Induction of Labour
TL;DR: The most current literature is reviewed to provide evidence-based recommendations to obstetrical care providers on induction of labour and appropriate timing and method of induction, appropriate mode of delivery, and optimal maternal and perinatal outcomes.
Abstract: Objective To review the most current literature in order to provide evidence-based recommendations to obstetrical care providers on induction of labour. Options Intervention in a pregnancy with induction of labour. Outcomes Appropriate timing and method of induction, appropriate mode of delivery, and optimal maternal and perinatal outcomes. Evidence Published literature was retrieved through searches of PubMed, CINAHL, and The Cochrane Library in 2010 using appropriate controlled vocabulary (e.g., labour, induced, labour induction, cervical ripening) and key words (e.g., induce, induction, augmentation). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to the end of 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Values The evidence in this document was rated using criteria described in the Report of the Canadian Task Force on Preventative Health Care (Table 1).
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TL;DR: Evaluated the effectiveness and safety of continuous cardiotocography when used as a method to monitor fetal wellbeing during labour, which showed no significant improvement in overall perinatal death rate.
Abstract: Background
Cardiotocography (CTG) records changes in the fetal heart rate and their temporal relationship to uterine contractions. The aim is to identify babies who may be short of oxygen (hypoxic) to guide additional assessments of fetal wellbeing, or determine if the baby needs to be delivered by caesarean section or instrumental vaginal birth. This is an update of a review previously published in 2013, 2006 and 2001.
Objectives
To evaluate the effectiveness and safety of continuous cardiotocography when used as a method to monitor fetal wellbeing during labour.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 November 2016) and reference lists of retrieved studies.
Selection criteria
Randomised and quasi-randomised controlled trials involving a comparison of continuous cardiotocography (with and without fetal blood sampling) with no fetal monitoring, intermittent auscultation intermittent cardiotocography.
Data collection and analysis
Two review authors independently assessed study eligibility, quality and extracted data from included studies. Data were checked for accuracy.
Main results
We included 13 trials involving over 37,000 women. No new studies were included in this update.
One trial (4044 women) compared continuous CTG with intermittent CTG, all other trials compared continuous CTG with intermittent auscultation. No data were found comparing no fetal monitoring with continuous CTG. Overall, methodological quality was mixed. All included studies were at high risk of performance bias, unclear or high risk of detection bias, and unclear risk of reporting bias. Only two trials were assessed at high methodological quality.
Compared with intermittent auscultation, continuous cardiotocography showed no significant improvement in overall perinatal death rate (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.59 to 1.23, N = 33,513, 11 trials, low quality evidence), but was associated with halving neonatal seizure rates (RR 0.50, 95% CI 0.31 to 0.80, N = 32,386, 9 trials, moderate quality evidence). There was no difference in cerebral palsy rates (RR 1.75, 95% CI 0.84 to 3.63, N = 13,252, 2 trials, low quality evidence). There was an increase in caesarean sections associated with continuous CTG (RR 1.63, 95% CI 1.29 to 2.07, N = 18,861, 11 trials, low quality evidence). Women were also more likely to have instrumental vaginal births (RR 1.15, 95% CI 1.01 to 1.33, N = 18,615, 10 trials, low quality evidence). There was no difference in the incidence of cord blood acidosis (RR 0.92, 95% CI 0.27 to 3.11, N = 2494, 2 trials, very low quality evidence) or use of any pharmacological analgesia (RR 0.98, 95% CI 0.88 to 1.09, N = 1677, 3 trials, low quality evidence).
Compared with intermittent CTG, continuous CTG made no difference to caesarean section rates (RR 1.29, 95% CI 0.84 to 1.97, N = 4044, 1 trial) or instrumental births (RR 1.16, 95% CI 0.92 to 1.46, N = 4044, 1 trial). Less cord blood acidosis was observed in women who had intermittent CTG, however, this result could have been due to chance (RR 1.43, 95% CI 0.95 to 2.14, N = 4044, 1 trial).
Data for low risk, high risk, preterm pregnancy and high-quality trials subgroups were consistent with overall results. Access to fetal blood sampling did not appear to influence differences in neonatal seizures or other outcomes.
