Background
Beyond term, the risks of stillbirth or neonatal death increase. It is unclear whether a policy of labour induction can reduce these risks. This Cochrane review is an update of a review ...that was originally published in 2006 and subsequently updated in 2012
Objectives
To assess the effects of a policy of labour induction at or beyond term compared with a policy of awaiting spontaneous labour or until an indication for birth induction of labour is identified) on pregnancy outcomes for infant and mother.
Search methods
We searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (9 October 2017), and reference lists of retrieved studies.
Selection criteria
Randomised controlled trials (RCTs) conducted in pregnant women at or beyond term, comparing a policy of labour induction with a policy of awaiting spontaneous onset of labour (expectant management). We also included trials published in form only. Cluster‐RCTs, quasi‐RCTs and trials using a cross‐over design are not eligible for inclusion in this review.
We included pregnant women at or beyond term. Since a risk factor at this stage of pregnancy would normally require an intervention, only trials including women at low risk for complications were eligible. We accepted the trialists' definition of 'low risk'. The trials of induction of labour in women with prelabour rupture of membranes at or beyond term were not considered in this review but are considered in a separate Cochrane review.
Data collection and analysis
Two reviewers independently assessed trials for inclusion, assessed risk of bias and extracted data. Data were checked for accuracy. We assessed the quality of evidence using the GRADE approach.
Main results
In this updated review, we included 30 RCTs (reporting on 12,479 women). The trials took place in Norway, China, Thailand, the USA, Austria, Turkey, Canada, UK, India, Tunisia, Finland, Spain, Sweden and the Netherlands. They were generally at a moderate risk of bias.
Compared with a policy of expectant management, a policy of labour induction was associated with fewer (all‐cause) perinatal deaths (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.14 to 0.78; 20 trials, 9960 infants; moderate‐quality evidence). There were two perinatal deaths in the labour induction policy group compared with 16 perinatal deaths in the expectant management group. The number needed to treat to for an additional beneficial outcome (NNTB) with induction of labour in order to prevent one perinatal death was 426 (95% CI 338 to 1337). There were fewer stillbirths in the induction group (RR 0.33, 95% CI 0.11 to 0.96; 20 trials, 9960 infants; moderate‐quality evidence); there was one stillbirth in the induction policy arm and 10 in the expectant management group.
For women in the policy of induction arms of trials, there were fewer caesarean sections compared with expectant management (RR 0.92, 95% CI 0.85 to 0.99; 27 trials, 11,738 women; moderate‐quality evidence); and a corresponding marginal increase in operative vaginal births with induction (RR 1.07, 95% CI 0.99 to 1.16; 18 trials, 9281 women; moderate‐quality evidence). There was no evidence of a difference between groups for perineal trauma (RR 1.09, 95% CI 0.65 to 1.83; 4 trials; 3028 women; low‐quality evidence), postpartum haemorrhage (RR 1.09 95% CI 0.92 to 1.30, 5 trials; 3315 women; low‐quality evidence), or length of maternal hospital stay (average mean difference (MD) ‐0.34 days, 95% CI ‐1.00 to 0.33; 5 trials; 1146 women; Tau² = 0.49; I² 95%; very low‐quality evidence).
Rates of neonatal intensive care unit (NICU) admission were lower (RR 0.88, 95% CI 0.77 to 1.01; 13 trials, 8531 infants; moderate‐quality evidence) and fewer babies had Apgar scores less than seven at five minutes in the induction groups compared with expectant management (RR 0.70, 95% CI 0.50 to 0.98; 16 trials, 9047 infants; moderate‐quality evidence).
There was no evidence of a difference for neonatal trauma (RR 1.18, 95% CI 0.68 to 2.05; 3 trials, 4255 infants; low‐quality evidence), for induction compared with expectant management.
Neonatal encephalopathy, neurodevelopment at childhood follow‐up, breastfeeding at discharge and postnatal depression were not reported by any trials.
