Identification of factors associated with stillbirth in Zimbabwe - a cross sectional study.

INTRODUCTION: 98% of the 2.6 million stillbirths per annum occur in low and middle income countries. However, understanding of risk factors for stillbirth in these settings is incomplete, hampering efforts to develop effective strategies to prevent deaths. METHODS: A cross-sectional study of eligible women on the postnatal ward at Mpilo Hospital, Zimbabwe was undertaken between 01/08/2018 and 31/03/2019 (n = 1779). Data were collected from birth records for maternal characteristics, obstetric and past medical history, antenatal care and pregnancy outcome. A directed acyclic graph was constructed with multivariable logistic regression performed to fit the corresponding model specification to data comprising singleton pregnancies, excluding neonatal deaths (n = 1734), using multiple imputation for missing data. Where possible, findings were validated against all women with births recorded in the hospital birth register (n = 1847). RESULTS: Risk factors for stillbirth included: previous stillbirth (29/1691 (2%) of livebirths and 39/43 (91%) of stillbirths, adjusted Odds Ratio (aOR) 2628.9, 95% CI 342.8 to 20,163.0), antenatal care (aOR 44.49 no antenatal care vs. > 4 antenatal care visits, 95% CI 6.80 to 291.19), maternal medical complications (aOR 7.33, 95% CI 1.99 to 26.92) and season of birth (Cold season vs. Mild aOR 14.29, 95% CI 3.09 to 66.08; Hot season vs. Mild aOR 3.39, 95% CI 0.86 to 13.27). Women who had recurrent stillbirth had a lower educational and health status (18.2% had no education vs. 10.0%) and were less likely to receive antenatal care (20.5% had no antenatal care vs. 6.6%) than women without recurrent stillbirth. CONCLUSION: The increased risk in women who have a history of stillbirth is a novel finding in Low and Middle Income Countries (LMICs) and is in agreement with findings from High Income Countries (HICs), although the estimated effect size is much greater (OR in HICs ~ 5). Developing antenatal care for this group of women offers an important opportunity for stillbirth prevention.

Interventions for varicose veins and leg oedema in pregnancy.

