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The Cochrane Database of Systematic... Jul 2013A major cause of failure to achieve spontaneous vaginal birth is delay in labour due to presumed inefficient uterine action. Oxytocin is given to increase contractions... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A major cause of failure to achieve spontaneous vaginal birth is delay in labour due to presumed inefficient uterine action. Oxytocin is given to increase contractions and high-dose regimens may potentially increase the number of spontaneous vaginal births, but as oxytocin can cause hyperstimulation of the uterus, there is a possibility of increased adverse events.
OBJECTIVES
To compare starting dose and increment dose of oxytocin for augmentation for women delayed in labour to determine whether augmentation by high-dose regimens of oxytocin improves labour outcomes and to examine the effect on both maternal/neonatal outcomes and women's birth experiences.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2013) and reference lists of retrieved studies.
SELECTION CRITERIA
We included all randomised and quasi-randomised controlled trials for women in delayed labour requiring augmentation by oxytocin comparing high-dose regimens (defined as starting dose and increment of equal to or more than 4 mU per minute) with low-dose regimens (defined as starting dose and an increment of less than 4 mU per minute). Increase interval: between 15 and 40 minutes. The separation of low- and high-dose regimens is based on an arbitrary decision.
DATA COLLECTION AND ANALYSIS
Four review authors undertook assessment of trial eligibility, risk of bias, and data extraction independently.
MAIN RESULTS
We included four studies involving 644 pregnant women. Three studies were randomised controlled trials and one trial was a quasi-randomised study. A higher dose of oxytocin was associated with a significant reduction in length of labour reported from one trial (mean difference (MD) -3.50 hours; 95% confidence interval (CI) -6.38 to -0.62; one trial, 40 women). There was a decrease in the rate of caesarean section (risk ratio (RR) 0.62; 95% CI 0.44 to 0.86 four trials, 644 women) and an increase in the rate of spontaneous vaginal birth in the high-dose group (RR 1.35; 95% CI 1.13 to 1.62, three trials, 444 women), although for both of these outcomes there were inconsistencies between studies in the size of effect. When we carried out sensitivity analysis (temporarily removing a study at high risk of bias) the differences between groups were no longer statistically significantThere were no significant differences between high- and low-dose regimens for instrumental vaginal birth, epidural analgesia, hyperstimulation, postpartum haemorrhage, chorioamnionitis or women's perceptions of experiences. For neonatal outcomes, there was no significant difference between groups for Apgar scores, umbilical cord pH, admission to special care baby unit, or neonatal mortality. The following outcomes were not evaluated in the included studies: perinatal mortality, uterine rupture, abnormal cardiotocography, women's pyrexia, dystocia and neonatal neurological morbidity.
AUTHORS' CONCLUSIONS
Higher-dose regimens of oxytocin (4 mU per minute or more) were associated with a reduction in the length of labour and in caesarean section, and an increase in spontaneous vaginal birth. However, there is insufficient evidence to recommend that high-dose regimens are advised routinely for women with delay in the first stage of labour. Further research should evaluate the effect of high-dose regimens of oxytocin for women delayed in labour and should include maternal and neonatal outcomes as well as the effects on women.
Topics: Administration, Oral; Cesarean Section; Female; Humans; Labor Stage, First; Labor Stage, Second; Obstetric Labor Complications; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic; Time Factors
PubMed: 23853046
DOI: 10.1002/14651858.CD007201.pub3 -
The Cochrane Database of Systematic... Jul 2013The rate of operative deliveries (both caesarean sections, vacuum extractions and forceps), continues to rise throughout the world. These are associated with significant... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The rate of operative deliveries (both caesarean sections, vacuum extractions and forceps), continues to rise throughout the world. These are associated with significant maternal and neonatal morbidity. The most common reasons for operative births in nulliparous women are labour dystocia (failure to progress), and non-reassuring fetal status. Epidural analgesia has been shown to slow the progress of labour, as well as increase the rate of instrumental deliveries. However, it is unclear whether the use of oxytocin in women with epidural analgesia results in a reduction in operative deliveries, and thereby reduces both maternal and fetal morbidity.
