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The Cochrane Database of Systematic... Dec 2015Gestational diabetes, glucose intolerance with onset or first recognition during pregnancy, is a rising problem worldwide. Both non-pharmacological and pharmacological... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Gestational diabetes, glucose intolerance with onset or first recognition during pregnancy, is a rising problem worldwide. Both non-pharmacological and pharmacological approaches to the prevention of gestational diabetes have been, and continue to be explored. Myo-inositol, an isomer of inositol, is a naturally occurring sugar commonly found in cereals, corn, legumes and meat. It is one of the intracellular mediators of the insulin signal and correlated with insulin sensitivity in type 2 diabetes. The potential beneficial effect on improving insulin sensitivity suggests that myo-inositol may be useful for women in preventing gestational diabetes.
OBJECTIVES
To assess if antenatal dietary supplementation with myo-inositol is safe and effective, for the mother and fetus, in preventing gestational diabetes.
SEARCH METHODS
We searched the Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, WHO ICTRP (2 November 2015) and reference lists of retrieved studies.
SELECTION CRITERIA
We sought published and unpublished randomised controlled trials, including conference abstracts, assessing the effects of myo-inositol for the prevention of gestational diabetes mellitus (GDM). Quasi-randomised and cross-over trials were not eligible for inclusion, but cluster designs were eligible. Participants in the trials were pregnant women. Women with pre-existing type 1 or type 2 diabetes were excluded. Trials that compared the administration of any dose of myo-inositol, alone or in a combination preparation were eligible for inclusion. Trials that used no treatment, placebo or another intervention as the comparator were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, risk of bias and extracted the data. Data were checked for accuracy.
MAIN RESULTS
We included four randomised controlled trials (all conducted in Italy) reporting on 567 women who were less than 11 weeks' to 24 weeks' pregnant at the start of the trials. The trials had small sample sizes and one trial only reported an interim analysis. Two trials were open-label. The overall risk of bias was unclear.For the mother, supplementation with myo-inositol was associated with a reduction in the incidence of gestational diabetes compared with control (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.29 to 0.64; three trials; n = 502 women). Using GRADE methods this evidence was assessed as low with downgrading due to unclear risk of bias for allocation concealment in two of the included trials and lack of generalisability of findings. For women who received myo-inositol supplementation, the incidence of GDM ranged from 8% to 18%; for women in the control group, the incidence of GDM was 28%, using International Association of Diabetes and Pregnancy Study Groups Consensus Panel 2010 criteria to diagnose GDM.Two trials reported on hypertensive disorders of pregnancy, a primary maternal outcome of this review. There was no clear difference in risk of hypertensive disorders of pregnancy between the myo-inositol and control groups (average RR 0.43, 95% CI 0.02 to 8.41; two trials; n = 398 women; Tau(2) = 3.23; I(2) = 69%). Using GRADE methods, this evidence was assessed as very low, with downgrading due to wide confidence intervals with very low event rates, a small sample size, and lack of blinding and unclear allocation concealment methods, and a lack of generalisability. For women who received myo-inositol the risk of hypertensive disorders of pregnancy ranged from 0% to 33%; for women in the control group the risk was 4%.For the infant, none of the included trials reported on the primary neonatal outcomes of this systematic review (large-for-gestational age, perinatal mortality, mortality or morbidity composite).In terms of this review's secondary outcomes, there was no clear difference in the risk of caesarean section between the myo-inositol and control groups (RR 0.95, 95% CI 0.76 to 1.19; two trials; n = 398 women). Using GRADE methods, this evidence was assessed as low, with downgrading due to unclear risk of bias in one trial and lack of generalisability. For women who received myo-inositol supplementation, the risk of having a caesarean section ranged from 34% to 54%; for women in the control group the was 45%. There were no maternal adverse effects of therapy in the two trials that reported on this outcome (the other two trials did not report this outcome).Two trials found no clear difference in the risk of macrosomia between infants whose mothers received myo-inositol supplementation compared with controls (average RR 0.35, 95% CI 0.02 to 6.37; two trials; n = 398 infants;Tau(2) = 3.33; I(2) = 73%). Similarly, there was no clear difference between groups in terms of neonatal hypoglycaemia (RR 0.36, 95% CI 0.01 to 8.66) or shoulder dystocia (average RR 2.33, 95% CI 0.12 to 44.30, Tau(2) = 3.24; I(2) = 72%).There was a lack of data available for a large number of maternal and neonatal secondary outcomes, and no data for any of the long-term childhood or adulthood outcomes, or for health service cost outcomes.