Evidence was assessed using GRADE. Most outcomes were graded as low quality evidence (rates of perinatal death, cerebral palsy, caesarean section, instrumental vaginal births, and any pharmacological analgesia), and downgraded for limitations in design, inconsistency and imprecision of results. The remaining outcomes were downgraded to moderate quality (neonatal seizures) and very low quality (cord blood acidosis) due to similar concerns over limitations in design, inconsistency and imprecision.
Authors' conclusions
CTG during labour is associated with reduced rates of neonatal seizures, but no clear differences in cerebral palsy, infant mortality or other standard measures of neonatal wellbeing. However, continuous CTG was associated with an increase in caesarean sections and instrumental vaginal births. The challenge is how best to convey these results to women to enable them to make an informed decision without compromising the normality of labour.
The question remains as to whether future randomised trials should measure efficacy (the intrinsic value of continuous CTG in trying to prevent adverse neonatal outcomes under optimal clinical conditions) or effectiveness (the effect of this technique in routine clinical practice).
Along with the need for further investigations into long-term effects of operative births for women and babies, much remains to be learned about the causation and possible links between antenatal or intrapartum events, neonatal seizures and long-term neurodevelopmental outcomes, whilst considering changes in clinical practice over the intervening years (one-to-one-support during labour, caesarean section rates). The large number of babies randomised to the trials in this review have now reached adulthood and could potentially provide a unique opportunity to clarify if a reduction in neonatal seizures is something inconsequential that should not greatly influence women's and clinicians' choices, or if seizure reduction leads to long-term benefits for babies. Defining meaningful neurological and behavioural outcomes that could be measured in large cohorts of young adults poses huge challenges. However, it is important to collect data from these women and babies while medical records still exist, where possible describe women's mobility and positions during labour and birth, and clarify if these might impact on outcomes. Research should also address the possible contribution of the supine position to adverse outcomes for babies, and assess whether the use of mobility and positions can further reduce the low incidence of neonatal seizures and improve psychological outcomes for women.
818 citations
TL;DR: Evidence suggests that epidural, combined spinal epidural (CSE) and inhaled analgesia effectively manage pain in labour, but may give rise to adverse effects.
Abstract: Background:
The pain that women experience during labour is affected by multiple physiological and psychosocial factors and its intensity can vary greatly. Most women in labour require pain relief. Pain management strategies include non-pharmacological interventions (that aim to help women cope with pain in labour) and pharmacological interventions (that aim to relieve the pain of labour).
Objectives:
To summarise the evidence from Cochrane systematic reviews on the efficacy and safety of non-pharmacological and pharmacological interventions to manage pain in labour. We considered findings from non-Cochrane systematic reviews if there was no relevant Cochrane review.
Methods:
We searched the Cochrane Database of Systematic Reviews (The Cochrane Library 2011, Issue 5), The Cochrane Database of Abstracts of Reviews of Effects (The Cochrane Library 2011, Issue 2 of 4), MEDLINE (1966 to 31 May 2011) and EMBASE (1974 to 31 May 2011) to identify all relevant systematic reviews of randomised controlled trials of pain management in labour. Each of the contributing Cochrane reviews (nine new, six updated) followed a generic protocol with 13 common primary efficacy and safety outcomes. Each Cochrane review included comparisons with placebo, standard care or with a different intervention according to a predefined hierarchy of interventions. Two review authors extracted data and assessed methodological quality, and data were checked by a third author. This overview is a narrative summary of the results obtained from individual reviews.
