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The Cochrane Database of Systematic... Apr 2015Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix. Almost 50% of hysteroscopic complications are related to difficulty with cervical entry. Potential complications include cervical tears, creation of a false passage, perforation, bleeding, or simply difficulty in entering the internal os (between the cervix and the uterus) with the hysteroscope. These complications may possibly be reduced with adequate preparation of the cervix (cervical ripening) prior to hysteroscopy. Cervical ripening agents include oral or vaginal prostaglandin, which can be synthetic (e.g misoprostol) or natural (e.g. dinoprostone) and vaginal osmotic dilators, which can be naturally occurring (e.g. laminaria) or synthetic.
OBJECTIVES
To determine whether preoperative cervical preparation facilitates cervical dilatation and reduces the complications of operative hysteroscopy in women undergoing the procedure for any condition.
SEARCH METHODS
In August 2014 we searched sources including the Menstrual Disorders and Subfertility Group (MDSG) Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and reference lists of relevant articles. We searched for published and unpublished studies in any language.
SELECTION CRITERIA
Two review authors independently selected randomised controlled trials (RCTs) of cervical ripening agents used before operative hysteroscopy in pre- and postmenopausal women. Cervical ripening agents could be compared to each other, placebo or no treatment.
DATA COLLECTION AND ANALYSIS
Data extraction and quality assessment were conducted independently by two review authors. The primary review outcomes were effectiveness of cervical dilatation (defined as the proportion of women requiring mechanical cervical dilatation) and intraoperative complications. Secondary outcomes were mean time required to dilate the cervix, preoperative pain, cervical width, abandonment of the procedure, side effects of dilating agents and duration of surgery. We calculated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, with 95% confidence intervals ( CIs). Data were statistically pooled where appropriate. Heterogeneity was assessed using the I(2) statistic. The overall quality of the evidence was assessed using GRADE methods.
MAIN RESULTS
Nineteen RCTs with a total of 1870 participants were included. They compared misoprostol with no treatment or placebo, dinoprostone or osmotic dilators.Misoprostol was more effective for cervical dilatation than placebo or no intervention, with fewer women requiring mechanical dilatation (OR 0.08, 95% CI 0.04 to 0.16, five RCTs, 441 participants, I(2)=0%, moderate quality evidence). This suggests that in a population in which 80% of women undergoing hysteroscopy require mechanical dilatation without use of preoperative ripening agents, use of misoprostol will reduce the need for mechanical dilatation to between 14% and 39%. Misoprostol was associated with fewer intraoperative complications (OR 0.37, 95% CI 0.18 to 0.77, 12 RCTs, 901 participants, I(2)=0%, moderate quality evidence). This suggests that in a population in which 3% of women undergoing hysteroscopy experience intraoperative complications without use of preoperative ripening agents, use of misoprostol will reduce the risk of complications to 2% or less.When specific complications were considered, the misoprostol group had a lower rate of cervical laceration or tearing (OR 0.25, 95% CI 0.11 to 0.57, nine RCTS, 669 women, I(2)=0%, moderate quality evidence) or false track formation (OR 0.34, 95% CI 0.12 to 0.97, seven RCTs, 560 participants, I(2)=0%, moderate quality evidence). There was no evidence of a difference between the groups in rates of uterine perforation (0.42, 95% CI 0.13 to 1.38, seven RCTs, 455 participants, I(2)=0%, low quality evidence) or uterine bleeding (OR 0.51, 95% CI 0.10 to 2.49, four RCTs, 340 participants, I(2)=0%, low quality evidence). Some treatment side effects (mild abdominal pain, vaginal bleeding, and increased body temperature) were more common in the misoprostol group.Compared with dinoprostone, misoprostol was associated with more effective cervical dilatation, with fewer women requiring mechanical dilatation (OR 0.58; 95% CI 0.34 to 0.98; one RCT, 310 participants, low quality evidence) and with fewer intraoperative complications (OR 0.32; 95% CI 0.12 to 0.83, one RCT, 310 participants, low quality evidence). However treatment side effects were more common in the misoprostol arm.Compared to osmotic dilatation (laminaria), misoprostol was associated with less effective cervical dilatation, with more women in the misoprostol group requiring mechanical dilatation (OR 5.96, 95% CI 2.61 to 13.59, one RCT, 110 participants, low quality evidence). There was no evidence of a difference between misoprostol and osmotic dilators in intraoperative complication rates (OR 5.14, 95% CI 0.24 to 109.01, three RCTs, 354 participants, low quality evidence), with only two events reported altogether.The overall quality of the evidence ranged from low to moderate. The main limitations in the evidence were imprecision and poor reporting of study methods.