OBJECTIVES
To determine whether augmentation of women using epidural analgesia with oxytocin will decrease the incidence of operative deliveries and thereby reduce fetal and maternal morbidity.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2013).
SELECTION CRITERIA
All published and unpublished randomised and quasi-randomised trials that compared augmentation with oxytocin of women in spontaneous labour with epidural analgesia versus intent to manage expectantly were included. Cluster-randomised trials were eligible for inclusion but none were identified.Cross-over study designs were unlikely to be relevant for this intervention, and we planned to exclude them if any were identified. We did not include results that were only available in published abstracts.
DATA COLLECTION AND ANALYSIS
The two review authors independently assessed for inclusion the 16 studies identified as a result of the search strategy. Both review authors independently assessed the risk of bias for each included study. Both review authors independently extracted data. Data were checked for accuracy.
MAIN RESULTS
We included two studies, involving 319 women. There was no statistically significant difference between the two groups in either of the primary outcomes of caesarean section (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.42 to 2.12) or instrumental delivery (RR 0.88, 95% CI 0.72 to 1.08). Similarly, there were no statistically significant differences between the two groups in any of the secondary outcomes for which data were available. This included Apgar score less than seven at five minutes (RR 3.06, 0.13 to 73.33), admission to neonatal intensive care unit (RR 1.07, 95% CI 0.29 to 3.93), uterine hyperstimulation (RR 1.32, 95% CI 0.97 to 1.80) and postpartum haemorrhage (RR 0.96, 95% CI 0.58, 1.59).
AUTHORS' CONCLUSIONS
There was no statistically significant difference identified between women in spontaneous labour with epidural analgesia who were augmented with oxytocin, compared with those who received placebo. However, due to the limited number of women included in the studies, further research in the form of randomised controlled trials are required.
Topics: Analgesia, Epidural; Analgesia, Obstetrical; Cesarean Section; Dystocia; Extraction, Obstetrical; Female; Humans; Labor, Obstetric; Obstetrical Forceps; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 23846738
DOI: 10.1002/14651858.CD009241.pub3 -
Annals of Internal Medicine Jul 2013Outcomes of treating gestational diabetes mellitus (GDM) are not well-established. (Meta-Analysis)
Meta-Analysis Review
Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research.
BACKGROUND
Outcomes of treating gestational diabetes mellitus (GDM) are not well-established.
PURPOSE
To summarize evidence about the maternal and neonatal benefits and harms of treating GDM.
DATA SOURCES
15 electronic databases from 1995 to May 2012, gray literature, Web sites of relevant organizations, trial registries, and reference lists.
STUDY SELECTION
English-language randomized, controlled trials (n = 5) and cohort studies (n = 6) of women without known preexisting diabetes.
DATA EXTRACTION
One reviewer extracted data, and a second reviewer verified them. Two reviewers independently assessed methodological quality and evaluated strength of evidence for primary outcomes by using a Grading of Recommendations Assessment, Development and Evaluation approach.
DATA SYNTHESIS
All studies compared diet modification, glucose monitoring, and insulin as needed with no treatment. Women who were treated had more prenatal visits than those in control groups. Moderate evidence showed fewer cases of preeclampsia, shoulder dystocia, and macrosomia in the treated group. Evidence was insufficient for maternal weight gain and birth injury. Low evidence showed no difference between groups for neonatal hypoglycemia. Evidence was insufficient for long-term metabolic outcomes among offspring. No difference was found for cesarean delivery (low evidence), induction of labor (insufficient evidence), small-for-gestational-age neonates (moderate evidence), or admission to a neonatal intensive care unit (low evidence).
LIMITATIONS
Evidence is low or insufficient for many outcomes of greatest clinical importance. The strongest evidence supports reductions in intermediate outcomes; however, other factors (for example, maternal weight and gestational weight gain) may impart greater risk than GDM, particularly when glucose levels are modestly elevated.