AUTHORS' CONCLUSIONS
Evidence from four trials of antenatal dietary supplementation with myo-inositol during pregnancy shows a potential benefit for reducing the incidence of gestational diabetes. No data were reported for any of this review's primary neonatal outcomes. There were very little outcome data for the majority of this review's secondary outcomes. There is no clear evidence of a difference for macrosomia when compared with control.The current evidence is based on small trials that are not powered to detect differences in outcomes including perinatal mortality and serious infant morbidity. All of the included studies were conducted in Italy which raises concerns about the lack of generalisability of the evidence to other settings. There is evidence of inconsistency and indirectness and as a result, many of the judgements on the quality of the evidence were downgraded to low or very low quality (GRADEpro Guideline Development Tool).Further trials for this promising antenatal intervention for preventing gestational diabetes are encouraged and should include pregnant women of different ethnicities and varying risk factors and use of myo-inositol (different doses, frequency and timing of administration) in comparison with placebo, diet and exercise or pharmacological interventions. Outcomes should include potential harms including adverse effects.
Topics: Diabetes, Gestational; Female; Humans; Incidence; Inositol; Isomerism; Pregnancy; Prenatal Care; Randomized Controlled Trials as Topic
PubMed: 26678256
DOI: 10.1002/14651858.CD011507.pub2 -
The Cochrane Database of Systematic... Jun 2015This is an update of a Cochrane review first published in 2012, Issue 4. Excessive weight gain during pregnancy is associated with poor maternal and neonatal outcomes... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an update of a Cochrane review first published in 2012, Issue 4. Excessive weight gain during pregnancy is associated with poor maternal and neonatal outcomes including gestational diabetes, hypertension, caesarean section, macrosomia, and stillbirth. Diet or exercise interventions, or both, may reduce excessive gestational weight gain (GWG) and associated poor outcomes; however, evidence from the original review was inconclusive.
OBJECTIVES
To evaluate the effectiveness of diet or exercise, or both, interventions for preventing excessive weight gain during pregnancy and associated pregnancy complications.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (5 November 2014), contacted investigators of the previously identified ongoing studies and scanned reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of diet or exercise, or both, interventions for preventing excessive weight gain in pregnancy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We organised RCTs according to the type of interventions and pooled data using the random-effects model in the Review Manager software. We also performed subgroup analyses according to the initial risk of adverse effects related to poor weight control. We performed sensitivity analysis to assess the robustness of the findings.
MAIN RESULTS
We included 65 RCTs, out of which 49 RCTs involving 11,444 women contributed data to quantitative meta-analysis. Twenty studies were at moderate-to-high risk of bias. Study interventions involved mainly diet only, exercise only, and combined diet and exercise interventions, usually compared with standard care. Study methods varied widely; therefore, we estimated the average effect across studies and performed sensitivity analysis, where appropriate, by excluding outliers and studies at high risk of bias.Diet or exercise, or both, interventions reduced the risk of excessive GWG on average by 20% overall (average risk ratio (RR) 0.80, 95% confidence interval (CI) 0.73 to 0.87; participants = 7096; studies = 24; I² = 52%). This estimate was robust to sensitivity analysis, which reduced heterogeneity, therefore we graded this evidence as high-quality. Interventions involving low glycaemic load diets, supervised or unsupervised exercise only, or diet and exercise combined all led to similar reductions in the number of women gaining excessive weight in pregnancy.Women receiving diet or exercise, or both interventions were more likely to experience low GWG than those in control groups (average RR 1.14, 95% CI 1.02 to 1.27; participants = 4422; studies = 11; I² = 3%; moderate-quality evidence). We found no difference between intervention and control groups with regard to pre-eclampsia (RR 0.95, 95% CI 0.77 to 1.16; participants = 5330; studies = 15; I² = 0%; high-quality evidence); however, maternal hypertension (not a pre-specified outcome) was reduced in the intervention group compared with the control group overall (average RR 0.70, 95% CI 0.51 to 0.96; participants = 5162; studies = 11; I² = 43%; low-quality evidence).There was no clear difference between groups with regard to caesarean delivery overall (RR 0.95, 95% CI 0.88 to 1.03; participants = 7534; studies = 28; I² = 9%; high-quality evidence); although the