BACKGROUND: Pregnancy is presumed to be a major contributory factor in the increased incidence of varicose veins in women, which can in turn lead to venous insufficiency and leg oedema. The most common symptom of varicose veins and oedema is the substantial pain experienced, as well as night cramps, numbness, tingling, the legs may feel heavy, achy, and possibly be unsightly. Treatments for varicose veins are usually divided into three main groups: surgery, pharmacological and non-pharmacological treatments. Treatments of leg oedema comprise mostly symptom reduction rather than cure and use of pharmacological and non-pharmacological approaches. OBJECTIVES: To assess any form of intervention used to relieve the symptoms associated with varicose veins and leg oedema in pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials of treatments for varicose veins or leg oedema, or both, 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. MAIN RESULTS: We included seven trials (involving 326 women). The trials were largely unclear for selection bias and high risk for performance and detection bias.Two studies were placebo-controlled trials. The first one compared a phlebotonic (rutoside) with placebo for the reduction in symptoms of varicose veins; the second study evaluated the efficacy of troxerutin in comparison to placebo among 30 pregnant women in their second trimester with symptomatic vulvar varicosities and venous insufficiency in their lower extremities. Data from this study were not in useable format, so were not included in the analysis. Two trials compared either compression stockings with resting in left lateral position or reflexology with rest for 15 minutes for the reduction of leg oedema. One trial compared standing water immersion for 20 minutes with sitting upright in a chair with legs elevated for 20 minutes. Women standing in water were allowed to stand or walk in place. One trial compared 20 minutes of daily foot massage for five consecutive days and usual prenatal care versus usual prenatal care. The final trial compared three treatment groups for treating leg oedema in pregnancy. The first group was assigned to lateral supine bed rest at room temperature, women in the second group were asked to sit in a bathtub of waist-deep water at 32 ± 0.5 C with their legs horizontal and the third group included the women who were randomised to sitting immersed in shoulder-deep water at 32 ± 0.5 C with legs extended downward. We did not include this study in the analysis as outcomes reported in the paper were not pre-specified outcomes of this review.We planned to use GRADE methods to assess outcomes for two different comparisons and assign a quality rating. However, only two out of three outcomes for one comparison were reported and could be assessed. Evidence from one trial (rutoside versus placebo) for the outcomes of reduction in symptoms and incidence of complications associated with varicose veins and oedema was assessed as of moderate quality. Rutoside versus placeboOne trial involving 69 women, reported that rutoside significantly reduced the symptoms associated with varicose veins (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.11 to 3.22; moderate quality evidence). The incidence of complications (deep vein thrombosis) did not differ significantly between the two groups (risk ratio (RR) 0.17, 95% CI 0.01 to 3.49; moderate quality evidence). There were no significant differences in side-effects (RR 1.30, 95% CI 0.23 to 7.28). Women's perception of pain was not reported in this trial. External pneumatic intermittent compression versus restOne trial, involving 35 women, reported no significant difference in lower leg volume when compression stockings were compared against rest (mean difference (MD) -258.80, 95% CI -566.91 to 49.31). Reflexology versus restingAnother trial, involving 55 women, compared reflexology with rest. Reflexology significantly reduced the symptoms associated with oedema (reduction in symptoms: RR 9.09, 95% CI 1.41 to 58.54). The same study showed a trend towards satisfaction and acceptability with the intervention (RR 6.00, 95% CI 0.92 to 39.11). Water immersion versus leg elevationThere was evidence from one trial, involving 32 women, to suggest that water immersion for 20 minutes in a swimming pool reduces leg volume (RR 0.43, 95% CI 0.22 to 0.83). Foot massage versus routine careOne trial, involving 80 women reported no significant difference in lower leg circumference when foot massage was compared against routine care (MD -0.11, 95% CI -1.02 to 0.80).No other primary or secondary outcomes were reported in the trials. AUTHORS' CONCLUSIONS: There is moderate quality evidence to suggest that rutosides appear to help relieve the symptoms of varicose veins in late pregnancy. However, this finding is based on one study (69 women) and there are not enough data presented in the study to assess its safety in pregnancy. Reflexology or water immersion appears to help improve symptoms for women with leg oedema, but again this is based on two small studies (43 and 32 women, respectively).

Fetal movement counting for assessment of fetal wellbeing.

