Effect of partograph use on outcomes for women in spontaneous labour at term and their babies.

BACKGROUND: The partograph (sometimes known as partogram) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partograph is to provide a pictorial overview of labour, and to alert midwives and obstetricians to deviations in maternal or fetal well-being and labour progress. Charts have traditionally contained pre-printed alert and action lines. An alert line, which is based on the slowest 10% of primigravid women's labours, signifies slow 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.This review is an update of a review last published in 2013. OBJECTIVES: The primary objective was to determine the effectiveness and safety of partograph use on perinatal and maternal morbidity and mortality. The secondary objective was to determine which partograph design is most effective for perinatal and maternal morbidity and mortality outcomes. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 August 2017) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised, cluster-randomised, and quasi-randomised controlled trials involving a comparison of partograph use with no partograph, or comparison between different partograph 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 review authors assessed the studies independently. We assessed the evidence using the GRADE approach. MAIN RESULTS: We have included 11 studies, involving 9475 women in this review; three studies assessed partograph use versus no partograph, seven assessed different partograph designs, and one assessed partograph use versus labour scale. Risk of bias varied in all studies. It was infeasible to blind staff or women to the intervention. Two studies did not adequately conceal allocation. Loss to follow-up was low in all studies. We assessed the evidence for partograph use versus no partograph using the GRADE approach; downgrading decisions were due to study design, inconsistency, indirectness, and imprecision of effect estimates.Most trials reported caesarean section rates and Apgar scores less than 7 at five minutes; all other outcomes were not consistently reported (e.g. duration of first stage of labour and maternal experience of childbirth).Partograph versus no partograph (3 trials, 1813 women)It is uncertain whether there is any clear difference between partograph use and no partograph in caesarean section rates (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.40 to 1.46; n = 1813; 3 trials; I² = 87%; very low-quality evidence); oxytocin augmentation (RR 1.02, 95% CI 0.95 to 1.10; n = 1156; 1 trial; moderate-quality evidence); duration of first stage of labour (mean difference (MD) 0.80 hours, 95% CI -0.06 to 1.66; n = 1156; 1 trial; low-quality evidence); or Apgar score less than 7 at five minutes (RR 0.76, 95% CI 0.29 to 2.03; n = 1596; 2 trials; I² = 87%; very low-quality evidence).Partograph with different placement of action lines (4 trials, 5051 women)When compared to a four-hour action line, women in the two-hour action line group were more likely to receive oxytocin augmentation (average RR 2.44, 95% CI 1.36 to 4.35; n = 4749; 4 trials; I² = 96%). There was no clear difference in caesarean section rates (RR 1.06, 95% CI 0.88 to 1.28; n = 4749; 4 trials); duration of first stage of labour (RR 0.81 hours, 95% CI 0.32 to 2.04; n = 948; 1 trial); maternal experience of childbirth (average RR 0.61, 95% CI 0.28 to 1.35; n = 2269; 2 trials; I² = 83%); or Apgar score less than 7 at five minutes (RR 0.93, 95% CI 0.61 to 1.42; n = 4749; 4 trials) between the two- and four-hour action line.The following comparisons only include data from single studies. Fewer women reported negative childbirth experiences in the two-hour action line group compared to the three-hour action line group (RR 0.49, 95% CI 0.27 to 0.90; n = 348; 1 trial). When we compared the three- and four-hour action line groups, the caesarean section rate was higher in the three-hour action line group (RR 1.70, 95% CI 1.07 to 2.70; n = 613; 1 trial). We did not observe any clear differences in any of the other outcomes in these comparisons.Partograph with alert line only versus partograph with alert and action line (1 trial, 694 women)The caesarean section rate was lower in the alert line only group (RR 0.68, 95% CI 0.50 to 0.93). There were no clear differences between groups for oxytocin augmentation, low Apgar score, instrumental vaginal birth and perinatal death.Partograph with latent phase (composite) versus partograph without latent phase (modified) (1 trial, 743 women)The caesarean section and oxytocin augmentation rates were higher in the partograph with a latent phase (RR 2.45, 95% CI 1.72 to 3.50; and RR 2.18, 95% CI 1.67 to 2.83, respectively). There were no clear differences between groups for oxytocin augmentation, and Apgar score less than 7 at five minutes.Partograph with two-hour action line versus partograph with stepped dystocia line (1 trial, 99 women)Fewer women received oxytocin augmentation in the dystocia line group (RR 0.62, 95% CI 0.39 to 0.98). We did not observe any clear differences in any of the other primary outcomes in this comparison.Partograph versus labour scale (1 trial, 122 women)The use of the partograph compared with the labour scale resulted in fewer women receiving oxytocin augmentation (RR 0.32, 95% CI 0.18 to 0.54), but did not produce any clear differences for any of the other primary outcomes. AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot be certain of the effects of routine use of the partograph as part of standard labour management and care, or which design, if any, are most effective. Further trial evidence is required to establish the efficacy of partograph use per se and its optimum design.