CONCLUSION
Treating GDM results in less preeclampsia, shoulder dystocia, and macrosomia; however, current evidence does not show an effect on neonatal hypoglycemia or future poor metabolic outcomes. There is little evidence of short-term harm of treating GDM other than an increased demand for services.
Topics: Blood Glucose; Diabetes, Gestational; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Infant, Newborn; Insulin; Pregnancy; Pregnancy Outcome; Risk Assessment
PubMed: 23712381
DOI: 10.7326/0003-4819-159-2-201307160-00661 -
The Cochrane Database of Systematic... Sep 2012Caesarean section rates are over 20% in many developed countries. The main diagnosis contributing to the high rate in nulliparae is dystocia or prolonged labour. The... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Caesarean section rates are over 20% in many developed countries. The main diagnosis contributing to the high rate in nulliparae is dystocia or prolonged labour. The present review assesses the effects of a policy of early amniotomy with early oxytocin administration for the prevention of, or the therapy for, delay in labour progress.
OBJECTIVES
To estimate the effects of early augmentation with amniotomy and oxytocin for prevention of, or therapy for, delay in labour progress on the caesarean birth rate and on indicators of maternal and neonatal morbidity.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (15 February 2012), MEDLINE (1966 to 15 February 2012), EMBASE (1980 to 15 February 2012), CINAHL (1982 to 15 February 2012), MIDIRS (1985 to February 2012) and contacted authors for data from unpublished trials.
SELECTION CRITERIA
Randomized and quasi-randomized controlled trials that compared oxytocin and amniotomy with expectant management.
DATA COLLECTION AND ANALYSIS
Three review authors extracted data independently. We stratified the analyses into 'Prevention Trials' and 'Therapy Trials' according to the status of the woman at the time of randomization. Participants in the 'Prevention Trials' were unselected women, without slow progress in labour, who were randomized to a policy of early augmentation or to routine care. In 'Treatment Trials' women were eligible if they had an established delay in labour progress.
MAIN RESULTS
For this update, we have included a further two new clinical trials. This updated review includes 14 trials, randomizing a total of 8033 women. The unstratified analysis found early intervention with amniotomy and oxytocin to be associated with a modest reduction in the risk of caesarean section; however, the confidence interval (CI) included the null effect (risk ratio (RR) 0.89; 95% CI 0.79 to 1.01; 14 trials; 8033 women). In prevention trials, early augmentation was associated with a modest reduction in the number of caesarean births (RR 0.87; 95% CI 0.77 to 0.99; 11 trials; 7753). A policy of early amniotomy and early oxytocin was associated with a shortened duration of labour (average mean difference (MD) - 1.28 hours; 95% CI -1.97 to -0.59; eight trials; 4816 women). Sensitivity analyses excluding four trials with a full package of active management did not substantially affect the point estimate for risk of caesarean section (RR 0.87; 95% CI 0.73 to 1.05; 10 trials; 5165 women). We found no other significant effects for the other indicators of maternal or neonatal morbidity.
AUTHORS' CONCLUSIONS
In prevention trials, early intervention with amniotomy and oxytocin appears to be associated with a modest reduction in the rate of caesarean section over standard care.
Topics: Amnion; Cesarean Section; Female; Humans; Labor Stage, First; Obstetric Labor Complications; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic; Time Factors
PubMed: 22972098
DOI: 10.1002/14651858.CD006794.pub3 -
The Cochrane Database of Systematic... Aug 2012The partogram (sometimes known as partograph) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partogram is to provide a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The partogram (sometimes known as partograph) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partogram is to provide a pictorial overview of labour, to alert midwives and obstetricians to deviations in maternal or fetal wellbeing and labour progress. Charts often contain pre-printed alert and action lines. An alert line represents the slowest 10% of primigravid women's labour progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour.
OBJECTIVES
To determine the effect of use of partogram on perinatal and maternal morbidity and mortality. To determine the effect of partogram design on perinatal and maternal morbidity and mortality.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2012).