effect estimate suggested a small difference (5%) in favour of the interventions. In addition, for combined diet and exercise counselling interventions there was a 13% (-1% to 25%) reduction in this outcome (borderline statistical significance).We found no difference between groups with regard to preterm birth overall (average RR 0.91, 95% CI 0.68 to 1.22; participants = 5923; studies = 16; I² = 16%; moderate-quality evidence); however limited evidence suggested that these effect estimates may differ according to the types of interventions, with a trend towards an increased risk for exercise-only interventions.We found no clear difference between intervention and control groups with regard to infant macrosomia (average RR 0.93, 95% CI 0.86 to 1.02; participants = 8598; studies = 27; I² = 0%; high-quality evidence), although the effect estimate suggested a small difference (7% reduction) in favour of the intervention group. The largest effect size occurred in the supervised exercise-only intervention group (RR 0.81, 95% CI 0.64 to 1.02; participants = 2445; studies = 7; I² = 0%), which approached statistical significance (P = 0.07). Furthermore, in subgroup analysis by risk, high-risk women (overweight or obese women, or women with or at risk of gestational diabetes) receiving combined diet and exercise counselling interventions experienced a 15% reduced risk of infant macrosomia (average RR 0.85, 95% CI 0.73 to 1.00; participants = 3252; studies = nine; I² = 0; P = 0.05; moderate-quality evidence)There were no differences in the risk of poor neonatal outcomes including shoulder dystocia, neonatal hypoglycaemia, hyperbilirubinaemia, or birth trauma (all moderate-quality evidence) between intervention and control groups; however, infants of high-risk women had a reduced risk of respiratory distress syndrome if their mothers were in the intervention group (RR 0.47, 95% CI 0.26 to 0.85; participants = 2256; studies = two; I² = 0%; moderate-quality evidence).
AUTHORS' CONCLUSIONS
High-quality evidence indicates that diet or exercise, or both, during pregnancy can reduce the risk of excessive GWG. Other benefits may include a lower risk of caesarean delivery, macrosomia, and neonatal respiratory morbidity, particularly for high-risk women receiving combined diet and exercise interventions. Maternal hypertension may also be reduced. Exercise appears to be an important part of controlling weight gain in pregnancy and more research is needed to establish safe guidelines. Most included studies were carried out in developed countries and it is not clear whether these results are widely applicable to lower income settings.
Topics: Counseling; Diet; Exercise; Female; Humans; Infant, Newborn; Overweight; Pregnancy; Pregnancy Complications; Randomized Controlled Trials as Topic; Weight Gain
PubMed: 26068707
DOI: 10.1002/14651858.CD007145.pub3 -
The Cochrane Database of Systematic... Oct 2014The use of conventional cardiotocographic (CTG) monitoring of fetal well-being during labour is associated with an increased caesarean section rate, compared with... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The use of conventional cardiotocographic (CTG) monitoring of fetal well-being during labour is associated with an increased caesarean section rate, compared with intermittent auscultation of the fetal heart rate, resulting in a reduction in neonatal seizures, although no differences in other neonatal outcomes. To improve the sensitivity of this test and therefore reduce the number of caesarean sections performed for nonreassuring fetal status, several additional measures of evaluating fetal well-being have been considered. These have demonstrated some effect on reducing caesarean section rates, for example, fetal scalp blood sampling for pH estimation/lactate measurement. The adaptation of pulse oximetry for use in the unborn fetus could potentially contribute to improved evaluation during labour and therefore lead to a reduction in caesarean sections for nonreassuring fetal status, without any change in neonatal outcomes.
OBJECTIVES
To compare the effectiveness and safety of fetal intrapartum pulse oximetry with other surveillance techniques.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2014), contacted experts in the field and searched reference lists of retrieved studies. In previous versions of this review, we performed additional searches of MEDLINE, Embase and Current Contents. These searches were discontinued for this review update, as they consistently failed to identify any trials that were not shown in the Cochrane Pregnancy and Childbirth Group's Trials Register.
SELECTION CRITERIA
All published and unpublished randomised controlled trials that compared maternal and fetal outcomes when fetal pulse oximetry was used in labour, (i) with or without concurrent use of conventional fetal surveillance, that is, cardiotocography (CTG), compared with using CTG alone or (ii) with or without concurrent use of both CTG and other method(s) of fetal surveillance, such as fetal electrocardiography (ECG) plus CTG.