AUTHORS' CONCLUSIONS
There is moderate quality evidence that use of misoprostol for preoperative ripening of the cervix before operative hysteroscopy is more effective than placebo or no treatment and is associated with fewer intraoperative complications such as lacerations and false tracks. However misoprostol is associated with more side effects, including preoperative pain and vaginal bleeding. There is low quality evidence to suggest that misoprostol has fewer intraoperative complications and is more effective than dinoprostone.There is also low quality evidence to suggest that laminaria may be more effective than misoprostol, with uncertain effects for complication rates. However the possible benefits of laminaria need to be weighed against the inconvenience of its insertion and retention for one to two days.
Topics: Cervical Ripening; Cervix Uteri; Dilatation; Dinoprostone; Female; Humans; Hysteroscopy; Laminaria; Misoprostol; Oxytocics; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic
PubMed: 25906113
DOI: 10.1002/14651858.CD005998.pub2 -
PloS One 2016Marine-derived n-3 polyunsaturated fatty acids (PUFA) may have a beneficial effect on inflammation via lowering pro-inflammatory eicosanoid concentrations. We aimed to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Marine-derived n-3 polyunsaturated fatty acids (PUFA) may have a beneficial effect on inflammation via lowering pro-inflammatory eicosanoid concentrations. We aimed to assess the effect of marine-derived n-3 PUFA on prostaglandin E2 (PGE2), thromboxane B2 (TXB2), and leukotriene B4 (LTB4) through systematic review and meta-analysis of randomized controlled trials.
METHOD AND FINDINGS
A structured search strategy on PubMed, Web of Science and Cochrane up to November 2015 was undertaken in this meta-analysis. Standard mean difference was used to calculate the effect size of marine-derived n-3 PUFA on PGE2, TXB2 and LTB4 in a random-effect model. A total of 18 RCTs with 826 subjects were included in this systematic review and meta-analysis. Supplementation of marine-derived n-3 PUFA significantly decreased concentrations of TXB2 in serum/plasma in subjects with high risk of cardiovascular diseases (SMD:-1.26; 95% CI: -1.65, -0.86) and LTB4 in neutrophils in unhealthy subjects (subjects with non-autoimmune chronic diseases or auto-immune diseases) (SMD:-0.59: 95% CI: -1.02, -0.16). Subgroup analyses showed a significant reduction of LTB4 in subjects with rheumatoid arthritis (SMD: -0.83; 95% CI: -1.37, -0.29), but not in non-autoimmune chronic disease patients (SMD: -0.33; 95% CI: -0.97, 0.31). No significant publication bias was shown in the meta-analysis.
CONCLUSIONS
Marine-derived n-3 PUFA had a beneficial effect on reducing the concentration of TXB2 in blood of subjects with high risk of CVD as well as LTB4 in neutrophils in unhealthy subjects, and that subjects with RA showed lower LTB4 content with supplementation of marine-derived n-3 PUFA.
Topics: Anti-Inflammatory Agents; Arthritis, Rheumatoid; Chronic Disease; Dietary Supplements; Dinoprostone; Dose-Response Relationship, Drug; Eicosanoids; Fatty Acids, Omega-3; Fish Oils; Humans; Leukotriene B4; Randomized Controlled Trials as Topic; Research Design; Thromboxane B2; Treatment Outcome
PubMed: 26808318
DOI: 10.1371/journal.pone.0147351 -
The Cochrane Database of Systematic... Oct 2009Oxytocin is the commonest induction agent used worldwide. It has been used alone, in combination with amniotomy or following cervical ripening with other pharmacological... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Oxytocin is the commonest induction agent used worldwide. It has been used alone, in combination with amniotomy or following cervical ripening with other pharmacological or non-pharmacological methods.
OBJECTIVES
To determine the effects of oxytocin alone for third trimester cervical ripening and induction of labour in comparison with other methods of induction of labour or placebo/no treatment.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2009) and bibliographies of relevant papers.
SELECTION CRITERIA
Randomised and quasi-randomised trials comparing intravenous oxytocin with placebo or no treatment, or with prostaglandins (vaginal or intracervical) for third trimester cervical ripening or labour induction.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed eligibility and carried out data extraction.