BACKGROUND: Fetal movement counting is a method by which a woman quantifies the movements she feels to assess the condition of her baby. The purpose is to try to reduce perinatal mortality by alerting caregivers when the baby might be compromised. This method may be used routinely, or only in women who are considered at increased risk of complications affecting the baby. Fetal movement counting may allow the clinician to make appropriate interventions in good time to improve outcomes. On the other hand, fetal movement counting may cause unnecessary anxiety to pregnant women, or elicit unnecessary interventions. OBJECTIVES: To assess outcomes of pregnancy where fetal movement counting was done routinely, selectively or was not done at all; and to compare different methods of fetal movement counting. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-RCTs where fetal movement counting was assessed as a method of monitoring fetal wellbeing. DATA COLLECTION AND ANALYSIS: Two review authors assessed studies for eligibility, assessed the methodological quality of included studies and independently extracted data from studies. Where possible the effects of interventions were compared using risk ratios (RR), and presented with 95% confidence intervals (CI). For some outcomes, the quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: Five studies (71,458 women) were included in this review; 68,654 in one cluster-RCT. None of these five trials were assessed as having low risk of bias on all seven risk of bias criteria. All included studies except for one (which included high-risk women as participants) included women with uncomplicated pregnancies.Two studies compared fetal movement counting with standard care, as defined by trial authors. Two included studies compared two types of fetal movement counting; once a day fetal movement counting (Cardiff count-to-10) with more than once a day fetal movement counting methods. One study compared fetal movement counting with hormone assessment.(1) Routine fetal movement counting versus mixed or undefined fetal movement countingNo study reported on the primary outcome 'perinatal death or severe morbidity'. In one large cluster-RCT, there was no difference in mean stillbirth rates per cluster (standard mean difference (SMD) 0.23, 95% CI -0.61 to 1.07; participants = 52 clusters; studies = one, low quality evidence). The other study reported no fetal deaths. There was no difference in caesarean section rate between groups (RR 0.93, 95% CI 0.60 to 1.44; participants = 1076; studies = one,low quality evidence). Maternal anxiety was significantly reduced with routine fetal movement counting (SMD -0.22, 95% CI -0.35 to -0.10; participants = 1013; studies = one, moderate quality evidence). Maternal-fetal attachment was not significantly different (SMD -0.02, 95% CI -0.15 to 0.11; participants = 951; studies = one, low quality evidence). In one study antenatal admission after reporting of decreased fetal movements was increased (RR 2.72, 95% CI 1.34 to 5.52; participants = 123; studies = one). In another there was a trend to more antenatal admissions per cluster in the counting group than in the control group (SMD 0.38, 95% CI -0.17 to 0.93; participants = 52 clusters; studies = one, low quality evidence). Birthweight less than 10th centile was not significantly different between groups (RR 0.98, 95% CI 0.66 to 1.44; participants = 1073; studies = one, low quality evidence). The evidence was of low quality due to imprecise results and because of concerns regarding unclear risk of bias. (2) Formal fetal movement counting (Modified Cardiff method) versus hormone analysisThere was no difference between the groups in the incidence of caesarean section (RR 1.18, 95% CI 0.83 to 1.69; participants = 1191; studies = one). Women in the formal fetal movement counting group had significantly fewer hospital visits than those randomised to hormone analysis (RR 0.26, 95% CI 0.20 to 0.35), whereas there were fewer Apgar scores less than seven at five minutes for women randomised to hormone analysis (RR 1.72, 95% CI 1.01 to 2.93). No other outcomes reported showed statistically significant differences. 'Perinatal death or severe morbidity' was not reported. (3) Formal fetal movement counting once a day (count-to-10) versus formal fetal movement counting method where counting was done more than once a day (after meals)The incidence of caesarean section did not differ between the groups under this comparison (RR 2.33, 95% CI 0.61 to 8.99; participants = 1400; studies = one). Perinatal death or severe morbidity was not reported. Women were more compliant in using the count-to-10 method than they were with other fetal movement counting methods, citing less interruption with daily activities as one of the reasons (non-compliance RR 0.25, 95% CI 0.19 to 0.32).Except for one cluster-RCT, included studies were small and used different comparisons, making it difficult to measure the outcomes using meta-analyses. The nature of the intervention measured also did not allow blinding of participants and clinicians.. AUTHORS' CONCLUSIONS: This review does not provide sufficient evidence to influence practice. In particular, no trials compared fetal movement counting with no fetal movement counting. Only two studies compared routine fetal movements with standard antenatal care, as defined by trial authors. Indirect evidence from a large cluster-RCT suggested that more babies at risk of death were identified in the routine fetal monitoring group, but this did not translate to reduced perinatal mortality. Robust research by means of studies comparing particularly routine fetal movement counting with selective fetal movement counting is needed urgently, as it is a common practice to introduce fetal movement counting only when there is already suspected fetal compromise.

Amniotomy for shortening spontaneous labour.

BACKGROUND: Intentional artificial rupture of the amniotic membranes during labour, sometimes called amniotomy or 'breaking of the waters', is one of the most commonly performed procedures in modern obstetric and midwifery practice. The primary aim of amniotomy is to speed up contractions and, therefore, shorten the length of labour. However, there are concerns regarding unintended adverse effects on the woman and baby. OBJECTIVES: To determine the effectiveness and safety of amniotomy alone for routinely shortening all labours that start spontaneously. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2010). SELECTION CRITERIA: Randomised controlled trials comparing amniotomy alone versus intention to preserve the membranes. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two authors assessed identified studies for inclusion, assessed risk of bias and extracted data. Primary analysis was by intention to treat. MAIN RESULTS: We have included 15 studies in this updated review, involving 5583 women. In the current review, data for women with spontaneous normal labour were pooled with data from one trial (involving 61 women) where women had spontaneous, but prolonged labour.There was no clear statistically significant difference between the amniotomy and control groups in length of the first stage of labour (mean difference (MD) -20.43 minutes, 95% confidence interval (CI) -95.93 to 55.06), caesarean section (risk ratio (RR) 1.27, 95% CI 0.99 to 1.62), maternal satisfaction with childbirth experience (standardised mean difference (SMD) 0.27, 95% CI -0.49 to 1.04) or low Apgar score less than seven at five minutes (RR 0.57, 95% CI 0.31 to 1.06). There was no consistency between papers regarding the timing of amniotomy during labour in terms of cervical dilatation. AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend that amniotomy should be introduced routinely as part of standard labour management and care. We recommend that the evidence presented in this review should be made available to women offered an amniotomy and may be useful as a foundation for discussion and any resulting decisions made between women and their caregivers.

