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Biomedical subjects

G Carroli

Publications and source records attributed to G Carroli.

At least 19 recordsLinked to original sources
PubMed2001

Meta-analyses in systematic reviews of randomized controlled trials in perinatal medicine: comparison of fixed and random effects models.

There is a need for empirical work comparing the random effects model with the fixed effects model in the calculation of a pooled relative risk in the meta-analysis in systematic reviews of randomized controlled trials. Such comparisons are particularly important when trial results are heterogeneous. We considered 84 independent meta-analyses in which each trial included a set of different women/newborns. These meta-analyses were included in systematic reviews published in the Cochrane Library's pregnancy and childbirth module. Twenty-one of these 84 meta-analyses demonstrated statistical heterogeneity at p<0.10. The random effects model estimates showed wider confidence intervals, particularly in those meta-analyses showing heterogeneity in the trial results. The summary relative risk for the random effects model tended to show a larger protective treatment effect than the fixed effects model in the heterogeneous meta-analyses. In this set of meta-analyses, statistical evaluation of publication bias cannot be shown to account for heterogeneity. Our empirical conclusion is that there may be opposing effects if the random effects model is used in the meta-analysis of clinical trials showing heterogeneity in the results: stronger treatment effects reflected in the summary relative risk, but wider confidence intervals about this summary measure.

Chi-Square Distribution↗
PubMed2001

WHO multicentre randomised trial of misoprostol in the management of the third stage of labour.

BACKGROUND: Postpartum haemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labour, including use of a uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin E1 analogue) has been suggested for this purpose because it has strong uterotonic effects, can be given orally, is inexpensive, and does not need refrigeration for storage. We did a multicentre, double-blind, randomised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour. METHODS: In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, we randomly assigned women about to deliver vaginally to receive 600 microg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly, according to routine practice, plus corresponding identical placebos. The medications were administered immediately after delivery as part of the active management of the third stage of labour. The primary outcomes were measured postpartum blood loss of 1000 mL or more, and the use of additional uterotonics without an unacceptable level of side-effects. We chose an upper limit of a 35% increase in the risk of blood loss of 1000 mL or more as the margin of clinical equivalence, which was assessed by the confidence interval of the relative risk. Analysis was by intention to treat. FINDINGS: 9264 women were assigned misoprostol and 9266 oxytocin. 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded. 366 (4%) of women on misoprostol had a measured blood loss of 1000 mL or more, compared with 263 (3%) of those on oxytocin (relative risk 1.39 [95% CI 1.19-1.63], p<0.0001). 1398 (15%) women in the misoprostol group and 1002 (11%) in the oxytocin group required additional uterotonics (1.40 [1.29-1.51], p<0.0001). Misoprostol use was also associated with a significantly higher incidence of shivering (3.48 [3.15-3.84]) and raised body temperature (7.17 [5.67-9.07]) in the first hour after delivery. INTERPRETATION: 10 IU oxytocin (intravenous or intramuscular) is preferable to 600 microg oral misoprostol in the active management of the third stage of labour in hospital settings where active management is the norm.

Adult↗
PubMed2001

WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care.

BACKGROUND: We undertook a multicentre randomised controlled trial that compared the standard model of antenatal care with a new model that emphasises actions known to be effective in improving maternal or neonatal outcomes and has fewer clinic visits. METHODS: Clinics in Argentina, Cuba, Saudi Arabia, and Thailand were randomly allocated to provide either the new model (27 clinics) or the standard model currently in use (26 clinics). All women presenting for antenatal care at these clinics over an average of 18 months were enrolled. Women enrolled in clinics offering the new model were classified on the basis of history of obstetric and clinical conditions. Those who did not require further specific assessment or treatment were offered the basic component of the new model, and those deemed at higher risk received the usual care for their conditions; however, all were included in the new-model group for the analyses, which were by intention to treat. The primary outcomes were low birthweight (<2500 g), pre-eclampsia/eclampsia, severe postpartum anaemia (<90 g/L haemoglobin), and treated urinary-tract infection. There was an assessment of quality of care and an economic evaluation. FINDINGS: Women attending clinics assigned the new model (n=12568) had a median of five visits compared with eight within the standard model (n=11958). More women in the new model than in the standard model were referred to higher levels of care (13.4% vs 7.3%), but rates of hospital admission, diagnosis, and length of stay were similar. The groups had similar rates of low birthweight (new model 7.68% vs standard model 7.14%; stratified rate difference 0.96 [95% CI -0.01 to 1.92]), postpartum anaemia (7.59% vs 8.67%; 0.32), and urinary-tract infection (5.95% vs 7.41%; -0.42 [-1.65 to 0.80]). For pre-eclampsia/eclampsia the rate was slightly higher in the new model (1.69% vs 1.38%; 0.21 [-0.25 to 0.67]). Adjustment by several confounding variables did not modify this pattern. There were negligible differences between groups for several secondary outcomes. Women and providers in both groups were, in general, satisfied with the care received, although some women assigned the new model expressed concern about the timing of visits. There was no cost increase, and in some settings the new model decreased cost. INTERPRETATIONS: Provision of routine antenatal care by the new model seems not to affect maternal and perinatal outcomes. It could be implemented without major resistance from women and providers and may reduce cost.

