (148 of 5439) of the women. Uterine rupture after previous caesarean section occurred in 1.9% of women (26 of 1373), while other major maternal complications had an occurrence rate of <1%. The risk for developing minor maternal complications was <2%. The risk of developing a non-reassuring fetal heart rate was 10.8% (793 of 7336 women), 10.1% (507 of 5008 women) for fetal distress and 14.0% (460 of 3295 women) for meconium stained liquor. Neonatal death occurred in 0.29% (6 of 2058) of the deliveries and NICU admission in 7.2% (650 of 9065 deliveries). This review shows that labour induction with a balloon catheter is a safe intervention, with intrapartum maternal infection being the only reasonable risk above 10%.
Topics: Case-Control Studies; Cervical Ripening; Female; Humans; Labor, Induced; Observational Studies as Topic; Obstetric Labor Complications; Postpartum Period; Pregnancy; Pregnancy Outcome; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Urinary Catheters
PubMed: 28963922
DOI: 10.1016/j.ejogrb.2017.09.014 -
PloS One 2021As uterine rupture may affect as many as 11/1000 women with 1 prior cesarean birth and 5/10.000 women with unscarred uterus undergoing labor induction, we intended to... (Meta-Analysis)
Meta-Analysis
Prevalence of uterine rupture among women with one prior low transverse cesarean and women with unscarred uterus undergoing labor induction with PGE2: A systematic review and meta-analysis.
BACKGROUND
As uterine rupture may affect as many as 11/1000 women with 1 prior cesarean birth and 5/10.000 women with unscarred uterus undergoing labor induction, we intended to estimate the prevalence of such rare outcome when PGE2 is used for cervical ripening and labor induction.
METHODS
We searched MEDLINE, ClinicalTrials.gov and the Cochrane library up to September 1st 2020. Retrospective and prospective cohort studies, as well as randomized controlled trials (RCTs) on singleton viable pregnancies receiving PGE2 for cervical ripening and labor induction were reviewed. Prevalence of uterine rupture was meta-analyzed with Freeman-Tukey double arcsine transformation among women with 1 prior low transverse cesarean section and women with unscarred uterus.
RESULTS
We reviewed 956 full text articles to include 69 studies. The pooled prevalence rate of uterine rupture is estimated to range between 2 and 9 out of 1000 women with 1 prior low transverse cesarean (5/1000; 95%CI 2-9/1000, 122/9000). The prevalence of uterine rupture among women with unscarred uterus is extremely low, reaching at most 0.7/100.000 (<1/100.000.000; 95%CI <1/100.000.000-0.7/100.000, 8/17.684).
CONCLUSIONS
Uterine rupture is a rare event during cervical ripening and labor induction with PGE2.
Topics: Adult; Cesarean Section; Dinoprostone; Female; Humans; Labor, Induced; Pregnancy; Prevalence; Publication Bias; Uterine Rupture; Uterus
PubMed: 34228760
DOI: 10.1371/journal.pone.0253957 -
American Journal of Obstetrics and... Sep 2020Retained placenta affects 2% to 3.3% of all vaginal deliveries and is one of the leading causes of postpartum hemorrhage worldwide. Despite the prevalence of this... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Retained placenta affects 2% to 3.3% of all vaginal deliveries and is one of the leading causes of postpartum hemorrhage worldwide. Despite the prevalence of this condition, there is limited guidance on its management.
OBJECTIVE
A systematic review and meta-analysis were performed to evaluate the efficacy of pharmacologic interventions for the management of retained placenta.
STUDY DESIGN
PubMed, ClinicalTrials.gov, Cochrane Library, Web of Science, and Scopus were searched for full-text publications in English. Search terms included "retained placenta" AND "treatment" OR "therapy" OR "disease management" OR "Pitocin" OR "misoprostol" OR "Cytotec" OR "dinoprostone" OR "nitroglycerin" OR "carbetocin" OR "ergotamine," with no restriction on publication dates. Only randomized controlled trials were included. The primary outcome was the need for manual extraction of the placenta or dilation and curettage. Reviewers evaluated the quality of included articles using the Cochrane Collaboration's tool for assessing the risk of bias. Pooled risk ratios were estimated based on random- and fixed-effects analyses. Interstudy heterogeneity was considered when I≥50%.
RESULTS
The literature search identified 29 randomized controlled trials that met the inclusion criteria (2682 subjects). The most commonly used agent across the studies was oxytocin administered via umbilical vein injection; there was high heterogeneity among these studies (I=62%). Oxytocin was inferior to carbetocin (risk ratio, 1.61; 95% confidence interval, 1.03-2.52) and prostaglandins (risk ratio, 2.63; 95% confidence interval, 1.18-5.86) for the primary outcome. For oxytocin, prostaglandin agents, and nitroglycerin, there was a trend toward favoring the study drug for the primary outcome compared with control or placebo. Compared with placebo or control, estimated blood loss was lower if pharmacologic interventions were administered, with a mean difference of 121.5 mL (95% confidence interval, -185.7 to -52.3). There was no difference in postpartum hemorrhage or the need for blood transfusion between pharmacologic interventions and placebo or control.
CONCLUSION
Pooled estimates for oxytocin via umbilical vein injection, prostaglandin agents, and nitroglycerin performed favorably compared with placebo or control for the management of retained placenta. Carbetocin and prostaglandin agents were superior to oxytocin in reducing the need for manual extraction or dilation and curettage.
Topics: Female; Humans; Oxytocics; Perinatal Care; Placenta, Retained; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 32592695
DOI: 10.1016/j.ajog.2020.06.044