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials involving a comparison of partogram with no partogram, or comparison between different partogram designs.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining authors assessed the studies independently.
MAIN RESULTS
We have included six studies involving 7706 women in this review; two studies assessed partogram versus no partogram and the remainder assessed different partogram designs. There was no evidence of any difference between partogram and no partogram in caesarean section (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.24 to 1.70); instrumental vaginal delivery (RR 1.00, 95% CI 0.85 to 1.17) or Apgar score less than seven at five minutes (RR 0.77, 95% CI 0.29 to 2.06) between the groups. When compared to a four-hour action line, women in the two-hour action line group were more likely to require oxytocin augmentation (RR 1.14, 95% CI 1.05 to 1.22). When the three- and four-hour action line groups were compared, caesarean section rate was lowest in the four-hour action line group and this difference was statistically significant (RR 1.70, 95% CI 1.07 to 2.70, n = 613, one trial). When a partogram with a latent phase (composite) and one without (modified) were compared, the caesarean section rate was lower in the partograph without a latent phase (RR 2.45, 95% CI 1.72 to 3.50, n = 743, one trial).
AUTHORS' CONCLUSIONS
On the basis of the findings of this review, we cannot recommend routine use of the partogram as part of standard labour management and care. Given the fact that the partogram is currently in widespread use and generally accepted, it appears reasonable, until stronger evidence is available, that partogram use should be locally determined. Further trial evidence is required to establish the efficacy of partogram use.
Topics: Cesarean Section; Delivery, Obstetric; Female; Humans; Labor, Obstetric; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic; Term Birth; Uterine Inertia; Uterine Monitoring
PubMed: 22895950
DOI: 10.1002/14651858.CD005461.pub3 -
Health Technology Assessment... Jul 2012Around 50% of women of childbearing age are either overweight [body mass index (BMI) 25-29.9 kg/m(2)] or obese (BMI ≥ 30 kg/m(2)). The antenatal period provides an... (Review)
Review
BACKGROUND
Around 50% of women of childbearing age are either overweight [body mass index (BMI) 25-29.9 kg/m(2)] or obese (BMI ≥ 30 kg/m(2)). The antenatal period provides an opportunity to manage weight in pregnancy. This has the potential to reduce maternal and fetal complications associated with excess weight gain and obesity.
OBJECTIVES
To evaluate the effectiveness of dietary and lifestyle interventions in reducing or preventing obesity in pregnancy and to assess the beneficial and adverse effects of the interventions on obstetric, fetal and neonatal outcomes.
DATA SOURCES
Major electronic databases including MEDLINE, EMBASE, BIOSIS and Science Citation Index were searched (1950 until March 2011) to identify relevant citations. Language restrictions were not applied.
REVIEW METHODS
Systematic reviews of the effectiveness and harm of the interventions were carried out using a methodology in line with current recommendations. Studies that evaluated any dietary, physical activity or mixed approach intervention with the potential to influence weight change in pregnancy were included. The quality of the studies was assessed using accepted contemporary standards. Results were summarised as pooled relative risks (RRs) with 95% confidence intervals (CIs) for dichotomous data. Continuous data were summarised as mean difference (MD) with standard deviation. The quality of the overall evidence synthesised for each outcome was summarised using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology and reported graphically as a two-dimensional chart.