Adult↗
PubMed2001

WHO systematic review of randomised controlled trials of routine antenatal care.

BACKGROUND: There is a lack of strong evidence on the effectiveness of the content, frequency, and timing of visits in standard antenatal-care programmes. We undertook a systematic review of randomised trials assessing the effectiveness of different models of antenatal care. The main hypothesis was that a model with a lower number of antenatal visits, with or without goal-oriented components, would be as effective as the standard antenatal-care model in terms of clinical outcomes, perceived satisfaction, and costs. METHODS: The interventions compared were the provision of a lower number of antenatal visits (new model) and a standard antenatal-visits programme. The selected outcomes were pre-eclampsia, urinary-tract infection, postpartum anaemia, maternal mortality, low birthweight, and perinatal mortality. We also selected measures of women's satisfaction with care and cost-effectiveness. This review drew on the search strategy developed for the Cochrane Pregnancy and Childbirth Group of the Cochrane Collaboration. FINDINGS: Seven eligible randomised controlled trials were identified. 57418 women participated in these studies: 30799 in the new-model groups (29870 with outcome data) and 26619 in the standard-model groups (25821 with outcome data). There was no clinically differential effect of the reduced number of antenatal visits when the results were pooled for pre-eclampsia (typical odds ratio 0.91 [95% CI 0.66-1.26]), urinary-tract infection (0.93 [0.79-1.10]). postpartum anaemia (1.01), maternal mortality (0.91 [0.55-1.51]), or low birthweight (1.04 [0.93-1.17]). The rates of perinatal mortality were similar, although the rarity of the outcome did not allow formal statistical equivalence to be attained. Some dissatisfaction with care, particularly among women in more developed countries, was observed with the new model. The cost of the new model was equal to or less than that of the standard model. INTERPRETATION: A model with a reduced number of antenatal visits, with or without goal-oriented components, could be introduced into clinical practice without risk to mother or baby, but some degree of dissatisfaction by the mother could be expected. Lower costs can be achieved.

Adult↗
PubMed2001

Methodological considerations on the design and analysis of an equivalence stratified cluster randomization trial.

The World Health Organization and collaborating institutions in four developing countries have conducted a multi-centre randomized controlled trial, in which clinics were allocated at random to two antenatal care (ANC) models. These were the standard 'Western' ANC model and a 'new' ANC model consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. The two models were compared using the equivalence approach. This paper discusses the implications of the equivalence approach in the sample size calculation, analysis and interpretation of results of this cluster randomized trial. It reviews the ethical aspects regarding informed consent, concluding that the Zelen design has a place in cluster randomization trials. It describes the estimation of the intracluster correlation coefficient (ICC) in a stratified cluster randomized trial using two methods and reports estimates of the ICC obtained for many maternal, newborn and perinatal outcomes. Finally, it discusses analytical problems that arose: issues encountered using a composite index, heterogeneity of the intervention effect across sites, the choice of the method of analysis and the importance of efficacy analyses. The choice of the clustered Woolf estimator and the generalized estimating equations (GEE) as the methods of analysis applied is discussed.

Adult↗
PubMed2001

Prophylactic use of oxytocin in the third stage of labour.