In subgroup analyses, no clear differences between timing of induction (< 41 weeks versus ≥ 41 weeks' gestation) or by state of cervix were seen for perinatal death, stillbirth, NICU admission, caesarean section, or perineal trauma. However, operative vaginal birth was more common in the inductions at < 41 weeks' gestation subgroup compared with inductions at later gestational ages. The majority of trials (about 75% of participants) adopted a policy of induction at ≥ 41 weeks (> 287 days) gestation for the intervention arm.
Authors' conclusions
A policy of labour induction at or beyond term compared with expectant management is associated with fewer perinatal deaths and fewer caesarean sections; but more operative vaginal births. NICU admissions were lower and fewer babies had low Apgar scores with induction. No important differences were seen for most of the other maternal and infant outcomes.
Most of the important outcomes assessed using GRADE had a rating of moderate or low‐quality evidence ‐ with downgrading decisions generally due to study limitations such as lack of blinding (a condition inherent in comparisons between a policy of acting and of waiting), or imprecise effect estimates. One outcome (length of maternal stay) was downgraded further to very low‐quality evidence due to inconsistency.
Although the absolute risk of perinatal death is small, it may be helpful to offer women appropriate counselling to help choose between scheduled induction for a post‐term pregnancy or monitoring without (or later) induction).
The optimal timing of offering induction of labour to women at or beyond term warrants further investigation, as does further exploration of risk profiles of women and their values and preferences. Individual participant meta‐analysis is likely to help elucidate the role of factors, such as parity, in influencing outcomes of induction compared with expectant management.
Background Tighter glycaemic targets may be of benefit for women with GDM and their infants. Barrier and enabler identification prior to implementation of tighter glycaemic targets for women with GDM ...may support a successful transition. Methods A cross-sectional questionnaire survey was conducted among Key Informant Health Professionals in ten hospitals in New Zealand. The survey assessed what was currently working using less tight glycaemic targets; what barriers and enablers were considered likely when introducing tighter glycaemic targets and whether these perceptions differed by health professional groups. Results Sixty Key Health Informant Health Professionals completed the survey. When using the lower glycaemic targets, participants considered that women with GDM found the targets easy to use and that collaborative collegial support was effective. No significant barriers were identified. Perceived enablers identified prior to implementation of tighter targets included receiving collegial support (40, 67%), attending education sessions (38, 63%), use of pocket prompt cards (31, 52%), availability of wall charts (25, 42%) and glycaemic target reminder stickers (24, 40%). For health professionals referring into the Diabetes in Pregnancy Service effective communication (50, 83%) was considered important. Perceived barriers were confusion over glycaemic targets use (27 (45%), not being informed of the glycaemic target change (31, 52%), non-involvement with multidisciplinary decisions (29, 48%) and increased difficulty of blood glucose control for women (48, 80%). Overall, barriers and enablers between Health Professional groups did not differ. Discussion Key Informant Health Professionals reported effective communication as a key perceived enabler and that woman would find it more difficult to control their blood glucose concentrations. Education sessions, multidisciplinary engagement, wall charts and stickers were considered effective to overcome the perceived barriers. Further research is needed to assess if the barriers perceived were realised and if the perceived enablers supported the implementation of the tighter glycaemic targets effectively.