Main results:
We identified 15 Cochrane reviews (255 included trials) and three non-Cochrane reviews (55 included trials) for inclusion within this overview. For all interventions, with available data, results are presented as comparisons of: 1. Intervention versus placebo or standard care; 2. Different forms of the same intervention (e.g. one opioid versus another opioid); 3. One type of intervention versus a different type of intervention (e.g. TENS versus opioid). Not all reviews included results for all comparisons. Most reviews compared the intervention with placebo or standard care, but with the exception of opioids and epidural analgesia, there were few direct comparisons between different forms of the same intervention, and even fewer comparisons between different interventions. Based on these three comparisons, we have categorised interventions into: " What works" ,"What may work", and "Insufficient evidence to make a judgement".WHAT WORKSEvidence suggests that epidural, combined spinal epidural (CSE) and inhaled analgesia effectively manage pain in labour, but may give rise to adverse effects. Epidural, and inhaled analgesia effectively relieve pain when compared with placebo or a different type of intervention (epidural versus opioids). Combined-spinal epidurals relieve pain more quickly than traditional or low dose epidurals. Women receiving inhaled analgesia were more likely to experience vomiting, nausea and dizziness.When compared with placebo or opioids, women receiving epidural analgesia had more instrumental vaginal births and caesarean sections for fetal distress, although there was no difference in the rates of caesarean section overall. Women receiving epidural analgesia were more likely to experience hypotension, motor blockade, fever or urinary retention. Less urinary retention was observed in women receiving CSE than in women receiving traditional epidurals. More women receiving CSE than low-dose epidural experienced pruritus. WHAT MAY WORKThere is some evidence to suggest that immersion in water, relaxation, acupuncture, massage and local anaesthetic nerve blocks or non-opioid drugs may improve management of labour pain, with few adverse effects. Evidence was mainly limited to single trials. These interventions relieved pain and improved satisfaction with pain relief (immersion, relaxation, acupuncture, local anaesthetic nerve blocks, non-opioids) and childbirth experience (immersion, relaxation, non-opioids) when compared with placebo or standard care. Relaxation was associated with fewer assisted vaginal births and acupuncture was associated with fewer assisted vaginal births and caesarean sections.INSUFFICIENT EVIDENCEThere is insufficient evidence to make judgements on whether or not hypnosis, biofeedback, sterile water injection, aromatherapy, TENS, or parenteral opioids are more effective than placebo or other interventions for pain management in labour. In comparison with other opioids more women receiving pethidine experienced adverse effects including drowsiness and nausea.
Authors' conclusions:
Most methods of non-pharmacological pain management are non-invasive and appear to be safe for mother and baby, however, their efficacy is unclear, due to limited high quality evidence. In many reviews, only one or two trials provided outcome data for analysis and the overall methodological quality of the trials was low. High quality trials are needed.There is more evidence to support the efficacy of pharmacological methods, but these have more adverse effects. Thus, epidural analgesia provides effective pain relief but at the cost of increased instrumental vaginal birth.It remains important to tailor methods used to each woman's wishes, needs and circumstances, such as anticipated duration of labour, the infant's condition, and any augmentation or induction of labour.A major challenge in compiling this overview, and the individual systematic reviews on which it is based, has been the variation in use of different process and outcome measures in different trials, particularly assessment of pain and its relief, and effects on the neonate after birth. This made it difficult to pool results from otherwise similar studies, and to derive conclusions from the totality of evidence. Other important outcomes have simply not been assessed in trials; thus, despite concerns for 30 years or more about the effects of maternal opioid administration during labour on subsequent neonatal behaviour and its influence on breastfeeding, only two out of 57 trials of opioids reported breastfeeding as an outcome. We therefore strongly recommend that the outcome measures, agreed through wide consultation for this project, are used in all future trials of methods of pain management.
539 citations
TL;DR: Mechanical methods reduced the risk of hyperstimulation with fetal heart rate changes when compared with vaginal prostaglandins: vaginal PGE2 (eight studies; 1203 women, RR 0.16; 95% confidence interval (CI) 0.64 to 1.26) and misoprostol (3% versus 9%).
Abstract: Background
Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods, may include simplicity of preservation, lower cost and reduction of the side effects.
Objectives
To determine the effects of mechanical methods for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment, prostaglandins (vaginal and intracervical prostaglandin E2 (PGE2), misoprostol) and oxytocin.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2011) and bibliographies of relevant papers. We updated this search on 16 January 2012 and added the results to the awaiting classification section of the review.
Selection criteria
Clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with methods listed above it on a predefined list of methods of labour. A comparison with amniotomy will be added, should this comparison be made in future trials.
Different types of intervention have been considered as mechanical methods: (1) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (2) the introduction of a catheter through the cervix into the extra-amniotic space, with or without traction; (3) use of a catheter to inject fluidsin the extra-amniotic space
In addition, we made other comparisons: (1) specific mechanical methods (balloon catheter and laminaria tents) compared with any prostaglandins or with oxytocin; (2) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins alone.
Data collection and analysis
Two review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data.