BACKGROUND: Many maternal deaths across the world result from complications of the third stage of labour (when the placenta is delivered). OBJECTIVES: To examine the effect of oxytocin given prophylactically in the third stage of labour on maternal and neonatal outcomes. SEARCH STRATEGY: Relevant trials were identified in the Cochrane Collaboration Controlled Trials Register and the Pregnancy and Childbirth Review Group's Specialised Register of Controlled Trials. Date of last search: May 2001. SELECTION CRITERIA: All acceptably randomised or quasi-randomised controlled trials including pregnant women anticipating a vaginal delivery where oxytocin was given prophylactically for the third stage of labour. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for relevance and methodological quality, and extracted data. Analysis was by intention to treat. Subgroup analyses were based on extent of selection bias, oxytocin in the context of active or expectant management of the third stage, and timing of administration. Results are presented as relative risks, and weighted mean difference, both with 95% confidence intervals using a fixed effects model. MAIN RESULTS: In seven trials involving over 3000 women in hospital and/or developed country settings, prophylactic oxytocin showed benefits (reduced blood loss (relative risk (RR) for blood loss > 500 ml 0.50; 95% confidence interval (CI) 0.43, 0.59) and need for therapeutic oxytocics (RR 0.50; 95% CI 0.39, 0.64).) compared to no uterotonics, although there was a non-significant trend towards more manual removal of the placenta (RR 1.17; 95% CI 0.79, 1.73) which was most marked in the expectant management subgroup, and blood transfusions (RR 1.30; 95% CI 0.50, 3.39) in the trials with more manual removals of the placenta). In six trials involving over 2800 women, there was little evidence of differential effects for oxytocin versus ergot alkaloids, except ergot alkaloids are associated with more manual removals of the placenta (RR 0.57; 95% CI 0.41, 0.79), and with the suggestion of more raised blood pressure (RR 0.53; 95% CI 0.19, 1.58) than with oxytocin. In five trials involving over 2800 women, there was little evidence of a synergistic effects of adding oxytocin to ergometrine versus ergometrine alone. For all other outcomes in the comparisons either there are no data or the number of adverse events is very small, and so definite conclusions cannot be drawn. REVIEWER'S CONCLUSIONS: There are strong suggestions of benefit for oxytocin in terms of postpartum haemorrhage, and the need for therapeutic oxytocics, but without sufficient information about other outcomes and side-effects it is difficult to be confident about the trade-offs for these benefits, especially if the risk of manual removal of the placenta may be increased. There seems little evidence in favour of ergot alkaloids alone compared to either oxytocin alone, or to Syntometrine, but the data are sparse. More trials are needed in domiciliary deliveries in developing countries, which shoulder most of the burden of third stage complications.

Ergot Alkaloids↗
PubMed2001

How effective is antenatal care in preventing maternal mortality and serious morbidity? An overview of the evidence.

This is an overview of evidence of the effectiveness of antenatal care in relation to maternal mortality and serious morbidity, focused in particular on developing countries. It concentrates on the major causes of maternal mortality, and traces their antecedent morbidities and risk factors in pregnancy. It also includes interventions aimed at preventing, detecting or treating any stage along this pathway during pregnancy. This is an updated and expanded version of a review first published by the World Health Organization (WHO) in 1992. The scientific evidence from randomised controlled trials and other types of intervention or observational study on the effectiveness of these interventions is reviewed critically. The sources and quality of available data, and possible biases in their collection or interpretation are considered. As in other areas of maternal health, good-quality evidence is scarce and, just as in many aspects of health care generally, there are interventions in current practice that have not been subjected to rigorous evaluation. A table of antenatal interventions of proven effectiveness in conditions that can lead to maternal mortality or serious morbidity is presented. Interventions for which there is some promising evidence, short of proof, of effectiveness are explored, and the outstanding questions formulated. These are presented in a series of tables with suggestions about the types of study needed to answer them.

Evidence-Based Medicine↗
PubMed2001

The gap between evidence and practice in maternal healthcare.

The expected improvement in maternal and perinatal health in developing countries has not yet materialized. In addition to the factors related to socioeconomic conditions, we have identified areas where large gaps between evidence and practice are apparent. These gaps are in clinical care, implementation of effective practices and in selecting research priorities. We present examples from our own research and the literature to illustrate these points.

Clinical Trials as Topic↗
PubMed2000

Perinatal factors associated with blood pressure during childhood.

This study aims to determine whether variables reflecting an adverse intrauterine environment are associated with childhood blood pressure. The authors conducted a secondary analysis of data from a prospective cohort of children born to healthy, nulliparous women enrolled in a randomized controlled trial. A total of 518 children were traced in 1995-1996 from 614 eligible children born in a clinic in Rosario, Argentina. The outcome was systolic blood pressure at 5-9 years. Hemoglobin during pregnancy was positively associated with children's pressure. Other maternal characteristics during pregnancy (blood pressure, smoking, weight gain, weight at 20 weeks' gestation, and glycemia) and size at birth (birth weight, ponderal index, head circumference/length ratio, and small for gestational age) were not associated with children's pressure. Among children in the upper quartile of body mass index, there was a weak inverse correlation between birth weight and systolic pressure, and systolic pressure was 14.8 mmHg (95 percent confidence interval: 3.3, 26.4) higher in low birth weight children than in others. The main predictors of childhood pressure were childhood body mass index and maternal pressure outside pregnancy. In this healthy population, the authors found weak support for an association between variables reflecting an adverse fetal environment and childhood blood pressure. Low birth weight was a risk factor for high blood pressure only in overweight children.