Amniotomy for shortening spontaneous labour.

BACKGROUND: Intentional artificial rupture of the amniotic membranes during labour, sometimes called amniotomy or 'breaking of the waters', is one of the most commonly performed procedures in modern obstetric and midwifery practice. The primary aim of amniotomy is to speed up contractions and, therefore, shorten the length of labour. However, there are concerns regarding unintended adverse effects on the woman and baby. OBJECTIVES: To determine the effectiveness and safety of amniotomy alone for routinely shortening all labours that start spontaneously. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). SELECTION CRITERIA: Randomised controlled trials comparing amniotomy alone versus intention to preserve the membranes. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two review authors assessed identified studies for inclusion, assessed risk of bias and extracted data. Primary analysis was by intention-to-treat. MAIN RESULTS: We have included 15 studies in this updated review, involving 5583 women. Amniotomy alone versus intention to preserve the membranes (no amniotomy) for spontaneous labour There was no clear statistically significant difference between women in the amniotomy and control groups in length of the first stage of labour (mean difference (MD) -20.43 minutes, 95% confidence interval (CI) -95.93 to 55.06), caesarean section (risk ratio (RR) 1.27, 95% CI 0.99 to 1.63), maternal satisfaction with childbirth experience (MD -1.10, 95% CI -7.15 to 4.95) or Apgar score less than seven at five minutes (RR 0.53, 95% CI 0.28 to 1.00). There was no consistency between trials regarding the timing of amniotomy during labour in terms of cervical dilatation. Amniotomy alone versus intention to preserve the membranes (no amniotomy) for spontaneous labours that have become prolonged There was no clear statistically significant difference between women in the amniotomy and control group in caesarean section (RR 0.95, 95% CI 0.15 to 6.08), maternal satisfaction with childbirth experience (MD 22.00, 95% CI 2.74 to 41.26) or Apgar score less than seven at five minutes (RR 2.86, 95% CI 0.12 to 66.11). AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend that amniotomy should be introduced routinely as part of standard labour management and care. We recommend that the evidence presented in this review should be made available to women offered an amniotomy and may be useful as a foundation for discussion and any resulting decisions made between women and their caregivers.

Effect of partogram use on outcomes for women in spontaneous labour at term.

BACKGROUND: The partogram (sometimes known as partograph) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partogram is to provide a pictorial overview of labour, to alert midwives and obstetricians to deviations in maternal or fetal wellbeing and labour progress. Charts often contain pre-printed alert and action lines. An alert line represents the slowest 10% of primigravid women's labour progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour. OBJECTIVES: To determine the effect of use of partogram on perinatal and maternal morbidity and mortality.To determine the effect of partogram design on perinatal and maternal morbidity and mortality. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2013). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of partogram with no partogram, or comparison between different partogram designs. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining authors assessed the studies independently. MAIN RESULTS: We have included six studies involving 7706 women in this review; two studies assessed partogram versus no partogram and the remainder assessed different partogram designs. There was no evidence of any difference between partogram and no partogram in caesarean section (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.24 to 1.70); instrumental vaginal delivery (RR 1.00, 95% CI 0.85 to 1.17) or Apgar score less than seven at five minutes (RR 0.77, 95% CI 0.29 to 2.06) between the groups. When compared to a four-hour action line, women in the two-hour action line group were more likely to require oxytocin augmentation (RR 1.14, 95% CI 1.05 to 1.22). When the three- and four-hour action line groups were compared, caesarean section rate was lowest in the four-hour action line group and this difference was statistically significant (RR 1.70, 95% CI 1.07 to 2.70, n = 613, one trial). When a partogram with a latent phase (composite) and one without (modified) were compared, the caesarean section rate was lower in the partograph without a latent phase (RR 2.45, 95% CI 1.72 to 3.50, n = 743, one trial). AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend routine use of the partogram as part of standard labour management and care. Given the fact that the partogram is currently in widespread use and generally accepted, it appears reasonable, until stronger evidence is available, that partogram use should be locally determined. Further trial evidence is required to establish the efficacy of partogram use.