DATA COLLECTION AND ANALYSIS
At least two independent review authors performed data extraction. We sought additional information from the investigators of three of the reported trials.
MAIN RESULTS
We included seven published trials: six comparing fetal pulse oximetry and CTG with CTG alone (or when fetal pulse oximetry values were blinded) and one comparing fetal pulse oximetry plus CTG with fetal ECG plus CTG. The published trials, with some unpublished data, were at high risk of bias in terms of the impractical nature of blinding participants and clinicians, as well as high risk or unclear risk of bias for outcome assessor for all but one report. Selection bias, attrition bias, reporting bias and other sources of bias were of low or unclear risk. The trials reported on a total of 8013 pregnancies. Differing entry criteria necessitated separate analyses, rather than meta-analysis of all trials.Systematic review of four trials from 34 weeks not requiring fetal blood sampling (FBS) prior to study entry showed no evidence of differences in the overall caesarean section rate between those monitored with fetal oximetry and those not monitored with fetal pulse oximetry or for whom the fetal pulse oximetry results were masked (average risk ratio (RR) 0.99 using random-effects, 95% confidence intervals (CI) 0.86 to 1.13, n = 4008, I² = 45%). There was evidence of a higher risk of caesarean section in the group with fetal oximetry plus CTG than in the group with fetal ECG plus CTG (one study, n = 180, RR 1.56, 95% CI 1.06 to 2.29). Neonatal seizures and neonatal encephalopathy were rare in both groups. No studies reported details of long-term disability.There was evidence of a decrease in caesarean section for nonreassuring fetal status in the fetal pulse oximetry plus CTG group compared to the CTG group, gestation from 34 weeks (average RR (random-effects) 0.65, 95% CI 0.46 to 0.90, n = 4008, I² = 63%). There was no evidence of differences between groups in caesarean section for dystocia, although the overall incidence rates varied between the trials.
AUTHORS' CONCLUSIONS
The addition of fetal pulse oximetry does not reduce overall caesarean section rates. One study found a higher caesarean section rate in the group monitored with fetal pulse oximetry plus CTG, compared with fetal ECG plus CTG. The data provide limited support for the use of fetal pulse oximetry when used in the presence of a nonreassuring CTG, to reduce caesarean section for nonreassuring fetal status. A better method than pulse oximetry is required to enhance the overall evaluation of fetal well-being in labour.
Topics: Cardiotocography; Cesarean Section; Delivery, Obstetric; Female; Fetal Monitoring; Humans; Oximetry; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 25287809
DOI: 10.1002/14651858.CD004075.pub4 -
BMC Pregnancy and Childbirth Aug 2014The partograph is a graphic display of the progress of labour, recommended by the World Health Organization, but often underused in practice in low- and middle-income... (Review)
Review
BACKGROUND
The partograph is a graphic display of the progress of labour, recommended by the World Health Organization, but often underused in practice in low- and middle-income countries. We were interested in going beyond demonstration of potential efficacy - on which the existing literature concentrates - through a systematic review to identify barriers to and incentives for achieving partograph use.
METHODS
We searched Ovid MEDLINE, Ovid Maternity and Infant Care, POPLINE, Web of Science, and Scopus, from 1st January 1994 to 30th September 2013, using the term 'partogra*' to include 'partograph', 'partogram', or 'partogramme'. The selection criteria were for primary or secondary research describing barriers to and incentives for partograph use in low- and middle-income countries, in English, reported in peer-reviewed publications since 1994. Thematic analysis of text on partograph use was applied to a commonly used framework for change in clinical practice, with levels describing the innovation, the individual professional, the woman, and social, organisational, economic and political contexts.
RESULTS
Reported barriers to and incentives for partograph use related to the partograph itself, professional skills and practice, clinical leadership and quality assurance, and the organisational environment within the wider provision of obstetric care. Neither the evidence base for its effectiveness, nor its credibility, was reported as a barrier to use.
CONCLUSION
Identifying and addressing local barriers and incentives in low- and middle-income countries, based on those in published research, could inform strategies to improve partograph use. Emerging technologies could be used to address some barriers. The thresholds for essential maternity care at which the partograph adds value should be further evaluated.
Topics: Attitude of Health Personnel; Clinical Competence; Decision Support Techniques; Delivery, Obstetric; Developing Countries; Dystocia; Female; Humans; Labor, Obstetric; Leadership; Organizational Culture; Pregnancy
PubMed: 25132124
DOI: 10.1186/1471-2393-14-281