RESULTS
A total of 88 studies (40 randomised and 48 non-randomised and observational studies, involving 182,139 women) evaluated the effect of weight management interventions in pregnancy on maternal and fetal outcomes. Twenty-six studies involving 468,858 women reported the adverse effect of the interventions. Meta-analysis of 30 RCTs (4503 women) showed a reduction in weight gain in the intervention group of 0.97 kg compared with the control group (95% CI -1.60 kg to -0.34 kg; p = 0.003). Weight management interventions overall in pregnancy resulted in a significant reduction in the incidence of pre-eclampsia (RR 0.74, 95% CI 0.59 to 0.92; p = 0.008) and shoulder dystocia (RR 0.39, 95% CI 0.22 to 0.70; p = 0.02). Dietary interventions in pregnancy resulted in a significant decrease in the risk of pre-eclampsia (RR 0.67, 95% CI 0.53 to 0.85; p = 0.0009), gestational hypertension (RR 0.30, 95% CI 0.10 to 0.88; p = 0.03) and preterm birth (RR 0.68, 95% CI 0.48 to 0.96; p = 0.03) and showed a trend in reducing the incidence of gestational diabetes (RR 0.52, 95% CI 0.27 to 1.03). There were no differences in the incidence of small-for-gestational-age infants between the groups (RR 0.99, 95% CI 0.76 to 1.29). There were no significant maternal or fetal adverse effects observed for the interventions in the included trials. The overall strength of evidence for weight gain in pregnancy and birthweight was moderate for all interventions considered together. There was high-quality evidence for small-for-gestational-age infants as an outcome. The quality of evidence for all interventions on pregnancy outcomes was very low to moderate. The quality of evidence for all adverse outcomes was very low.
LIMITATIONS
The included studies varied in the reporting of population, intensity, type and frequency of intervention and patient complience, limiting the interpretation of the findings. There was significant heterogeneity for the beneficial effect of diet on gestational weight gain.
CONCLUSIONS
Interventions in pregnancy to manage weight result in a significant reduction in weight gain in pregnancy (evidence quality was moderate). Dietary interventions are the most effective type of intervention in pregnancy in reducing gestational weight gain and the risks of pre-eclampsia, gestational hypertension and shoulder dystocia. There is no evidence of harm as a result of the dietary and physical activity-based interventions in pregnancy. Individual patient data meta-analysis is needed to provide robust evidence on the differential effect of intervention in various groups based on BMI, age, parity, socioeconomic status and medical conditions in pregnancy.
Topics: Databases, Bibliographic; Feeding Behavior; Female; Humans; Life Style; Motor Activity; Obesity; Outcome Assessment, Health Care; Pregnancy; Pregnancy Complications; Pregnancy Outcome
PubMed: 22814301
DOI: 10.3310/hta16310 -
BMJ (Clinical Research Ed.) May 2012To evaluate the effects of dietary and lifestyle interventions in pregnancy on maternal and fetal weight and to quantify the effects of these interventions on obstetric... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the effects of dietary and lifestyle interventions in pregnancy on maternal and fetal weight and to quantify the effects of these interventions on obstetric outcomes.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Major databases from inception to January 2012 without language restrictions.
STUDY SELECTION
Randomised controlled trials that evaluated any dietary or lifestyle interventions with potential to influence maternal weight during pregnancy and outcomes of pregnancy.
DATA SYNTHESIS
Results summarised as relative risks for dichotomous data and mean differences for continuous data.
RESULTS
We identified 44 relevant randomised controlled trials (7278 women) evaluating three categories of interventions: diet, physical activity, and a mixed approach. Overall, there was 1.42 kg reduction (95% confidence interval 0.95 to 1.89 kg) in gestational weight gain with any intervention compared with control. With all interventions combined, there were no significant differences in birth weight (mean difference -50 g, -100 to 0 g) and the incidence of large for gestational age (relative risk 0.85, 0.66 to 1.09) or small for gestational age (1.00, 0.78 to 1.28) babies between the groups, though by itself physical activity was associated with reduced birth weight (mean difference -60 g, -120 to -10 g). Interventions were associated with a reduced the risk of pre-eclampsia (0.74, 0.60 to 0.92) and shoulder dystocia (0.39, 0.22 to 0.70), with no significant effect on other critically important outcomes. Dietary intervention resulted in the largest reduction in maternal gestational weight gain (3.84 kg, 2.45 to 5.22 kg), with improved pregnancy outcomes compared with other interventions. The overall evidence rating was low to very low for important outcomes such as pre-eclampsia, gestational diabetes, gestational hypertension, and preterm delivery.
CONCLUSIONS
Dietary and lifestyle interventions in pregnancy can reduce maternal gestational weight gain and improve outcomes for both mother and baby. Among the interventions, those based on diet are the most effective and are associated with reductions in maternal gestational weight gain and improved obstetric outcomes.