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Treatment for gestational diabetes mellitus (GDM) aims to reduce maternal hyperglycaemia. The TARGET Trial assessed whether tighter compared with less tight glycaemic control reduced maternal and ...perinatal morbidity. In this stepped-wedge, cluster-randomised trial, identification number ACTRN12615000282583, 10 hospitals in New Zealand were randomised to 1 of 5 implementation dates. The trial was registered before the first participant was enrolled. All hospitals initially used less tight targets (fasting plasma glucose (FPG) <5.5 mmol/L (<99 mg/dL), 1-hour <8.0 mmol/L (<144 mg/dL), 2 hour postprandial <7.0 mmol/L (<126 mg/dL)) and every 4 months, 2 hospitals moved to use tighter targets (FPG less than or equal to5.0 mmol/L (less than or equal to90 mg/dL), 1-hour less than or equal to7.4 mmol/L (less than or equal to133 mg/dL), 2 hour postprandial less than or equal to6.7 mmol/L) (less than or equal to121 mg/dL). Women with GDM, blinded to the targets in use, were eligible. The primary outcome was large for gestational age. Secondary outcomes assessed maternal and infant health. Analyses were by intention to treat. Between May 2015 and November 2017, data were collected from 1,100 women with GDM (1,108 infants); 598 women (602 infants) used the tighter targets and 502 women (506 infants) used the less tight targets. The rate of large for gestational age was similar between the treatment target groups (88/599, 14.7% versus 76/502, 15.1%; adjusted relative risk adjRR 0.96, 95% confidence interval CI 0.66 to 1.40, P = 0.839). The composite serious health outcome for the infant of perinatal death, birth trauma, or shoulder dystocia was apparently reduced in the tighter group when adjusted for gestational age at diagnosis of GDM, BMI, ethnicity, and history of GDM compared with the less tight group (8/599, 1.3% versus 13/505, 2.6%, adjRR 0.23, 95% CI 0.06 to 0.88, P = 0.032). No differences were seen for the other infant secondary outcomes apart from a shorter stay in intensive care (P = 0.041). Secondary outcomes for the woman showed an apparent increase for the composite serious health outcome that included major haemorrhage, coagulopathy, embolism, and obstetric complications in the tighter group (35/595, 5.9% versus 15/501, 3.0%, adjRR 2.29, 95% CI 1.14 to 4.59, P = 0.020). There were no differences between the target groups in the risk for pre-eclampsia, induction of labour, or cesarean birth, but more women using tighter targets required pharmacological treatment (404/595, 67.9% versus 293/501, 58.5%, adjRR 1.20, 95% CI 1.00 to 1.44, P = 0.047). The main study limitation is that the treatment targets used may vary to those in use in some countries. Tighter glycaemic targets in women with GDM compared to less tight targets did not reduce the risk of a large for gestational age infant, but did reduce serious infant morbidity, although serious maternal morbidity was increased. These findings can be used to aid decisions on the glycaemic targets women with GDM should use.
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Babies born preterm are at an increased risk of dying in the first weeks of life, and those who survive have a higher rate of cerebral palsy (CP) compared with babies born at term. The aim of this ...individual participant data (IPD) meta-analysis (MA) was to assess the effects of antenatal magnesium sulphate, compared with no magnesium treatment, given to women at risk of preterm birth on important maternal and fetal outcomes, including survival free of CP, and whether effects differed by participant or treatment characteristics such as the reason the woman was at risk of preterm birth, why treatment was given, the gestational age at which magnesium sulphate treatment was received, or the dose and timing of the administration of magnesium sulphate.
Trials in which women considered at risk of preterm birth (<37 weeks' gestation) were randomised to magnesium sulphate or control treatment and where neurologic outcomes for the baby were reported were eligible for inclusion. The primary outcomes were infant death or CP and severe maternal outcome potentially related to treatment. Studies were identified based on the Cochrane Pregnancy and Childbirth search strategy using the terms antenatal or prenatal and magnesium and preterm or premature or neuroprotection or 'cerebral palsy'. The date of the last search was 28 February 2017. IPD were sought from investigators with eligible trials. Risk of bias was assessed using criteria from the Cochrane Collaboration. For each prespecified outcome, IPD were analysed using a 1-stage approach. All 5 trials identified were included, with 5,493 women and 6,131 babies. Overall, there was no clear effect of magnesium sulphate treatment compared with no treatment on the primary infant composite outcome of death or CP (relative risk RR 0.94, 95% confidence interval (CI) 0.85 to 1.05, 6,131 babies, 5 trials, p = 0.07 for heterogeneity of treatment effect across trials). In the prespecified sensitivity analysis restricted to data from the 4 trials in which the intent of treatment was fetal neuroprotection, there was a significant reduction in the risk of death or CP with magnesium sulphate treatment compared with no treatment (RR 0.86, 95% CI 0.75 to 0.99, 4,448 babies, 4 trials), with no significant heterogeneity (p = 0.28). The number needed to treat (NNT) to benefit was 41 women/babies to prevent 1 baby from either dying or having CP. For the primary outcome of severe maternal outcome potentially related to magnesium sulphate treatment, no events were recorded from the 2 trials providing data. When the individual components of the composite infant outcome were assessed, no effect was seen for death overall (RR 1.03, 95% CI 0.91 to 1.17, 6,131 babies, 5 trials) or in the analysis of death using only data from trials with the intent of fetal neuroprotection (RR 0.95, 95% CI 0.80 to 1.13, 4,448 babies, 4 trials). For cerebral palsy in survivors, magnesium sulphate treatment had a strong protective effect in both the overall analysis (RR 0.68, 95% CI 0.54 to 0.87, 4,601 babies, 5 trials, NNT to benefit 46) and the neuroprotective intent analysis (RR 0.68, 95% CI 0.53 to 0.87, 3,988 babies, 4 trials, NNT to benefit 42). No statistically significant differences were seen for any of the other secondary outcomes. The treatment effect varied little by the reason the woman was at risk of preterm birth, the gestational age at which magnesium sulphate treatment was given, the total dose received, or whether maintenance therapy was used. A limitation of the study was that not all trials could provide the data required for the planned analyses so that combined with low event rates for some important clinical events, the power to find a difference was limited.