MAIN RESULTS
Sixty-one trials (12,819 women) are included.When oxytocin inductions were compared with expectant management, fewer women failed to deliver vaginally within 24 hours (8.4% versus 53.8%, risk ratio (RR) 0.16, 95% confidence interval (CI) 0.10 to 0.25). There was a significant increase in the number of women requiring epidural analgesia (RR 1.10, 95% CI 1.04 to 1.17). Fewer women were dissatisfied with oxytocin induction in the one trial reporting this outcome (5.9% versus 13.7%, RR 0.43, 95% CI 0.33 to 0.56).Compared with vaginal prostaglandins, oxytocin increased unsuccessful vaginal delivery within 24 hours in the two trials reporting this outcome (70% versus 21%, RR 3.33, 95% CI 1.61 to 6.89). There was a small increase in epidurals when oxytocin alone was used (RR 1.09, 95% CI 1.01 to 1.17).Most of the studies included women with ruptured membranes, and there was some evidence that vaginal prostaglandin increased infection in mothers (chorioamnionitis RR 0.66, 95% CI 0.47 to 0.92) and babies (use of antibiotics RR 0.68, 95% CI 0.53 to 0.87). These data should be interpreted cautiously as infection was not pre-specified in the original review protocol.When oxytocin was compared with intracervical prostaglandins, there was an increase in unsuccessful vaginal delivery within 24 hours (50.4% versus 34.6%, RR 1.47, 95% CI 1.10 to 1.96) and an increase in caesarean sections (19.1% versus 13.7%, RR 1.37, 95% CI 1.08 to 1.74) in the oxytocin group.
AUTHORS' CONCLUSIONS
Comparison of oxytocin with either intravaginal or intracervical PGE2 reveals that the prostaglandin agents probably increase the chances of achieving vaginal birth within 24 hours. Oxytocin induction may increase the rate of interventions in labour.A suggestion that for women with prelabour rupture of membranes induction with vaginal prostaglandin may increase risk of infection for mother and baby warrants further study.
Topics: Cervical Ripening; Dinoprostone; Female; Humans; Injections, Intravenous; Labor, Induced; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 19821304
DOI: 10.1002/14651858.CD003246.pub2 -
The Cochrane Database of Systematic... Apr 2009More than 20% of women undergo induction of labour in some countries. The different methods used to induce labour have been the focus of previous reviews, but the... (Comparative Study)
Comparative Study Review
BACKGROUND
More than 20% of women undergo induction of labour in some countries. The different methods used to induce labour have been the focus of previous reviews, but the setting in which induction takes place (hospital versus outpatient settings) may have implications for maternal satisfaction and costs. It is not known whether some methods of induction that are effective and safe in hospital are suitable in outpatient settings.
OBJECTIVES
To assess the effects on outcomes for mothers and babies of induction of labour for women managed as outpatients versus inpatients.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December 2008).
SELECTION CRITERIA
Published and unpublished randomised and quasi-randomised trials in which inpatient and outpatient methods of cervical ripening or induction of labour have been compared.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial reports for inclusion. Two review authors carried out data extraction and assessment of risk of bias independently.
MAIN RESULTS
We included three trials, with a combined total of 612 women in the review; each examined a different method of induction and we were unable to pool the results from trials.1. Vaginal PGE2 (One study including 201 women). There were no differences between women managed as out- versus inpatients for most review outcomes. Women in the outpatient group were more likely to have instrumental deliveries (risk ratio (RR) 1.74; 95% confidence interval (CI) 1.03 to 2.93). The overall length of hospital stay was similar in the two groups.2. Controlled release PGE2 10mg (one study including 300 women). There was no evidence of differences between groups for most review outcomes, including success of induction. During the induction period itself, women in the outpatient group were more likely to report high levels of satisfaction with their care (satisfaction rated seven or more on a nine-point scale RR 1.42; 95% CI 1.11 to 1.81), but satisfaction scores measured postnatally were similar in the two groups.3. Foley catheter (one study including 111 women). There was no evidence of differences between groups for caesarean section rates, total induction time and the numbers of babies admitted to neonatal intensive care.
AUTHORS' CONCLUSIONS
The data available to evaluate the efficacy or potential hazards of outpatient induction are limited. It is, therefore, not yet possible to determine whether induction of labour is effective and safe in outpatient settings.
Topics: Ambulatory Care; Catheterization; Cervical Ripening; Dinoprostone; Female; Hospitalization; Humans; Infant, Newborn; Labor, Induced; Length of Stay; Oxytocics; Patient Satisfaction; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic
PubMed: 19370687
DOI: 10.1002/14651858.CD007372.pub2 -
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 -
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 -
The Cochrane Database of Systematic... 2000Intravenous prostaglandin E2 and F2 alpha can be used to induce labour. The use of intravenous prostaglandins in this context has been limited by perceived unacceptable... (Review)
Review
BACKGROUND
Intravenous prostaglandin E2 and F2 alpha can be used to induce labour. The use of intravenous prostaglandins in this context has been limited by perceived unacceptable maternal side effect profiles. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
OBJECTIVES
To determine the effects of intravenous prostaglandin for third trimester cervical ripening or induction of labour.