Fetal vibroacoustic stimulation for facilitation of tests of fetal wellbeing.

BACKGROUND: Acoustic stimulation of the fetus has been suggested to improve the efficiency of antepartum fetal heart rate testing. OBJECTIVES: To assess the advantages and disadvantages of the use of fetal vibroacoustic stimulation in conjunction with tests of fetal wellbeing. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2013). SELECTION CRITERIA: All published and unpublished randomised controlled trials assessing the merits of the use of fetal vibroacoustic stimulation in conjunction with tests of fetal wellbeing. DATA COLLECTION AND ANALYSIS: All review authors independently extracted data and assessed trial quality. Authors of published and unpublished trials were contacted for further information. MAIN RESULTS: Altogether 12 trials with a total of 6822 participants were included. Fetal vibroacoustic stimulation reduced the incidence of non-reactive antenatal cardiotocography test (nine trials; average risk ratio (RR) 0.62, 95% confidence interval (CI) 0.48 to 0.81). Vibroacoustic stimulation compared with mock stimulation evoked significantly more fetal movements when used in conjunction with fetal heart rate testing (one trial, RR 0.23, 95% CI 0.18 to 0.29). AUTHORS' CONCLUSIONS: Vibroacoustic stimulation offers benefits by decreasing the incidence of non-reactive cardiotocography and reducing the testing time. Further randomised trials should be encouraged to determine not only the optimum intensity, frequency, duration and position of the vibroacoustic stimulation, but also to evaluate the efficacy, predictive reliability, safety and perinatal outcome of these stimuli with cardiotocography and other tests of fetal wellbeing.

Telephone support for women during pregnancy and the first six weeks postpartum.

BACKGROUND: Telephone communication is increasingly being accepted as a useful form of support within health care. There is some evidence that telephone support may be of benefit in specific areas of maternity care such as to support breastfeeding and for women at risk of depression. There is a plethora of telephone-based interventions currently being used in maternity care. It is therefore timely to examine which interventions may be of benefit, which are ineffective, and which may be harmful. OBJECTIVES: To assess the effects of telephone support during pregnancy and the first six weeks post birth, compared with routine care, on maternal and infant outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (23 January 2013) and reference lists of all retrieved studies. SELECTION CRITERIA: We included randomised controlled trials, comparing telephone support with routine care or with another supportive intervention aimed at pregnant women and women in the first six weeks post birth. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed studies identified by the search strategy, carried out data extraction and assessed risk of bias. Data were entered by one review author and checked by a second. Where necessary, we contacted trial authors for further information on methods or results. MAIN RESULTS: We have included data from 27 randomised trials involving 12,256 women. All of the trials examined telephone support versus usual care (no additional telephone support). We did not identify any trials comparing different modes of telephone support (for example, text messaging versus one-to-one calls). All but one of the trials were carried out in high-resource settings. The majority of studies examined support provided via telephone conversations between women and health professionals although a small number of trials included telephone support from peers. In two trials women received automated text messages. Many of the interventions aimed to address specific health problems and collected data on behavioural outcomes such as smoking cessation and relapse (seven trials) or breastfeeding continuation (seven trials). Other studies examined support interventions aimed at women at high risk of postnatal depression (two trials) or preterm birth (two trials); the rest of the interventions were designed to offer women more general support and advice.For most of our pre-specified outcomes few studies contributed data, and many of the results described in the review are based on findings from only one or two studies. Overall, results were inconsistent and inconclusive although there was some evidence that telephone support may be a promising intervention. Results suggest that telephone support may increase women's overall satisfaction with their care during pregnancy and the postnatal period, although results for both periods were derived from only two studies. There was no consistent evidence confirming that telephone support reduces maternal anxiety during pregnancy or after the birth of the baby, although results on anxiety outcomes were not easy to interpret as data were collected at different time points using a variety of measurement tools. There was evidence from two trials that women at high risk of depression who received support had lower mean depression scores in the postnatal period, although there was no clear evidence that women who received support were less likely to have a diagnosis of depression. Results from trials offering breastfeeding telephone support were also inconsistent, although the evidence suggests that telephone support may increase the duration of breastfeeding. There was no strong evidence that women receiving telephone support were less likely to be smoking at the end of pregnancy or during the postnatal period.For infant outcomes, such as preterm birth and infant birthweight, overall, there was little evidence. Where evidence was available, there were no clear differences between groups. Results from two trials suggest that babies whose mothers received support may have been less likely to have been admitted to a neonatal intensive care unit (NICU), although it is not easy to understand the mechanisms underpinning this finding. AUTHORS' CONCLUSIONS: Despite some encouraging findings, there is insufficient evidence to recommend routine telephone support for women accessing maternity services, as the evidence from included trials is neither strong nor consistent. Although benefits were found in terms of reduced depression scores, breastfeeding duration and increased overall satisfaction, the current trials do not provide strong enough evidence to warrant investment in resources.