Antenatal magnesium sulphate given prior to preterm birth for fetal neuroprotection prevents CP and reduces the combined risk of fetal/infant death or CP. Benefit is seen regardless of the reason for preterm birth, with similar effects across a range of preterm gestational ages and different treatment regimens. Widespread adoption worldwide of this relatively inexpensive, easy-to-administer treatment would lead to important global health benefits for infants born preterm.
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Background
Gestational diabetes mellitus (GDM) is associated with a wide range of adverse health consequences for women and their infants in the short and long term. With an increasing prevalence of ...GDM worldwide, there is an urgent need to assess strategies for GDM prevention, such as combined diet and exercise interventions. This is an update of a Cochrane review that was first published in 2015.
Objectives
To assess the effects of diet interventions in combination with exercise interventions for pregnant women for preventing GDM, and associated adverse health consequences for the mother and her infant/child.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 November 2016) and reference lists of retrieved studies.
Selection criteria
We included randomised controlled trials (RCTs) and cluster‐RCTs, comparing combined diet and exercise interventions with no intervention (i.e. standard care), that reported on GDM diagnosis as an outcome. Quasi‐RCTs were excluded. Cross‐over trials were not eligible for inclusion. We planned to include RCTs comparing two or more different diet/exercise interventions, however none were identified.
Data collection and analysis
Two review authors independently assessed study eligibility, extracted data, assessed the risk of bias of the included trials and assessed quality of evidence for selected maternal and infant/child outcomes using the GRADE approach. We checked data for accuracy.
Main results
In this update, we included 23 RCTs (involving 8918 women and 8709 infants) that compared combined diet and exercise interventions with no intervention (standard care). The studies varied in the diet and exercise programs evaluated and health outcomes reported. None reported receiving funding from a drug manufacturer or agency with interests in the results. Overall risk of bias was judged to be unclear due to the lack of methodological detail reported. Most studies were undertaken in high‐income countries.
For our primary review outcomes, there was a possible reduced risk of GDM in the diet and exercise intervention group compared with the standard care group (average risk ratio (RR) 0.85, 95% confidence interval (CI) 0.71 to 1.01; 6633 women; 19 RCTs; Tau² = 0.05; I² = 42%; P = 0.07; moderate‐quality evidence). There was also a possible reduced risk of caesarean section (RR 0.95, 95% CI 0.88 to 1.02; 6089 women; 14 RCTs; moderate‐quality evidence). No clear differences were seen between groups for pre‐eclampsia (RR 0.98, 95% CI 0.79 to 1.22; 5366 participants; 8 RCTs; low‐quality evidence), pregnancy‐induced hypertension and/or hypertension (average RR 0.78, 95% CI 0.47 to 1.27; 3073 participants; 6 RCTs; Tau² = 0.19; I² = 62%; very low‐quality evidence), perinatal mortality (RR 0.82, 95% CI 0.42 to 1.63; 3757 participants; 2 RCTs; low‐quality evidence) or large‐for‐gestational age (RR 0.93, 95% CI 0.81 to 1.07; 5353 participants; 11 RCTs; low‐quality evidence). No data were reported for infant mortality or morbidity composite.