Main results
For this update we have included a further 27 studies. The review includes 71 randomised controlled trials (total of 9722 women), ranging from 39 to 588 women per study. Most studies reported on caesarean section, all other outcomes are based on substantially fewer women. Four additional studies are ongoing.
Mechanical methods versus no treatment: one study (48 woman) reported on women who did not achieve vaginal delivery within 24 hours (risk ratio (RR) 0.90; 95% confidence interval (CI) 0.64 to 1.26). The risk of caesarean section was similar between groups (six studies; 416 women, RR 1.00; 95% CI 0.76 to 1.30). There were no cases of severe neonatal and maternal morbidity.
Mechanical methods versus vaginal PGE2 (17 studies;1894 woman): The proportion of women who did not achieve vaginal delivery within 24 hours was not significantly different (three studies; 586 women RR 1.72; 95% CI 0.90 to 3.27); however, for the subgroup of multiparous women the risk of not achieving delivery within 24 hours was higher (one study; 147 women RR 4.38, 95% CI 1.74 to 10.98), with no increase in caesarean sections (RR 1.19, 95% CI 0.62-2.29). Compared with intracervical PGE2 (14 studies;1784 women and misoprostol there was no significant difference in the proportion of women not achieving vaginal delivery within 24 hours.
Mechanical methods reduced the risk of hyperstimulation with fetal heart rate changes when compared with vaginal prostaglandins: vaginal PGE2 (eight studies; 1203 women, RR 0.16; 95% CI 0.06 to 0.39) and misoprostol (3% versus 9%) (nine studies; 1615 women, RR 0.37; 95% CI 0.25 to 0.54). Risk of caesarean section between mechanical methods and prostaglandins was comparable. Serious neonatal and maternal morbidity were infrequently reported and did not differ between the groups.
Mechanical methods compared with induction with oxytocin (reduced the risk of caesarean section (five studies; 398 women, RR 0.62; 95% CI 0.42 to 0.90). The likelihood of vaginal delivery within 24 hours was not reported. Hyperstimulation with fetal heart rate changes was reported in one study (200 participants), and did not differ. There were no reported cases of severe maternal or neonatal morbidity.
Authors' conclusions
Induction of labour using mechanical methods results in similar caesarean section rates as prostaglandins, for a lower risk of hyperstimulation. Mechanical methods do not increase the overall number of women not delivered within 24 hours, however the proportion of multiparous women who did not achieve vaginal delivery within 24 hours was higher when compared with vaginal PGE2. Compared with oxytocin, mechanical methods reduce the risk of caesarean section.
470 citations
TL;DR: Prostaglandins PGE2 probably increase the chance of vaginal delivery in 24 hours, they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates, and small differences are detected between some outcomes, but these maybe due to chance.
Abstract: Background
Prostaglandins have been used for induction of labour since the 1960s. Initial work focused on prostaglandin F2a as prostaglandin E2 was considered unsuitable for a number of reasons. With the development of alternative routes of administration, comparisons were made between various formulations of vaginal prostaglandins.
Objectives
To determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except misoprostol).
Search methods
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2009) and bibliographies of relevant papers. We updated this search on 24 February 2012 and added the results to the awaiting classification section.
Selection criteria
Clinical trials comparing vaginal prostaglandins 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.
Data collection and analysis
We assessed studies and extracted data independently.
Main results
Sixty-three (10,441 women) have been included.
Vaginal prostaglandin E2 compared with placebo or no treatment reduced the likelihood of vaginal delivery not being achieved within 24 hours (18.1% versus 98.9%, risk ratio (RR) 0.19, 95% confidence interval (CI) 0.14 to 0.25, two trials, 384 women). The risk of the cervix remaining unfavourable or unchanged was reduced (21.6% versus 40.3%, RR 0.46, 95% CI 0.35 to 0.62, five trials, 467 women); and the risk of oxytocin augmentation reduced (35.1% versus 43.8%, RR 0.83, 95% CI 0.73 to 0.94, 12 trials, 1321 women) when PGE2 was compared to placebo. There was no evidence of a difference between caesarean section rates, although the risk of uterine hyperstimulation with fetal heart rate changes was increased (4.4% versus 0.49%, RR 4.14, 95% CI 1.93 to 8.90, 14 trials, 1259 women).