Topics: Body Mass Index; Body Weight; Confidence Intervals; Diet, Reducing; Female; Humans; Infant, Newborn; Motor Activity; Obesity; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Premature Birth; Randomized Controlled Trials as Topic; Risk Factors; Risk Reduction Behavior; Weight Loss
PubMed: 22596383
DOI: 10.1136/bmj.e2088 -
BMJ (Clinical Research Ed.) Apr 2010To summarise the benefits and harms of treatments for women with gestational diabetes mellitus. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To summarise the benefits and harms of treatments for women with gestational diabetes mellitus.
DESIGN
Systematic review and meta-analysis of randomised controlled trials.
DATA SOURCES
Embase, Medline, AMED, BIOSIS, CCMed, CDMS, CDSR, CENTRAL, CINAHL, DARE, HTA, NHS EED, Heclinet, SciSearch, several publishers' databases, and reference lists of relevant secondary literature up to October 2009. Review methods Included studies were randomised controlled trials of specific treatment for gestational diabetes compared with usual care or "intensified" compared with "less intensified" specific treatment.
RESULTS
Five randomised controlled trials matched the inclusion criteria for specific versus usual treatment. All studies used a two step approach with a 50 g glucose challenge test or screening for risk factors, or both, and a subsequent 75 g or 100 g oral glucose tolerance test. Meta-analyses did not show significant differences for most single end points judged to be of direct clinical importance. In women specifically treated for gestational diabetes, shoulder dystocia was significantly less common (odds ratio 0.40, 95% confidence interval 0.21 to 0.75), and one randomised controlled trial reported a significant reduction of pre-eclampsia (2.5 v 5.5%, P=0.02). For the surrogate end point of large for gestational age infants, the odds ratio was 0.48 (0.38 to 0.62). In the 13 randomised controlled trials of different intensities of specific treatments, meta-analysis showed a significant reduction of shoulder dystocia in women with more intensive treatment (0.31, 0.14 to 0.70).
CONCLUSIONS
Treatment for gestational diabetes, consisting of treatment to lower blood glucose concentration alone or with special obstetric care, seems to lower the risk for some perinatal complications. Decisions regarding treatment should take into account that the evidence of benefit is derived from trials for which women were selected with a two step strategy (glucose challenge test/screening for risk factors and oral glucose tolerance test).
Topics: Bias; Critical Care; Diabetes, Gestational; Female; Humans; Pregnancy; Pregnancy Outcome; Prenatal Care; Randomized Controlled Trials as Topic
PubMed: 20360215
DOI: 10.1136/bmj.c1395 -
The Cochrane Database of Systematic... Jul 2009Gestational diabetes (GDM) affects 3% to 6% of all pregnancies. Women are often intensively managed with increased obstetric monitoring, dietary regulation, and insulin.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Gestational diabetes (GDM) affects 3% to 6% of all pregnancies. Women are often intensively managed with increased obstetric monitoring, dietary regulation, and insulin. However, there has been no sound evidence base to support intensive treatment. The key issue for clinicians and consumers is whether treatment of GDM improves perinatal outcome.
OBJECTIVES
To compare the effect of alternative treatment policies for GDM on both maternal and infant outcomes.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2009) and bibliographies of relevant papers.
SELECTION CRITERIA
Randomised controlled trials comparing alternative management strategies for women with GDM and impaired glucose tolerance in pregnancy.
DATA COLLECTION AND ANALYSIS
Two authors and a member of the Cochrane Pregnancy and Childbirth Group's editorial team extracted and checked data independently. Disagreements were resolved through discussion with the third author.