Subgroup analyses (based on trial design, maternal body mass index (BMI) and ethnicity) revealed no clear differential treatment effects. We were unable to assess the impact of maternal age, parity and specific features of the diet and exercise interventions. Findings from sensitivity analyses (based on RCT quality) generally supported those observed in the main analyses. We were not able to perform subgroup analyses based on maternal age, parity or nature of the exercise/dietary interventions due to the paucity of information/data on these characteristics and the inability to meaningfully group intervention characteristics.
For most of the secondary review outcomes assessed using GRADE, there were no clear differences between groups, including for perineal trauma (RR 1.27, 95% CI 0.78 to 2.05; 2733 participants; 2 RCTs; moderate‐quality evidence), neonatal hypoglycaemia (average RR 1.42, 95% CI 0.67 to 2.98; 3653 participants; 2 RCTs; Tau² = 0.23; I² = 77%; low quality evidence); and childhood adiposity (BMI z score) (MD 0.05, 95% CI ‐0.29 to 0.40; 794 participants; 2 RCTs; Tau² = 0.04; I² = 59%; low‐quality evidence). However, there was evidence of less gestational weight gain in the diet and exercise intervention group compared with the control group (mean difference (MD) ‐0.89 kg, 95% CI ‐1.39 to ‐0.40; 5052 women; 16 RCTs; Tau² = 0.37; I² = 43%;moderate‐quality evidence). No data were reported for maternal postnatal depression or type 2 diabetes; childhood/adulthood type 2 diabetes, or neurosensory disability.
Authors' conclusions
Moderate‐quality evidence suggests reduced risks of GDM and caesarean section with combined diet and exercise interventions during pregnancy as well as reductions in gestational weight gain, compared with standard care. There were no clear differences in hypertensive disorders of pregnancy, perinatal mortality, large‐for‐gestational age, perineal trauma, neonatal hypoglycaemia, and childhood adiposity (moderate‐ tovery low‐quality evidence).
Using GRADE methodology, the evidence was assessed as moderate to very low quality. Downgrading decisions were predominantly due to design limitations (risk of bias), and imprecision (uncertain effect estimates, and at times, small sample sizes and low event rates), however two outcomes (pregnancy‐induced hypertension/hypertension and neonatal hypoglycaemia), were also downgraded for unexplained inconsistency (statistical heterogeneity).
Due to the variability of the diet and exercise components tested in the included studies, the evidence in this review has limited ability to inform practice. Future studies could describe the interventions used in more detail, if and how these influenced behaviour change and ideally be standardised between studies. Studies could also consider using existing core outcome sets to facilitate more standardised reporting.
The prevalence of obesity amongst women bearing children in Australia is rising and has important implications for obstetric care. The aim of this study was to assess the prevalence and impact of ...mothers being overweight and obese in early to mid-pregnancy on maternal, peripartum and neonatal outcomes.
A secondary analysis was performed on data collected from nulliparous women with a singleton pregnancy enrolled in the Australian Collaborative Trial of Supplements with antioxidants Vitamin C and Vitamin E to pregnant women for the prevention of pre-eclampsia (ACTS). Women were categorized into three groups according to their body mass index (BMI): normal (BMI 18.5-24.9 kg/m2); overweight (BMI 25-29.9 kg/m2) and; obese (BMI 30-34.9 kg/m2). Obstetric and perinatal outcomes were compared by univariate and multivariate analyses.
Of the 1661 women included, 43% were overweight or obese. Obese women were at increased risk of pre-eclampsia (relative risk (RR) 2.99 95% confidence intervals (CI) 1.88, 4.73, p < 0.0001) and gestational diabetes (RR 2.10 95%CI 1.17, 3.79, p = 0.01) compared with women with a normal BMI. Obese and overweight women were more likely to be induced and require a caesarean section compared with women of normal BMI (induction - RR 1.33 95%CI 1.13, 1.57, p = 0.001 and 1.78 95%CI 1.51, 2.09, p < 0.0001, caesarean section - RR 1.42 95%CI 1.18, 1.70, p = 0.0002 and 1.63 95%CI 1.34, 1.99, p < 0.0001). Babies of women who were obese were more likely to be large for gestational age (LFGA) (RR 2.08 95%CI 1.47, 2.93, p < 0.0001) and macrosomic (RR 4.54 95%CI 2.01, 10.24, p = 0.0003) compared with those of women with a normal BMI.