PGE2 tablet, gel and pessary appear to be as efficacious as each other and the use of sustained release PGE2 inserts appear to be associated with a reduction in instrumental vaginal delivery rates (9.9 % versus 19.5%, RR 0.51, 95% CI 0.35 to 0.76, NNT 10 (6.7 to 24.0), five trials, 661 women) when compared to vaginal PGE2 gel or tablet.
Authors' conclusions
PGE2 increases successful vaginal delivery rates in 24 hours and cervical favourability with no increase in operative delivery rates. Sustained release vaginal PGE2 is superior to vaginal PGE2 gel with respect to some outcomes studied.
Further research is needed to assess the best vehicle for delivering vaginal prostaglandins and this should, where possible, include some examination of the cost-analysis.
[Note: The 10 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]
291 citations
TL;DR: To examine the value of pre‐induction sonographic assessment of cervical length, posterior cervical angle and occipital position in the prediction of the induction‐to‐delivery interval within 24 h and the likelihood of Cesarean section, sonographic Assessment with the Bishop score is compared.
Abstract: Objectives
To examine the value of pre-induction sonographic assessment of cervical length, posterior cervical angle and occipital position in the prediction of the induction-to-delivery interval within 24 h, the likelihood of vaginal delivery within 24 h, the likelihood of Cesarean section and to compare sonographic assessment with the Bishop score.
Methods
In 604 singleton pregnancies, induction of labor was carried out at 35–42 weeks of gestation. Immediately before induction, transvaginal sonography was performed for measurement of cervical length and posterior cervical angle and a transabdominal scan was carried out to determine the position of the fetal occiput. The value of occipital position, posterior cervical angle, cervical length, parity, gestational age, maternal age, and body mass index (BMI) on the induction-to-delivery interval within 24 h, the likelihood of vaginal delivery within 24 h and the likelihood of Cesarean section were investigated by Cox proportional hazard model or logistic regression analysis.
Results
Vaginal delivery occurred in 484 (80.1%) women and this was within 24 h of induction in 388 (64.2%). Cesarean section was performed in 120 (19.9%). Occiput-anterior (OA) and transverse (OT) positions were analyzed as one group as the odds ratios (OR) and the HR were similar and different from occiput-posterior (OP), which was analyzed as another group. Prediction of the induction-to-delivery interval was provided by the occipital position, pre-induction cervical length, parity and posterior cervical angle. Prediction of the likelihood of vaginal delivery within 24 h was provided by the occipital position, cervical length, posterior cervical angle and BMI. Prediction of the likelihood of Cesarean section was provided by the occipital position, cervical length, parity, maternal age and BMI. In the prediction of vaginal delivery within 24 h, for a specificity of 75%, the sensitivity for ultrasound findings was 89% and for the Bishop score it was 65%. The respective sensitivities for Cesarean section were 78% and 53%.
Conclusion
In women undergoing induction of labor, significant independent prediction of the induction-to-delivery interval within 24 h, the likelihood of vaginal delivery within 24 h and the likelihood of Cesarean section are provided by pre-induction cervical length, occipital position, posterior cervical angle and maternal characteristics. Sonographic parameters were superior to the Bishop score in the prediction of the outcome of induction. Copyright © 2004 ISUOG. Published by John Wiley & Sons, Ltd.
156 citations
References
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Journal Article•
TL;DR: Although universal screening for GBS colonization is anticipated to result in further reductions in the burden of GBS disease, the need to monitor for potential adverse consequences of intrapartum antibiotic use, such as emergence of bacterial antimicrobial resistance or increased incidence or severity of non-GBS neonatal pathogens, continues.