Epidural versus non-epidural or no analgesia for pain management in labour.

BACKGROUND: Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain, and is widely used as a form of pain relief in labour. However, there are concerns about unintended adverse effects on the mother and infant. This is an update of an existing Cochrane Review (Epidural versus non-epidural or no analgesia in labour), last published in 2011. OBJECTIVES: To assess the effectiveness and safety of all types of epidural analgesia, including combined-spinal-epidural (CSE) on the mother and the baby, when compared with non-epidural or no pain relief during labour. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (ClinicalTrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (30 April 2017), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials comparing all types of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. We have not included cluster-randomised or quasi-randomised trials in this update. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risks of bias, extracted data and checked them for accuracy. We assessed selected outcomes using the GRADE approach. MAIN RESULTS: Fifty-two trials met the inclusion criteria and we have included data from 40 trials, involving over 11,000 women. Four trials included more than two arms. Thirty-four trials compared epidural with opioids, seven compared epidural with no analgesia, one trial compared epidural with acu-stimulation, one trial compared epidural with inhaled analgesia, and one trial compared epidural with continuous midwifery support and other analgesia. Risks of bias varied throughout the included studies; six out of 40 studies were at high or unclear risk of bias for every bias domain, while most studies were at high or unclear risk of detection bias. Quality of the evidence assessed using GRADE ranged from moderate to low quality.Pain intensity as measured using pain scores was lower in women with epidural analgesia when compared to women who received opioids (standardised mean difference -2.64, 95% confidence interval (CI) -4.56 to -0.73; 1133 women; studies = 5; I2 = 98%; low-quality evidence) and a higher proportion were satisfied with their pain relief, reporting it to be "excellent or very good" (average risk ratio (RR) 1.47, 95% CI 1.03 to 2.08; 1911 women; studies = 7; I2 = 97%; low-quality evidence). There was substantial statistical heterogeneity in both these outcomes. There was a substantial decrease in the need for additional pain relief in women receiving epidural analgesia compared with opioid analgesia (average RR 0.10, 95% CI 0.04 to 0.25; 5099 women; studies = 16; I2 = 73%; Tau2 = 1.89; Chi2 = 52.07 (P < 0.00001)). More women in the epidural group experienced assisted vaginal birth (RR 1.44, 95% CI 1.29 to 1.60; 9948 women; studies = 30; low-quality evidence). A post hoc subgroup analysis of trials conducted after 2005 showed that this effect is negated when trials before 2005 are excluded from this analysis (RR 1.19, 95% CI 0.97 to 1.46). There was no difference between caesarean section rates (RR 1.07, 95% CI 0.96 to 1.18; 10,350 women; studies = 33; moderate-quality evidence), and maternal long-term backache (RR 1.00, 95% CI 0.89 to 1.12; 814 women; studies = 2; moderate-quality evidence). There were also no clear differences between groups for the neonatal outcomes, admission to neonatal intensive care unit (RR 1.03, 95% CI 0.95 to 1.12; 4488 babies; studies = 8; moderate-quality evidence) and Apgar score less than seven at five minutes (RR 0.73, 95% CI 0.52 to 1.02; 8752 babies; studies = 22; low-quality evidence). We downgraded the evidence for study design limitations, inconsistency, imprecision in effect estimates, and possible publication bias.Side effects were reported in both epidural and opioid groups. Women with epidural experienced more hypotension, motor blockade, fever, and urinary retention. They also had longer first and second stages of labour, and were more likely to have oxytocin augmentation than the women in the opioid group. Women receiving epidurals had less risk of respiratory depression requiring oxygen, and were less likely to experience nausea and vomiting than women receiving opioids. Babies born to women in the epidural group were less likely to have received naloxone. There was no clear difference between groups for postnatal depression, headache, itching, shivering, or drowsiness. Maternal morbidity and long-term neonatal outcomes were not reported.Epidural analgesia resulted in less reported pain when compared with placebo or no treatment, and with acu-stimulation. Pain intensity was not reported in the trials that compared epidural with inhaled analgesia, or continuous support. Few trials reported on serious maternal side effects. AUTHORS' CONCLUSIONS: Low-quality evidence shows that epidural analgesia may be more effective in reducing pain during labour and increasing maternal satisfaction with pain relief than non-epidural methods. Although overall there appears to be an increase in assisted vaginal birth when women have epidural analgesia, a post hoc subgroup analysis showed this effect is not seen in recent studies (after 2005), suggesting that modern approaches to epidural analgesia in labour do not affect this outcome. Epidural analgesia had no impact on the risk of caesarean section or long-term backache, and did not appear to have an immediate effect on neonatal status as determined by Apgar scores or in admissions to neonatal intensive care. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia and non-epidural analgesia on women in labour and long-term neonatal outcomes.