The rate of overweight and obesity is increasing amongst the Australian obstetric population. Women who are overweight and obese have an increased risk of adverse pregnancy outcomes. In particular, obese women are at increased risk of gestational diabetes, pregnancy induced hypertension and pre-eclampsia. Effective preventative strategies are urgently needed.
Current Controlled Trials ISRCTN00416244.
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Background
Gestational diabetes mellitus (GDM) is a form of diabetes occurring during pregnancy which can result in short‐ and long‐term adverse outcomes for women and babies. With an increasing ...prevalence worldwide, there is a need to assess strategies, including dietary advice interventions, that might prevent GDM.
Objectives
To assess the effects of dietary advice interventions for preventing GDM and associated adverse health outcomes for women and their babies.
Search methods
We searched Cochrane Pregnancy and Childbirth's Trials Register (3 January 2016) and reference lists of retrieved studies.
Selection criteria
Randomised controlled trials (RCTs) and quasi‐RCTs assessing the effects of dietary advice interventions compared with no intervention (standard care), or to different dietary advice interventions. Cluster‐RCTs were eligible for inclusion but none were identified.
Data collection and analysis
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach.
Main results
We included 11 trials involving 2786 women and their babies, with an overall unclear to moderate risk of bias. Six trials compared dietary advice interventions with standard care; four compared low glycaemic index (GI) with moderate‐ to high‐GI dietary advice; one compared specific (high‐fibre focused) with standard dietary advice.
Dietary advice interventions versus standard care (six trials)
Considering primary outcomes, a trend towards a reduction in GDM was observed for women receiving dietary advice compared with standard care (average risk ratio (RR) 0.60, 95% confidence interval (CI) 0.35 to 1.04; five trials, 1279 women; Tau² = 0.20; I² = 56%; P = 0.07; GRADE: very low‐quality evidence); subgroup analysis suggested a greater treatment effect for overweight and obese women receiving dietary advice. While no clear difference was observed for pre‐eclampsia (RR 0.61, 95% CI 0.25 to 1.46; two trials, 282 women; GRADE: low‐quality evidence) a reduction in pregnancy‐induced hypertension was observed for women receiving dietary advice (RR 0.30, 95% CI 0.10 to 0.88; two trials, 282 women; GRADE: low‐quality evidence). One trial reported on perinatal mortality, and no deaths were observed (GRADE: very low‐quality evidence). None of the trials reported on large‐for‐gestational age or neonatal mortality and morbidity.
For secondary outcomes, no clear differences were seen for caesarean section (average RR 0.98, 95% CI 0.78 to 1.24; four trials, 1194 women; Tau² = 0.02; I² = 36%; GRADE: low‐quality evidence) or perineal trauma (RR 0.83, 95% CI 0.23 to 3.08; one trial, 759 women; GRADE: very low‐quality evidence). Women who received dietary advice gained less weight during pregnancy (mean difference (MD) ‐4.70 kg, 95% CI ‐8.07 to ‐1.34; five trials, 1336 women; Tau² = 13.64; I² = 96%; GRADE: low‐quality evidence); the result should be interpreted with some caution due to considerable heterogeneity. No clear differences were seen for the majority of secondary outcomes reported, including childhood/adulthood adiposity (skin‐fold thickness at six months) (MD ‐0.10 mm, 95% CI ‐0.71 to 0.51; one trial, 132 children; GRADE: low‐quality evidence). Women receiving dietary advice had a lower well‐being score between 14 and 28 weeks, more weight loss at three months, and were less likely to have glucose intolerance (one trial).
The trials did not report on other secondary outcomes, particularly those related to long‐term health and health service use and costs. We were not able to assess the following outcomes using GRADE: postnatal depression; maternal type 2 diabetes; neonatal hypoglycaemia; childhood/adulthood type 2 diabetes; and neurosensory disability.