Abstract: Despite substantial progress in prevention of perinatal group B streptococcal (GBS) disease since the 1990s, GBS remains the leading cause of early-onset neonatal sepsis in the United States In 1996, CDC, in collaboration with relevant professional societies, published guidelines for the prevention of perinatal group B streptococcal disease (CDC Prevention of perinatal group B streptococcal disease: a public health perspective MMWR 1996;45[No RR-7]); those guidelines were updated and republished in 2002 (CDC Prevention of perinatal group B streptococcal disease: revised guidelines from CDC MMWR 2002;51[No RR-11]) In June 2009, a meeting of clinical and public health representatives was held to reevaluate prevention strategies on the basis of data collected after the issuance of the 2002 guidelines This report presents CDC's updated guidelines, which have been endorsed by the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American College of Nurse-Midwives, the American Academy of Family Physicians, and the American Society for Microbiology The recommendations were made on the basis of available evidence when such evidence was sufficient and on expert opinion when available evidence was insufficient The key changes in the 2010 guidelines include the following: • expanded recommendations on laboratory methods for the identification of GBS, • clarification of the colony-count threshold required for reporting GBS detected in the urine of pregnant women, • updated algorithms for GBS screening and intrapartum chemoprophylaxis for women with preterm labor or preterm premature rupture of membranes, • a change in the recommended dose of penicillin-G for chemoprophylaxis, • updated prophylaxis regimens for women with penicillin allergy, and • a revised algorithm for management of newborns with respect to risk for early-onset GBS disease Universal screening at 35-37 weeks' gestation for maternal GBS colonization and use of intrapartum antibiotic prophylaxis has resulted in substantial reductions in the burden of early-onset GBS disease among newborns Although early-onset GBS disease has become relatively uncommon in recent years, the rates of maternal GBS colonization (and therefore the risk for early-onset GBS disease in the absence of intrapartum antibiotic prophylaxis) remain unchanged since the 1970s Continued efforts are needed to sustain and improve on the progress achieved in the prevention of GBS disease There also is a need to monitor for potential adverse consequences of intrapartum antibiotic prophylaxis (eg, emergence of bacterial antimicrobial resistance or increased incidence or severity of non-GBS neonatal pathogens) In the absence of a licensed GBS vaccine, universal screening and intrapartum antibiotic prophylaxis continue to be the cornerstones of early-onset GBS disease prevention
2,823 citations
Journal Article•
TL;DR: Elective induction of labor is considered a controversial aspect of pregnancy management because its advantages are that it combines an easy short and convenient labor with a minimal and acceptable rate of perinatal mortality.
1,142 citations
TL;DR: A discussion of terminology and nomenclature for the description of fetal heart tracings and uterine contractions for use in clinical practice and research and a three-tier system for fetal heart rate tracing interpretation are described.
542 citations
TL;DR: Vaginal misoprostol labour induction was associated with less epidural analgesia use, fewer failures to achieve vaginal delivery within 24 hours and more uterine hyperstimulation.
Abstract: Background
Misoprostol (Cytotec, Searle) is a prostaglandin E1 analogue widely used for off-label indications such as induction of abortion and of labour. 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 vaginal misoprostol for third trimester cervical ripening or induction of labour.
Search methods
The Cochrane Pregnancy and Childbirth Group's Trials Register (November 2008) and bibliographies of relevant papers. We updated this search on 15 February 2012 and added the results to the awaiting classification section.
Selection criteria
Clinical trials comparing vaginal misoprostol 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.
Data collection and analysis
We developed a strategy to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction.
We used fixed-effect Mantel-Haenszel meta-analysis for combining dichotomous data.
If we identified substantial heterogeneity (I² greater than 50%), we used a random-effects method.
Main results
We included 121 trials. The risk of bias must be kept in mind as only 13 trials were double blind.
Compared to placebo, misoprostol was associated with reduced failure to achieve vaginal delivery within 24 hours (average relative risk (RR) 0.51, 95% confidence interval (CI) 0.37 to 0.71). Uterine hyperstimulation, without fetal heart rate (FHR) changes, was increased (RR 3.52 95% CI 1.78 to 6.99).
Compared with vaginal prostaglandin E2, intracervical prostaglandin E2 and oxytocin, vaginal misoprostol was associated with less epidural analgesia use, fewer failures to achieve vaginal delivery within 24 hours and more uterine hyperstimulation. Compared with vaginal or intracervical prostaglandin E2, oxytocin augmentation was less common with misoprostol and meconium-stained liquor more common.
Lower doses of misoprostol compared to higher doses were associated with more need for oxytocin augmentation and less uterine hyperstimulation, with and without FHR changes.
We found no information on women's views.