SEARCH STRATEGY
The Cochrane Pregnancy and Childbirth Group trials register, The Cochrane Controlled Trials Register and bibliographies of relevant papers.
SELECTION CRITERIA
The criteria for inclusion included the following: (1) clinical trials comparing intravenous prostaglandin used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions.
DATA COLLECTION AND ANALYSIS
A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. The initial data extraction is done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data will then be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. To avoid duplication of data in the primary reviews, the labour induction methods have been listed in a specific order, from one to 25. Each primary review includes comparisons between one of the methods (from two to 25) with only those methods above it on the list.
MAIN RESULTS
Thirteen trials were eligible for inclusion in this review. Two trials (comprising 400 women) compared intravenous prostaglandin E2 to intravenous oxytocin, a further seven trials (comprising 590 women) compared intravenous prostaglandin F2 alpha to intravenous oxytocin. Two trials (comprising 115 women) each randomised women to one of three treatment arms namely intravenous oxytocin or intravenous prostaglandin F2 alpha or prostaglandin E2. One trial reported a comparison of combined oxytocin and prostaglandin F2 alpha and oxytocin alone in 20 women and lastly one trial compared extra amniotic prostaglandin E2 versus intravenous prostaglandin E2 (40 women). The use of intravenous prostaglandin was associated with higher rates of uterine hyperstimulation with changes in the fetal heart rate (relative risk (RR) 6.76, 95% confidence interval (CI) 1.23-37.11) and without (RR 4.25, 95%CI 1.48-12.24) compared to oxytocin. Use of prostaglandins was also associated with significantly more maternal side effects (gastrointestinal, thrombophlebitis and pyrexia, RR 3.75, 95% CI 2.46-5.70) than oxytocin. Prostaglandin was no more likely to result in vaginal delivery than oxytocin (RR 0.85, 95% CI 0.61-1.18). No significant differences emerged from subgroup analysis or from the trials comparing combination oxytocin/prostaglandin F2 alpha and oxytocin or extra amniotic versus intravenous prostaglandin E2.
REVIEWER'S CONCLUSIONS
Intravenous prostaglandin is no more efficient than intravenous oxytocin for the induction of labour but its use is associated with higher rates of maternal side effects and uterine hyperstimulation than oxytocin. No conclusions can be drawn form the comparisons of combination of prostaglandin F2 alpha and oxytocin compared to oxytocin alone or extra amniotic and intravenous prostaglandin E2.
Topics: Clinical Trials as Topic; Dinoprost; Dinoprostone; Female; Humans; Injections, Intravenous; Labor, Induced; Oxytocics; Oxytocin; Pregnancy
PubMed: 11034778
DOI: 10.1002/14651858.CD002864 -
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 -
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 -
Disease Markers 2009Inflammation is critical in abdominal aortic aneurysm (AAA) but there is no current consensus on which inflammation related cytokines are important. The aim of this... (Review)
Review
OBJECTIVES
Inflammation is critical in abdominal aortic aneurysm (AAA) but there is no current consensus on which inflammation related cytokines are important. The aim of this review was to systemically assess previous studies investigating the relative expression of inflammation associated cytokines within human AAA samples.
METHODS
The MEDLINE database was searched for studies which simultaneously examined an array of different inflammation associated cytokines in aortic samples in order to identify those associated with AAA. Focused searches were then conducted for further studies assessing relative concentrations of these cytokines in aortic samples in relation to AAA. Appropriate studies were assessed by two reviewers independently.
RESULTS
Eighteen studies were included. A number of different cytokines have been consistently found to be upregulated within AAA by comparison to aortic samples removed from patients without cardiovascular disease, however findings relative to samples of aortic athero-thrombosis were less consistent. TNFA and INFG appear to be the most consistently associated with AAA in studies using both normal and atherosclerotic controls. Cautious interpretation of these data is recommended due to a number of methodological problems.
CONCLUSIONS
This systematic review suggests that TNFA and INFG are the most consistently upregulated cytokines in large AAAs. Further studies utilizing larger populations, new proteomic techniques and better patient matching are required.
Topics: Aortic Aneurysm, Abdominal; Biomarkers; Chemokine CCL2; Cytokines; Dinoprostone; Humans; Inflammation; Interferon-gamma; Tumor Necrosis Factor-alpha; Up-Regulation
PubMed: 19729799
DOI: 10.3233/DMA-2009-0629