Low‐GI dietary advice versus moderate‐ to high‐GI dietary advice (four trials)
Considering primary outcomes, no clear differences were shown in the risks of GDM (RR 0.91, 95% CI 0.63 to 1.31; four trials, 912 women; GRADE: low‐quality evidence) or large‐for‐gestational age (average RR 0.60, 95% CI 0.19 to 1.86; three trials, 777 babies; Tau² = 0.61; P = 0.07; I² = 62%; GRADE: very low‐quality evidence) between the low‐GI and moderate‐ to high‐GI dietary advice groups. The trials did not report on: hypertensive disorders of pregnancy; perinatal mortality; neonatal mortality and morbidity.
No clear differences were shown for caesarean birth (RR 1.27, 95% CI 0.79 to 2.04; two trials, 201 women; GRADE: very low‐quality evidence) and gestational weight gain (MD ‐1.23 kg, 95% CI ‐4.08 to 1.61; four trials, 787 women; Tau² = 7.31; I² = 90%; GRADE: very low‐quality evidence), or for other reported secondary outcomes.
The trials did not report the majority of secondary outcomes including those related to long‐term health and health service use and costs. We were not able to assess the following outcomes using GRADE: perineal trauma; postnatal depression; maternal type 2 diabetes; neonatal hypoglycaemia; childhood/adulthood adiposity; type 2 diabetes; and neurosensory disability.
High‐fibre dietary advice versus standard dietary advice (one trial)
The one trial in this comparison reported on two secondary outcomes. No clear difference between the high‐fibre and standard dietary advice groups observed for mean blood glucose (following an oral glucose tolerance test at 35 weeks), and birthweight.
Authors' conclusions
Very low‐quality evidence from five trials suggests a possible reduction in GDM risk for women receiving dietary advice versus standard care, and low‐quality evidence from four trials suggests no clear difference for women receiving low‐ versus moderate‐ to high‐GI dietary advice. A possible reduction in pregnancy‐induced hypertension for women receiving dietary advice was observed and no clear differences were seen for other reported primary outcomes. There were few outcome data for secondary outcomes.
For outcomes assessed using GRADE, evidence was considered to be low to very low quality, with downgrading based on study limitations (risk of bias), imprecision, and inconsistency.
More high‐quality evidence is needed to determine the effects of dietary advice interventions in pregnancy. Future trials should be designed to monitor adherence, women's views and preferences, and powered to evaluate effects on short‐ and long‐term outcomes; there is a need for such trials to collect and report on core outcomes for GDM research. We have identified five ongoing studies and four are awaiting classification. We will consider these in the next review update.
The aim of this trial was to determine if midwives or doctor leaders are more effective at implementing a clinical practice guideline for oral dextrose gel to treat neonatal hypoglycaemia. This was a ...cluster-randomised, controlled, trial. New Zealand maternity hospitals were randomised to guideline implementation by a midwife or doctor implementation leader. The primary outcome was the change in the proportion of hypoglycaemic babies (blood glucose concentration <2.6 mmol/L in the first 48 hours after birth), treated with dextrose gel from before, to three months after, implementation. Twenty-one maternity hospitals that cared for babies at risk of hypoglycaemia consented to participate, of which 15 treated babies with hypoglycaemia at both time points (7 randomised to midwifery led, 8 randomised to doctor led implementation). The primary outcome included 463 hypoglycaemic babies (292 midwifery led, 171 doctor led implementation). There was no difference in the primary outcome between hospitals randomised to midwifery or doctor led implementation (proportion treated with gel, mean(SD); midwifery led: before 71 (38)%, 3 months after 87 (12)%; doctor led: before 63 (43)%, 3 months after 86 (16)%; adjusted mean change in proportion (95%CI); 19.3% (-4.5–43.1), p = 0.11). There was an increase in the proportion of eligible babies treated with oral dextrose gel from before to 3 months after implementation of the guideline (122/153 (80%) v 144/163 (88%), OR (95%CI); 3.42 (1.67–6.98), p<0.001). Implementation of a clinical practice guideline improved uptake of oral dextrose gel. There was no evidence of a difference between midwife and doctor implementation leaders for implementing this guideline for treatment of hypoglycaemic babies. The trial was prospectively registered on the ISRCTN registry on the 20/05/2015 (ISRCTN61154098).