Authors' conclusions
Vaginal misoprostol in doses above 25 mcg four-hourly was more effective than conventional methods of labour induction, but with more uterine hyperstimulation. Lower doses (25 mcg four-hourly or less) were similar to conventional methods in effectiveness and risks. The authors request information on cases of uterine rupture known to readers. The vaginal route should not be researched further as another Cochrane review has shown that the oral route of administration is preferable to the vaginal route. Professional and governmental bodies should agree guidelines for the use of misoprostol, based on the best available evidence and local circumstances.
[Note: The 27 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]
472 citations
TL;DR: Mechanical methods reduced the risk of hyperstimulation with fetal heart rate changes when compared with vaginal prostaglandins: vaginal PGE2 (eight studies; 1203 women, RR 0.16; 95% confidence interval (CI) 0.64 to 1.26) and misoprostol (3% versus 9%).
Abstract: Background
Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods, may include simplicity of preservation, lower cost and reduction of the side effects.
Objectives
To determine the effects of mechanical methods for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment, prostaglandins (vaginal and intracervical prostaglandin E2 (PGE2), misoprostol) and oxytocin.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2011) and bibliographies of relevant papers. We updated this search on 16 January 2012 and added the results to the awaiting classification section of the review.
Selection criteria
Clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with methods listed above it on a predefined list of methods of labour. A comparison with amniotomy will be added, should this comparison be made in future trials.
Different types of intervention have been considered as mechanical methods: (1) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (2) the introduction of a catheter through the cervix into the extra-amniotic space, with or without traction; (3) use of a catheter to inject fluidsin the extra-amniotic space
In addition, we made other comparisons: (1) specific mechanical methods (balloon catheter and laminaria tents) compared with any prostaglandins or with oxytocin; (2) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins alone.
Data collection and analysis
Two review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data.
Main results
For this update we have included a further 27 studies. The review includes 71 randomised controlled trials (total of 9722 women), ranging from 39 to 588 women per study. Most studies reported on caesarean section, all other outcomes are based on substantially fewer women. Four additional studies are ongoing.
Mechanical methods versus no treatment: one study (48 woman) reported on women who did not achieve vaginal delivery within 24 hours (risk ratio (RR) 0.90; 95% confidence interval (CI) 0.64 to 1.26). The risk of caesarean section was similar between groups (six studies; 416 women, RR 1.00; 95% CI 0.76 to 1.30). There were no cases of severe neonatal and maternal morbidity.
Mechanical methods versus vaginal PGE2 (17 studies;1894 woman): The proportion of women who did not achieve vaginal delivery within 24 hours was not significantly different (three studies; 586 women RR 1.72; 95% CI 0.90 to 3.27); however, for the subgroup of multiparous women the risk of not achieving delivery within 24 hours was higher (one study; 147 women RR 4.38, 95% CI 1.74 to 10.98), with no increase in caesarean sections (RR 1.19, 95% CI 0.62-2.29). Compared with intracervical PGE2 (14 studies;1784 women and misoprostol there was no significant difference in the proportion of women not achieving vaginal delivery within 24 hours.
Mechanical methods reduced the risk of hyperstimulation with fetal heart rate changes when compared with vaginal prostaglandins: vaginal PGE2 (eight studies; 1203 women, RR 0.16; 95% CI 0.06 to 0.39) and misoprostol (3% versus 9%) (nine studies; 1615 women, RR 0.37; 95% CI 0.25 to 0.54). Risk of caesarean section between mechanical methods and prostaglandins was comparable. Serious neonatal and maternal morbidity were infrequently reported and did not differ between the groups.
Mechanical methods compared with induction with oxytocin (reduced the risk of caesarean section (five studies; 398 women, RR 0.62; 95% CI 0.42 to 0.90). The likelihood of vaginal delivery within 24 hours was not reported. Hyperstimulation with fetal heart rate changes was reported in one study (200 participants), and did not differ. There were no reported cases of severe maternal or neonatal morbidity.
Authors' conclusions
Induction of labour using mechanical methods results in similar caesarean section rates as prostaglandins, for a lower risk of hyperstimulation. Mechanical methods do not increase the overall number of women not delivered within 24 hours, however the proportion of multiparous women who did not achieve vaginal delivery within 24 hours was higher when compared with vaginal PGE2. Compared with oxytocin, mechanical methods reduce the risk of caesarean section.
470 citations