http://hdl.handle.net/2440/5875 2013-05-19T09:17:30Z http://hdl.handle.net/2440/77522 Title: Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subferfility Author: Tang, Thomas; Lord, Jonathan M.; Norman, Robert John; Yasmin, Ephia; Balen, Adam H. Abstract: BACKGROUND Polycystic ovary syndrome (PCOS) is characterised by infrequent or absent ovulation (anovulation), high levels of male hormones (hyperandrogenaemia) and high levels of insulin (hyperinsulinaemia secondary to increased insulin resistance). Hyperinsulinaemia is associated with an increase in cardiovascular risk and the development of diabetes mellitus. Insulin-sensitising agents such as metformin may be effective in treating the features of PCOS, including anovulation. OBJECTIVES To assess the effectiveness of insulin-sensitising drugs in improving reproductive outcomes and metabolic parameters for women with PCOS. SEARCH METHODS We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (October 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 3rd Quarter 2011), CINAHL (October 2011), MEDLINE (January 1966 to October 2011), and EMBASE (January 1985 to October 2011). SELECTION CRITERIA Randomised controlled trials of insulin sensitising drugs compared with either placebo, no treatment, or an ovulation induction agent for women with PCOS, menstrual disturbance and subfertility. DATA COLLECTION AND ANALYSIS Two review authors independently assessed studies for inclusion and trial quality, and extracted data. MAIN RESULTS Forty-four trials (3992 women) were included for analysis, 38 of them using metformin and involving 3495 women. There was no evidence that metformin improved live birth rates, whether it was used alone (pooled OR 1.80, 95% CI 0.52 to 6.16, 3 trials, 115 women) or in combination with clomiphene (pooled OR 1.16, 95% CI 0.85 to 1.56, 7 trials, 907 women). However, clinical pregnancy rates were improved for metformin versus placebo (pooled OR 2.31, 95% CI 1.52 to 3.51, 8 trials, 707 women) and for metformin and clomiphene versus clomiphene alone (pooled OR 1.51, 95% CI 1.17 to 1.96, 11 trials, 1208 women). In the studies that compared metformin and clomiphene alone, there was evidence of an improved live birth rate (pooled OR 0.3, 95% CI 0.17 to 0.52, 2 trials, 500 women) and clinical pregnancy rate (pooled OR 0.34, 95% 0.21 to 0.55, 2 trials, 500 women) in the group of obese women who took clomiphene. Metformin was also associated with a significantly higher incidence of gastrointestinal disturbances than placebo (pooled OR 4.27, 95% CI 2.4 to 7.59, 5 trials, 318 women) but no serious adverse effects were reported. AUTHORS' CONCLUSIONS In agreement with the previous review, metformin was associated with improved clinical pregnancy but there was no evidence that metformin improves live birth rates whether it is used alone or in combination with clomiphene, or when compared with clomiphene. Therefore, the role of metformin in improving reproductive outcomes in women with PCOS appears to be limited. 2011-12-31T13:30:00Z http://hdl.handle.net/2440/77521 Title: Exercise for pregnant women for preventing gestational diabetes mellitus Author: Han, Shanshan; Middleton, Philippa Fairfax; Crowther, Caroline Anne Abstract: 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. 2011-12-31T13:30:00Z http://hdl.handle.net/2440/77520 Title: Hypnosis for pain management during labour and childbirth Author: Madden, Kelly; Middleton, Philippa Fairfax; Cyna, Allan Michael; Matthewson, Mandy; Jones, Leanne Abstract: BACKGROUND This review is one in a series of Cochrane Reviews investigating pain management for childbirth. These reviews all contribute to an overview of systematic reviews of pain management for women in labour, and share a generic protocol. We examined the current evidence regarding the use of hypnosis for pain management during labour and childbirth. This review updates the findings regarding hypnosis from an earlier review of complementary and alternative therapies for pain management in labour into a stand-alone review. OBJECTIVES To examine the effectiveness and safety of hypnosis for pain management during labour and childbirth. SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (11 January 2012) and the reference lists of primary studies and review articles. SELECTION CRITERIA Randomised controlled trials and quasi-randomised controlled trials comparing preparation for labour using hypnosis and/or use of hypnosis during labour, with or without concurrent use of pharmacological or non-pharmacological pain relief methods versus placebo, no treatment or any analgesic drug or technique. DATA COLLECTION AND ANALYSIS Two assessors independently extracted data and assessed trial quality. Where possible we contacted study authors seeking additional information about data and methodology. MAIN RESULTS We included seven trials randomising a total of 1213 women. All but one of the trials were at moderate to high risk of bias. Although six of the seven trials assessed antenatal hypnotherapy, there were considerable differences between these trials in timing and technique. One trial provided hypnotherapy during labour. No significant differences between women in the hypnosis group and those in the control group were found for the primary outcomes: use of pharmacological pain relief (average risk ratio (RR) 0.63, 95% confidence interval (CI) 0.39 to 1.01, six studies, 1032 women), spontaneous vaginal birth (average RR 1.35, 95% CI 0.93 to 