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Reports the outcome of a survey conducted among key informant health professionals in ten hospitals in New Zealand to assess what was currently working using less tight glycaemic targets for women ...with gestational diabetes mellitus (GDM) and their infants, what barriers and enablers were considered likely when introducing tighter glycaemic targets, and whether these perceptions differed by health professional groups. Source: National Library of New Zealand Te Puna Matauranga o Aotearoa, licensed by the Department of Internal Affairs for re-use under the Creative Commons Attribution 3.0 New Zealand Licence.
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Background
Gestational diabetes mellitus (GDM) affects a significant number of women each year. GDM is associated with a wide range of adverse outcomes for women and their babies. Recent ...observational studies have found physical activity during normal pregnancy decreases insulin resistance and therefore might help to decrease the risk of developing GDM.
Objectives
To assess the effects of physical exercise for pregnant women for preventing glucose intolerance or GDM.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (2 April 2012), ClinicalTrials.gov (2 April 2012) and the WOMBAT Perinatal Trials Registry (2 April 2012).
Selection criteria
Randomised and cluster‐randomised trials assessing the effects of exercise for preventing pregnancy glucose intolerance or GDM.
Data collection and analysis
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies.
Main results
We included five trials with a total of 1115 women and their babies (922 women and their babies contributed outcome data). Four of the five included trials had small sample sizes with one large trial that recruited 855 women and babies. All five included trials had a moderate risk of bias. When comparing women receiving additional exercise interventions with those having routine antenatal care, there was no significant difference in GDM incidence (three trials, 826 women, risk ratio (RR) 1.10, 95% confidence interval (CI) 0.66 to 1.84), caesarean section (two trials, 934 women, RR 1.33, 95% CI 0.97 to 1.84) or operative vaginal birth (two trials, 934 women, RR 0.83, 95% CI 0.58 to 1.17). No trial reported the infant primary outcomes prespecified in the review.
None of the five included trials found significant differences in insulin sensitivity. Evidence from one single large trial suggested no significant difference in the incidence of developing pregnancy hyperglycaemia not meeting GDM diagnostic criteria, pre‐eclampsia or admission to neonatal ward between the two study groups. Babies born to women receiving exercise interventions had a non‐significant trend to a lower ponderal index (mean difference (MD) ‐0.08 gram x 100 m3, 95% CI ‐0.18 to 0.02, one trial, 84 infants). No significant differences were seen between the two study groups for the outcomes of birthweight (two trials, 167 infants, MD ‐102.87 grams, 95% CI ‐235.34 to 29.60), macrosomia (two trials, 934 infants, RR 0.91, 95% CI 0.68 to 1.22), or small‐for‐gestational age (one trial, 84 infants, RR 1.05, 95% CI 0.25 to 4.40) or gestational age at birth (two trials, 167 infants, MD ‐0.04 weeks, 95% CI ‐0.37 to 0.29) or Apgar score less than seven at five minutes (two trials, 919 infants, RR 1.00, 95% CI 0.27 to 3.65). None of the trials reported long‐term outcomes for women and their babies. No information was available on health services costs.
Authors' conclusions
There is limited randomised controlled trial evidence available on the effect of exercise during pregnancy for preventing pregnancy glucose intolerance or GDM. Results from three randomised trials with moderate risk of bias suggested no significant difference in GDM incidence between women receiving an additional exercise intervention and routine care.
Based on the limited data currently available, conclusive evidence is not available to guide practice. Larger, well‐designed randomised trials, with standardised behavioural interventions are needed to assess the effects of exercise on preventing GDM and other adverse pregnancy outcomes including large‐for‐gestational age and perinatal mortality. Longer‐term health outcomes for both women and their babies and health service costs should be included. Several such trials are in progress. We identified another seven trials which are ongoing and we will consider these for inclusion in the next update of this review.
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