Different insulin types and regimens for pregnant women with pre-existing diabetes.

BACKGROUND: Insulin requirements may change during pregnancy, and the optimal treatment for pre-existing diabetes is unclear. There are several insulin regimens (e.g. via syringe, pen) and types of insulin (e.g. fast-acting insulin, human insulin). OBJECTIVES: To assess the effects of different insulin types and different insulin regimens in pregnant women with pre-existing type 1 or type 2 diabetes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 October 2016), ClinicalTrials.gov (17 October 2016), the WHO International Clinical Trials Registry Platform (ICTRP; 17 October 2016), and the reference lists of retrieved studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared different insulin types and regimens in pregnant women with pre-existing diabetes.We had planned to include cluster-RCTs, but none were identified. We excluded quasi-randomised controlled trials and cross-over trials. We included studies published in abstract form and contacted the authors for further details when applicable. Conference abstracts were superseded by full publications. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, conducted data extraction, assessed risk of bias, and checked for accuracy. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: The findings in this review were based on very low-quality evidence, from single, small sample sized trial estimates, with wide confidence intervals (CI), some of which crossed the line of no effect; many of the prespecified outcomes were not reported. Therefore, they should be interpreted with caution. We included five trials that included 554 women and babies (four open-label, multi-centre, two-arm trials; one single centre, four-arm RCT). All five trials were at a high or unclear risk of bias due to lack of blinding, unclear methods of randomisation, and selective reporting of outcomes. Pooling of data from the trials was not possible, as each trial looked at a different comparison.1. One trial (N = 33 women) compared Lispro insulin with regular insulin and provided very low-quality evidence for the outcomes. There were seven episodes of pre-eclampsia in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (risk ratio (RR) 0.68, 95% CI 0.35 to 1.30). There were five caesarean sections in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (RR 0.59, 95% CI 0.25 to 1.39). There were no cases of fetal anomaly in the Lispro group and one in the regular insulin group, with no clear difference between the groups (RR 0.35, 95% CI 0.02 to 8.08). Macrosomia, perinatal deaths, episodes of birth trauma including shoulder dystocia, nerve palsy, and fracture, and the composite outcome measure of neonatal morbidity were not reported.2. One trial (N = 42 women) compared human insulin to animal insulin, and provided very low-quality evidence for the outcomes. There were no cases of macrosomia in the human insulin group and two in the animal insulin group, with no clear difference between the groups (RR 0.22, 95% CI 0.01 to 4.30). Perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy and fracture and the composite outcome measure of neonatal morbidity were not reported.3. One trial (N = 93 women) compared pre-mixed insulin (70 NPH/30 REG) to self-mixed, split-dose insulin and provided very low-quality evidence to support the outcomes. Two cases of macrosomia were reported in the pre-mixed insulin group and four in the self-mixed insulin group, with no clear difference between the two groups (RR 0.49, 95% CI 0.09 to 2.54). There were seven cases of caesarean section (for cephalo-pelvic disproportion) in the pre-mixed insulin group and 12 in the self-mixed insulin group, with no clear difference between groups (RR 0.57, 95% CI 0.25 to 1.32). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome measure of neonatal morbidity were not reported.4. In the same trial (N = 93 women), insulin injected with a Novolin pen was compared to insulin injected with a conventional needle (syringe), which provided very low-quality evidence to support the outcomes. There was one case of macrosomia in the pen group and five in the needle group, with no clear difference between the different insulin regimens (RR 0.21, 95% CI 0.03 to 1.76). There were five deliveries by caesarean section in the pen group compared with 14 in the needle group; women were less likely to deliver via caesarean section when insulin was injected with a pen compared to a conventional needle (RR 0.38, 95% CI 0.15 to 0.97). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture, and the composite outcome measure of neonatal morbidity were not reported.5. One trial (N = 223 women) comparing insulin Aspart with human insulin reported none of the review's primary outcomes: macrosomia, perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia. nerve palsy, or fracture, or the composite outcome measure of neonatal morbidity.6. One trial (N = 162 women) compared insulin Detemir with NPH insulin, and supported the outcomes with very low-quality evidence. There were three cases of major fetal anomalies in the insulin Detemir group and one in the NPH insulin group, with no clear difference between the groups (RR 3.15, 95% CI 0.33 to 29.67). Macrosomia, perinatal death, pre-eclampsia, caesarean section, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome of neonatal morbidity were not reported. AUTHORS' CONCLUSIONS: With limited evidence and no meta-analyses, as each trial looked at a different comparison, no firm conclusions could be made about different insulin types and regimens in pregnant women with pre-existing type 1 or 2 diabetes. Further research is warranted to determine who has an increased risk of adverse pregnancy outcome. This would include larger trials, incorporating adequate randomisation and blinding, and key outcomes that include macrosomia, pregnancy loss, pre-eclampsia, caesarean section, fetal anomalies, and birth trauma.

Epidural versus non-epidural or no analgesia in labour.