MAIN RESULTS
Eight randomised controlled trials (1418 women) were included.Caesarean section rate was not significantly different when comparing any specific treatment with routine antenatal care (ANC) including data from five trials with 1255 participants (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.80 to 1.12). However, when comparing oral hypoglycaemics with insulin as treatment for GDM, there was a significant reduction (RR 0.46, 95% CI 0.27 to 0.77, two trials, 90 participants). There was a reduction in the risk of pre-eclampsia with intensive treatment (including dietary advice and insulin) compared to routine ANC (RR 0.65, 95% CI 0.48 to 0.88, one trial, 1000 participants). More women had their labours induced when given specific treatment compared to routine ANC (RR 1.33, 95% CI 1.13 to 1.57, two trials, 1068 participants). The composite outcome of perinatal morbidity (death, shoulder dystocia, bone fracture and nerve palsy) was significantly reduced for those receiving intensive treatment for mild GDM compared to routine ANC (RR 0.32, 95% CI 0.14 to 0.73, one trial, 1030 infants).There was a reduction in the proportion of infants weighing more than 4000 grams (RR 0.46, 95% CI 0.34 to 0.63, one trial, 1030 infants) and the proportion of infants weighing greater than the 90th birth centile (RR 0.55, 95% CI 0.30 to 0.99, three trials, 223 infants) of mothers receiving specific treatment for GDM compared to routine ANC. However, there was no statistically significant difference in this proportion between infants of mothers receiving oral drugs compared to insulin as treatment for GDM.
AUTHORS' CONCLUSIONS
Specific treatment including dietary advice and insulin for mild GDM reduces the risk of maternal and perinatal morbidity. However, it is associated with higher risk of labour induction. More research is needed to assess the impact of different types of intensive treatment, including oral drugs and insulin, on individual short- and long-term infant outcomes.
Topics: Blood Glucose; Diabetes, Gestational; Female; Glucose Tolerance Test; Humans; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic
PubMed: 19588341
DOI: 10.1002/14651858.CD003395.pub2 -
Evidence Report/technology Assessment Mar 2009Induction of labor is on the rise in the U.S., increasing from 9.5 percent in 1990 to 22.1 percent in 2004. Although, it is not entirely clear what proportion of these... (Review)
Review
BACKGROUND
Induction of labor is on the rise in the U.S., increasing from 9.5 percent in 1990 to 22.1 percent in 2004. Although, it is not entirely clear what proportion of these inductions are elective (i.e. without a medical indication), the overall rate of induction of labor is rising faster than the rate of pregnancy complications that would lead to a medically indicated induction. However, the maternal and neonatal effects of induction of labor are unclear. Many studies compare women with induction of labor to those in spontaneous labor. This is problematic, because at any point in the management of the woman with a term gestation, the clinician has the choice between induction of labor and expectant management, not spontaneous labor. Expectant management of the pregnancy involves nonintervention at any particular point in time and allowing the pregnancy to progress to a future gestational age. Thus, women undergoing expectant management may go into spontaneous labor or may require indicated induction of labor at a future gestational age.
OBJECTIVES
The Stanford-UCSF Evidence-Based Practice Center examined the evidence regarding four Key Questions: What evidence describes the maternal risks of elective induction versus expectant management? What evidence describes the fetal/neonatal risks of elective induction versus expectant management? What is the evidence that certain physical conditions/patient characteristics are predictive of a successful induction of labor? How is a failed induction defined?
METHODS
We performed a systematic review to answer the Key Questions. We searched MEDLINE(1966-2007) and bibliographies of prior systematic reviews and the included studies for English language studies of maternal and fetal outcomes after elective induction of labor. We evaluated the quality of included studies. When possible, we synthesized study data using random effects models. We also evaluated the potential clinical outcomes and cost-effectiveness of elective induction of labor versus expectant management of pregnancy labor at 41, 40, and 39 weeks' gestation using decision-analytic models.