Vibroacoustic stimulation for fetal assessment in labour in the presence of a nonreassuring fetal heart rate trace.

BACKGROUND: Fetal vibroacoustic stimulation (VAS) is a simple, non-invasive technique where a device is placed on the maternal abdomen over the region of the fetal head and sound is emitted at a predetermined level for several seconds. It is hypothesised that the resultant startle reflex in the fetus and subsequent fetal heart rate (FHR) acceleration or transient tachycardia following VAS provide reassurance of fetal well-being. This technique has been proposed as a tool to assess fetal well-being in the presence of a nonreassuring cardiotocographic (CTG) trace during the first and second stages of labour. OBJECTIVES: To evaluate the clinical effectiveness and safety of VAS in the assessment of fetal well-being during labour, compared with mock or no stimulation for women with a singleton pregnancy exhibiting a nonreassuring FHR pattern. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 September 2012) and reference lists of all retrieved articles. We sought unpublished trials and abstracts submitted to major international congresses and contacted expert informants. SELECTION CRITERIA: All published and unpublished randomised trials that compared maternal and fetal/neonatal/infant outcomes when VAS was used to evaluate fetal status in the presence of a nonreassuring CTG trace during labour, compared with mock or no stimulation. DATA COLLECTION AND ANALYSIS: Two review authors independently sought to assess for inclusion all the potential studies we identified as a result of the search strategy. We planned to resolve any disagreement through discussion or, if required, to consult a third person. Where there was uncertainty about a particular study, we attempted to contact study authors for additional information. However, these attempts were unsuccessful. MAIN RESULTS: The search strategies yielded six studies for consideration of inclusion. However, none of these studies fulfilled the requirements for inclusion in this review. AUTHORS' CONCLUSIONS: There are currently no randomised controlled trials that address the safety and efficacy of VAS used to assess fetal well-being in labour in the presence of a nonreassuring CTG trace. Although VAS has been proposed as a simple, non-invasive tool for assessment of fetal well-being, there is insufficient evidence from randomised trials on which to base recommendations for use of VAS in the evaluation of fetal well-being in labour in the presence of a nonreassuring CTG trace.

Effect of partogram use on outcomes for women in spontaneous labour at term.