1.96, four studies, 472 women) or satisfaction with pain relief (RR 1.06, 95% CI 0.94 to 1.20, one study, 264 women). There was significant statistical heterogeneity in the data for use of pharmacological pain relief and spontaneous vaginal birth. The primary outcome of sense of coping with labour was reported in two studies as showing no beneficial effect (no usable data available for this review). For secondary outcomes, no significant differences were identified between women in the hypnosis group and women in the control group for most outcomes where data were available. For example, there was no significant difference for satisfaction with the childbirth experience (average RR 1.36, 95% CI 0.52 to 3.59, two studies, 370 women), admissions to the neonatal intensive care unit (average RR 0.58, 95% CI 0.12 to 2.89, two studies, 347 women) or breastfeeding at discharge from hospital (RR 1.00, 95% CI 0.97 to 1.03, one study, 304 women). There was some evidence of benefits for women in the hypnosis group compared with the control group for pain intensity, length of labour and maternal hospital stay, although these findings were based on single studies with small numbers of women. Pain intensity was found to be lower for women in the hypnosis group than those in the control group in one trial of 60 women (mean difference (MD) -0.70, 95% CI -1.03 to -0.37). The same study found that the average length of labour from 5 cm dilation to birth (minutes) was significantly shorter for women in the hypnosis group (mean difference -165.20, 95% CI -223.53 to -106.87, one study, 60 women). Another study found that a smaller proportion of women in the hypnosis group stayed in hospital for more than two days after the birth compared with women in the control group (RR 0.11, 95% CI 0.02 to 0.83, one study, 42 women). AUTHORS' CONCLUSIONS There are still only a small number of studies assessing the use of hypnosis for labour and childbirth. Although the intervention shows some promise, further research is needed before recommendations can be made regarding its clinical usefulness for pain management in maternity care. 2011-12-31T13:30:00Z http://hdl.handle.net/2440/77512 Title: Interventions for preventing recurrent urinary tract infection during pregnancy Author: Schneeberger, Caroline; Geerlings, Suzanne E.; Middleton, Philippa Fairfax; Crowther, Caroline Anne Abstract: BACKGROUND Recurrent urinary tract infections (RUTI) are common in women who are pregnant and may cause serious adverse pregnancy outcomes for both mother and child including preterm birth and small-for-gestational-age babies. Interventions used to prevent RUTI in women who are pregnant can be pharmacological (antibiotics) or non-pharmacological (cranberry products, acupuncture, probiotics and behavioural modifications). So far little is known about the best way to prevent RUTI in pregnant women. OBJECTIVES To assess the effects of interventions for preventing recurrent urinary tract infections in pregnant women. The primary maternal outcomes were RUTI before birth (variously defined) and preterm birth (before 37 weeks). The primary infant outcomes were small-for-gestational age and total mortality. SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (8 June 2012) and reference lists of retrieved articles. SELECTION CRITERIA Published, unpublished and ongoing randomised controlled trials (RCTs), quasi-RCTs, clustered-randomised trials and abstracts of any intervention (pharmacological and non-pharmacological) for preventing RUTI during pregnancy (compared with another intervention, placebo or with usual care). DATA COLLECTION AND ANALYSIS Two review authors independently evaluated the one identified trial for inclusion and assessed trial quality. Two review authors extracted data. Data were checked for accuracy. MAIN RESULTS The review included one trial involving 200 women. The trial compared a daily dose of nitrofurantoin and close surveillance (regular clinic visit, urine cultures and antibiotics when a positive culture was found) with close surveillance only. No significant differences were found for the primary outcomes: recurrent pyelonephritis (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.31 to 2.53, one study, 167 women), recurrent urinary tract infection before birth (RR 0.30, 95% CI 0.06 to 1.38; one study 167 women) and preterm birth (before 37 weeks) (RR 1.18, 95% CI 0.42 to 3.35; one study 147 women). The incidence of asymptomatic bacteriuria (ASB) (at least 103 colonies per mL) (secondary outcome), only reported in women with a clinic attendance rate of more than 90% (RR 0.55, 95% CI 0.34 to 0.89; one study, 102 women), was significantly reduced in women who received nitrofurantoin and close surveillance. AUTHORS' CONCLUSIONS A daily dose of nitrofurantoin and close surveillance has not been shown to prevent RUTI compared with close surveillance alone. A significant reduction of ASB was found in women with a high clinic attendance rate and who received nitrofurantoin and close surveillance. There was limited reporting of both primary and secondary outcomes for both women and infants. No conclusions can be drawn regarding the optimal intervention to prevent RUTI in women who are pregnant. Randomised controlled trials comparing different pharmacological and non-pharmacological interventions are necessary to investigate potentially effective interventions to prevent RUTI in women who are pregnant. Description: Extent: 27p. 2011-12-31T13:30:00Z