RESULTS
Our searches identified 3,722 potentially relevant articles, of which 76 articles met inclusion criteria. Nine RCTs compared expectant management with elective induction of labor. We found that overall, expectant management of pregnancy was associated with an approximately 22 percent higher odds of cesarean delivery than elective induction of labor (OR 1.22, 95 percent CI 1.07-1.39; absolute risk difference 1.9, 95 percent CI: 0.2-3.7 percent). The majority of these studies were in women at or beyond 41 weeks of gestation (OR 1.21, 95 percent CI 1.01-1.46). In studies of women at or beyond 41 weeks of gestation, the evidence was rated as moderate because of the size and number of studies and consistency of the findings. Among women less than 41 weeks of gestation, there were three trials which reported no difference in risk of cesarean delivery among women who were induced as compared to expectant management (OR 1.73; 95 percent CI: 0.67-4.5, P=0.26), but all of these trials were small, non-U.S., older, and of poor quality. When we stratified the analysis by country, we found that the odds of cesarean delivery were higher in women who were expectantly managed compared to elective induction of labor in studies conducted outside the U.S. (OR 1.22; 95 percent CI 1.05-1.40) but were not statistically different in studies conducted in the U.S. (OR 1.28; 95 percent CI 0.65-2.49). Women who were expectantly managed were also more likely to have meconium-stained amniotic fluid than those who were electively induced (OR 2.04; 95 percent CI: 1.34-3.09). Observational studies reported a consistently lower risk of cesarean delivery among women who underwent spontaneous labor (6 percent) compared with women who had an elective induction of labor (8 percent) with a statistically significant decrease when combined (OR 0.63; 95 percent CI: 0.49-0.79), but again utilized the wrong control group and did not appropriately adjust for gestational age. We found moderate to high quality evidence that increased parity, a more favorable cervical status as assessed by a higher Bishop score, and decreased gestational age were associated with successful labor induction (58 percent of the included studies defined success as achieving a vaginal delivery anytime after the onset of the induction of labor; in these instances, induction was considered a failure when it led to a cesarean delivery). In the decision analytic model, we utilized a baseline assumption of no difference in cesarean delivery between the two arms as there was no statistically significant difference in the U.S. studies or in women prior to 41 0/7 weeks of gestation. In each of the models, women who were electively induced had better overall outcomes among both mothers and neonates as estimated by total quality-adjusted life years (QALYs) as well as by reduction in specific perinatal outcomes such as shoulder dystocia, meconium aspiration syndrome, and preeclampsia. Additionally, induction of labor was cost-effective at $10,789 per QALY with elective induction of labor at 41 weeks of gestation, $9,932 per QALY at 40 weeks of gestation, and $20,222 per QALY at 39 weeks of gestation utilizing a cost-effectiveness threshold of $50,000 per QALY. At 41 weeks of gestation, these results were generally robust to variations in the assumed ranges in univariate and multi-way sensitivity analyses. However, the findings of cost-effectiveness at 40 and 39 weeks of gestation were not robust to the ranges of the assumptions. In addition, the strength of evidence for some model inputs was low, therefore our analyses are exploratory rather than definitive.
CONCLUSIONS
Randomized controlled trials suggest that elective induction of labor at 41 weeks of gestation and beyond may be associated with a decrease in both the risk of cesarean delivery and of meconium-stained amniotic fluid. The evidence regarding elective induction of labor prior to 41 weeks of gestation is insufficient to draw any conclusion. There is a paucity of information from prospective RCTs examining other maternal or neonatal outcomes in the setting of elective induction of labor. Observational studies found higher rates of cesarean delivery with elective induction of labor, but compared women undergoing induction of labor to women in spontaneous labor and were subject to potential confounding bias, particularly from gestational age. Such studies do not inform the question of how elective induction of labor affects maternal or neonatal outcomes. Elective induction of labor at 41 weeks of gestation and potentially earlier also appears to be a cost-effective intervention, but because of the need for further data to populate these models our analyses are not definitive. Despite the evidence from the prospective, RCTs reported above, there are concerns about the translation of such findings into actual practice, thus, there is a great need for studying the translation of such research into settings where the majority of obstetric care is provided.
Topics: Cesarean Section; Cost-Benefit Analysis; Female; Gestational Age; Humans; Infant, Newborn; Labor, Induced; Pregnancy; Pregnancy Outcome; Risk Factors
PubMed: 19408970
DOI: No ID Found