BACKGROUND: The partogram (sometimes known as partograph) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partogram is to provide a pictorial overview of labour, to alert midwives and obstetricians to deviations in maternal or fetal wellbeing and labour progress. Charts often contain pre-printed alert and action lines. An alert line represents the slowest 10% of primigravid women's labour progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour. OBJECTIVES: To determine the effect of use of partogram on perinatal and maternal morbidity and mortality. To determine the effect of partogram design on perinatal and maternal morbidity and mortality. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2012). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of partogram with no partogram, or comparison between different partogram designs. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining authors assessed the studies independently. MAIN RESULTS: We have included six studies involving 7706 women in this review; two studies assessed partogram versus no partogram and the remainder assessed different partogram designs. There was no evidence of any difference between partogram and no partogram in caesarean section (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.24 to 1.70); instrumental vaginal delivery (RR 1.00, 95% CI 0.85 to 1.17) or Apgar score less than seven at five minutes (RR 0.77, 95% CI 0.29 to 2.06) between the groups. When compared to a four-hour action line, women in the two-hour action line group were more likely to require oxytocin augmentation (RR 1.14, 95% CI 1.05 to 1.22). When the three- and four-hour action line groups were compared, caesarean section rate was lowest in the four-hour action line group and this difference was statistically significant (RR 1.70, 95% CI 1.07 to 2.70, n = 613, one trial). When a partogram with a latent phase (composite) and one without (modified) were compared, the caesarean section rate was lower in the partograph without a latent phase (RR 2.45, 95% CI 1.72 to 3.50, n = 743, one trial). AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend routine use of the partogram as part of standard labour management and care. Given the fact that the partogram is currently in widespread use and generally accepted, it appears reasonable, until stronger evidence is available, that partogram use should be locally determined. Further trial evidence is required to establish the efficacy of partogram use.

Magpie Trial in the UK: methods and additional data for women and children at 2 years following pregnancy complicated by pre-eclampsia.

BACKGROUND: The Magpie Trial, a randomised trial comparing magnesium sulphate with placebo for women with pre-eclampsia. This paper describes methods used for follow up in the UK, and presents additional data collected. METHODS: In the UK 774 women and their 827 children were included; excluded were women discharged without a surviving child and families who opted out. General practitioners were sent a questionnaire when the child was around 18 months old. When the child was two years, or older, questionnaires asking about the health of the women and children were posted to families. A sample of families was offered a home visit, during which the child was assessed using the Bayley Scales of Infant Development. RESULTS: Of the women, 12 were lost to follow up and three died. Of the children, 12 were lost to follow up, 5 were excluded and 19 died. General practitioners returned 688/759 (91%) questionnaires, as did 619/759 (82%) women. Responses were largely comparable. 32 women had serious morbidity potentially related to pre-eclampsia. 30% of children were reported to have been admitted to hospital. There were no clear differences between the randomised groups in the child's behaviour, women's fertility or use of health service resources. CONCLUSION: Data presented here provide further reassurance about the longer term safety of magnesium sulphate when used for women with pre-eclampsia. Postal questionnaires in the UK to assess the longer term health and wellbeing of women and children recruited to trials are feasible, and can achieve a high response rate. Responses from families and general practitioners were comparable

Women's experiences of participating in the Magpie Trial: a postal survey in the United Kingdom.

BACKGROUND: The Magpie Trial compared magnesium sulfate with placebo for women with preeclampsia. The objective of this study was to explore women's views and experiences of participating in the Magpie Trial in the United Kingdom. METHODS: Postal questionnaires were sent to 771 women participants in the Magpie Trial to assess long-term health of UK women and children. The questionnaire included three questions exploring women's experience of participating in the trial: (a) If time suddenly went backward, and you had to do it all over again, would you agree to participate in the Magpie Trial? (b) Please tell us if there was anything about the Magpie Trial that you think could have been done better; and (c) Please tell us if there was anything about the Magpie Trial, or your experience of joining the trial, that you think was particularly good. RESULTS: Overall, 619 of the 771 women who were sent questionnaires returned them. In response to the three questions: (a) 58 percent (356) of women responded "definitely yes," 27 percent (169) "probably yes," 4 percent (23) "probably no," 5 percent (33) "definitely no," and 5 percent (34) "not sure." No clear evidence was shown of a relationship with allocated treatment, although women who responded "probably or definitely no" were more likely to have had side effects from trial treatment. (b) Although 44 percent of women stated that nothing could have been done better, free text suggestions related to content of recruitment information, and its timing, and wanting to know treatment allocation and trial results. c) Women were generally extremely positive about being followed up and receiving trial results. CONCLUSIONS: Women were largely positive about participation in the trial and its follow-up, but still reported ways they believed the study could have been improved, such as more information, given earlier, which also has implications for clinical care.