BACKGROUND: Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain and is widely used as a form of pain relief in labour. However, there are concerns regarding unintended adverse effects on the mother and infant. OBJECTIVES: To assess the effects of all modalities of epidural analgesia (including combined-spinal-epidural) on the mother and the baby, when compared with non-epidural or no pain relief during labour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2011). SELECTION CRITERIA: Randomised controlled trials comparing all modalities of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. DATA COLLECTION AND ANALYSIS: Two of the review authors independently assessed trials for eligibility, methodological quality and extracted all data. We entered data into RevMan and double checked it for accuracy. Primary analysis was by intention to treat; we conducted subgroup and sensitivity analyses where substantial heterogeneity was evident. MAIN RESULTS: We included 38 studies involving 9658 women; all but five studies compared epidural analgesia with opiates. Epidural analgesia was found to offer better pain relief (mean difference (MD) -3.36, 95% confidence interval (CI) -5.41 to -1.31, three trials, 1166 women); a reduction in the need for additional pain relief (risk ratio (RR) 0.05, 95% CI 0.02 to 0.17, 15 trials, 6019 women); a reduced risk of acidosis (RR 0.80, 95% CI 0.68 to 0.94, seven trials, 3643 women); and a reduced risk of naloxone administration (RR 0.15, 95% CI 0.10 to 0.23, 10 trials, 2645 women). However, epidural analgesia was associated with an increased risk of assisted vaginal birth (RR 1.42, 95% CI 1.28 to 1.57, 23 trials, 7935 women), maternal hypotension (RR 18.23, 95% CI 5.09 to 65.35, eight trials, 2789 women), motor-blockade (RR 31.67, 95% CI 4.33 to 231.51, three trials, 322 women), maternal fever (RR 3.34, 95% CI 2.63 to 4.23, six trials, 2741 women), urinary retention (RR 17.05, 95% CI 4.82 to 60.39, three trials, 283 women), longer second stage of labour (MD 13.66 minutes, 95% CI 6.67 to 20.66, 13 trials, 4233 women), oxytocin administration (RR 1.19, 95% CI 1.03 to 1.39, 13 trials, 5815 women) and an increased risk of caesarean section for fetal distress (RR 1.43, 95% CI 1.03 to 1.97, 11 trials, 4816 women). There was no evidence of a significant difference in the risk of caesarean section overall (RR 1.10, 95% CI 0.97 to 1.25, 27 trials, 8417 women), long-term backache (RR 0.96, 95% CI 0.86 to 1.07, three trials, 1806 women), Apgar score less than seven at five minutes (RR 0.80, 95% CI 0.54 to 1.20, 18 trials, 6898 women), and maternal satisfaction with pain relief (RR 1.31, 95% CI 0.84 to 2.05, seven trials, 2929 women). We found substantial heterogeneity for the following outcomes: pain relief; maternal satisfaction; need for additional means of pain relief; length of second stage of labour; and oxytocin augmentation. This could not be explained by subgroup or sensitivity analyses, where data