Effect of partogram use on outcomes for women in spontaneous labour at term.

BACKGROUND: The partogram (sometimes known as partograph) is usually a pre-printed paper form, on which labour observations are recorded. The aim of the partogram is to provide a pictorial overview of labour, to alert midwives and obstetricians to deviations in maternal or fetal wellbeing and labour progress. Charts often contain pre-printed alert and action lines. An alert line represents the slowest 10% of primigravid women's labour progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour. OBJECTIVES: To determine the effect of use of partogram on perinatal and maternal morbidity and mortality.To determine the effect of partogram design on perinatal and maternal morbidity and mortality. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2008) and CENTRAL (The Cochrane Library, Issue 3, 2007). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of partogram with no partogram, or comparison between different partogram designs. DATA COLLECTION AND ANALYSIS: Three authors independently assessed eligibility, quality and extracted data. When one author was also the trial author, the two remaining authors assessed the studies independently. MAIN RESULTS: We have included five studies in this review, involving 6187 women; two studies assessed partogram versus no partogram and the remainder assessed different partogram designs. There was no evidence of any difference between partogram and no partogram in caesarean section (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.24 to 1.70); instrumental vaginal delivery (RR 1.00, 95% CI 0.85 to 1.17) or Apgar score less than seven at five minutes (RR 0.77, 95% CI 0.29 to 2.06) between the groups. When compared to a four-hour action line, women in the two-hour action line group were more likely to require oxytocin augmentation (RR 1.14, 95% CI 1.05 to 1.22). When the three- and four-hour action line were compared, caesarean section rate was lowest in the four-hour action line group and this difference was statistically significant (RR 1.70, 95% CI 1.07 to 2.70, n = 613 , one trial). AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend routine use of the partogram as part of standard labour management and care. We do recommend that the evidence presented should be used as a basis for discussion between clinicians and women. Further trial evidence is required to establish the efficacy of partogram use.

The natural history of conducting and reporting clinical trials: interviews with trialists.

BACKGROUND: To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. METHODS: Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008. RESULTS: A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations. CONCLUSION: Our results confirm that the conduct and reporting of some trials can be inadequate. Interviews with researchers identified aspects of clinical research that can be especially challenging: establishing appropriate and relevant outcome variables to measure, use of and adherence to the study protocol, recruiting of study participants and reporting and publishing the study findings. Our trialists considered the prestige and impact factors of academic journals to be the most important criteria for selecting those to which they would submit manuscripts.

Deciding to join a perinatal randomised controlled trial: experiences and views of pregnant women enroled in the Magpie Trial.

OBJECTIVE: to provide insight into pregnant women's experiences of participating in a large multi-centre randomised trial. DESIGN: qualitative semi-structured interviews. SETTING: six UK maternity units. PARTICIPANTS: women recruited to the Magpie Trial. The Magpie Trial was a trial of prophylactic anticonvulsants for women with severe pre-eclampsia. MEASUREMENTS FINDINGS: a number of major but related themes emerged regarding influences on the women's decision-making: unpredictability of pre-eclampsia; quality of information received; role of others in the decision-making process; perceived personal benefit from trial participation; and perception of voluntariness of joining. KEY CONCLUSIONS: the data presented give valuable insights into the women's views and experiences of decision-making. Research into many of the other elements of care given during pregnancy and childbirth is still needed, and with this need comes the ethical responsibility of researchers to ensure trials are performed in the most scientifically robust ways, which are also acceptable to women. To examine the experiences of those involved in trial participation and their views about doing so is a crucial way of advancing this. The QUOTE Study increases understanding of the experiences of women participating in a randomised controlled trial. IMPLICATIONS FOR PRACTICE: the general implication for practice is that procedures are needed that can improve the design and conduct of randomised trials and therefore ultimately enhance the experience for future women. Recommendations include informed consent should be tailored, recognising individual differences in the desire for information. For instance the time individuals need to make consent decisions varies, as do their desires to consult with family before agreeing.