allowed analysis. No studies reported on rare but potentially serious adverse effects of epidural analgesia. AUTHORS' CONCLUSIONS: Epidural analgesia appears to be effective in reducing pain during labour. However, women who use this form of pain relief are at increased risk of having an instrumental delivery. Epidural analgesia had no statistically significant impact on the risk of caesarean section, maternal satisfaction with pain relief and long-term backache and did not appear to have an immediate effect on neonatal status as determined by Apgar scores. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia on women in labour and long-term neonatal outcomes.

Preconception counselling for women with epilepsy to reduce adverse pregnancy outcome.

BACKGROUND: The provision of preconception counselling to women with epilepsy (WWE) has become established as recommended practice and includes a review of drug treatment and the provision of information and advice on both seizure and treatment-related risks to both mother and child. In this review we assess the evidence regarding the effectiveness of preconception counselling for WWE. OBJECTIVES: To determine the effectiveness of preconception counselling for WWE, measured by a reduction in adverse pregnancy outcome in both mother and child; increased knowledge of preconception issues in WWE and increasing intention to plan pregnancy. SEARCH STRATEGY: We searched the Epilepsy Group's Specialized Register (30/01/2008), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 4), and electronic databases: MEDLINE (OVID) (1950-February 2008); SCOPUS (1966-March 2008); CINAHL (1982-March 2008); PsyclNFO (1806-March 2008); ASSIA (1987-March 2008). SELECTION CRITERIA: Randomised control trials; including cluster and quasi-randomised trials, prospective cohorts, controlled before and after studies, and interrupted time series that compared the outcomes in mothers with epilepsy and infants of mothers with epilepsy who received preconception counselling, to the outcomes of mothers with epilepsy and their infants who received standard care or no intervention. DATA COLLECTION AND ANALYSIS: The methodological quality of potentially relevant studies were assessed to determine appropriate inclusion. Where necessary, study authors were contacted for additional information. No studies met the review inclusion criteria. MAIN RESULTS: The search strategy identified 11 studies for consideration of inclusion. However, none met the required criteria for inclusion. AUTHORS' CONCLUSIONS: There is no evidence to inform the content, methods of delivery or effectiveness of preconception counselling to improve pregnancy outcomes for WWE and their offspring. The value of counselling delivered to WWE prior to conception, with the intention of reducing the risks of adverse outcome in mother and child, requires evaluation in well-designed studies, appropriately powered to detect changes in both maternal and infant outcome.