Analysis of Variance↗
PubMed2000

Episiotomy for vaginal birth.

BACKGROUND: Episiotomy is done to prevent severe perineal tears, but its routine use has been questioned. The relative effects of midline compared with midlateral episiotomy are unclear. OBJECTIVES: The objective of this review was to assess the effects of restrictive use of episiotomy compared with routine episiotomy during vaginal birth. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register. SELECTION CRITERIA: Randomised trials comparing restrictive use of episiotomy with routine use of episiotomy; restrictive use of mediolateral episiotomy versus routine mediolateral episiotomy; restrictive use of midline episiotomy versus routine midline episiotomy; and use of midline episiotomy versus mediolateral episiotomy. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. MAIN RESULTS: Six studies were included. In the routine episiotomy group, 72.7% (1752/2409) of women had episiotomies, while the rate in the restrictive episiotomy group was 27.6% (673/2441). Compared with routine use, restrictive episiotomy involved less posterior perineal trauma (relative risk 0. 88, 95% confidence interval 0.84 to 0.92), less suturing (relative risk 0.74, 95% confidence interval 0.71 to 0.77) and fewer healing complications (relative risk 0.69, 95% confidence interval 0.56 to 0.85). Restrictive episiotomy was associated with more anterior perineal trauma (relative risk 1.79, 95% 1.55 to 2.07). There was no difference in severe vaginal or perineal trauma (relative risk 1.11, 95% confidence interval 0.83 to 1.50); dyspareunia (relative risk 1.02, 95% confidence interval 0.90 to 1.16); urinary incontinence (relative risk 0.98, 95% confidence interval 0.79 to 1.20) or several pain measures. Results for restrictive versus routine mediolateral versus midline episiotomy were similar to the overall comparison. REVIEWER'S CONCLUSIONS: Restrictive episiotomy policies appear to have a number of benefits compared to routine episiotomy policies. There is less posterior perineal trauma, less suturing and fewer complications, no difference for most pain measures and severe vaginal or perineal trauma, but there was an increased risk of anterior perineal trauma with restrictive episiotomy.

Episiotomy↗
PubMed2000

Patterns of routine antenatal care for low-risk pregnancy.

BACKGROUND: It has been suggested that reduced antenatal care packages or prenatal care managed by providers other than obstetricians for low risk women can be as effective as standard models of antenatal care. OBJECTIVES: The objective of this review was to assess the effects of antenatal care programmes for low-risk women. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, reference lists of articles and we also contacted researchers in the field. Date of last search: April 1999. SELECTION CRITERIA: Randomised trials comparing programmes of antenatal care with varied frequency and timing of the visits and different types of care providers. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted by two reviewers independently. Study authors were contacted for additional information and they were provided with the final version of the review. MAIN RESULTS: Nine trials involving over 25000 women were included. Six trials evaluated the number of visits and three trials evaluated the type of care provider. Most trials were of acceptable quality. Moderate reduction in the number of visits was not associated with an increase in any of the negative perinatal outcomes reviewed. However, trials from developed countries suggest that women can be less satisfied with the reduced number of visits and feel that their expectations with care are not fulfilled. Antenatal care provided by a midwife/general practitioner was associated with improved perception of care by women. Clinical effectiveness of midwife/general practitioner managed care was similar to that of obstetrician/gynaecologist led shared care. REVIEWER'S CONCLUSIONS: It appears that a moderate reduction in the number of antenatal care visits with an increased emphasis on the content of the visits could be implemented without any increase in adverse biological perinatal outcomes. Women can be less satisfied with reduced visits. While clinical effectiveness seemed similar, women appeared to be slightly more satisfied with midwife/general practitioner managed care compared to obstetrician/gynaecologist led shared care.

Female↗
PubMed1999

[Preterm delivery: detection of risks and preventive treatment].

Every year around the world some 13 million premature children are born. Most of these children are born in developing countries, and they account for the largest share of perinatal morbidity and mortality. This review study analyzed scientifically validated data on interventions to prevent at least some portion of these preterm deliveries and to lessen their impact on neonatal health. The Cochrane and MEDLINE bibliographic databases were consulted. Fifty review pieces and research articles were studied, relating to the following aspects of preterm delivery: risk factors and early detection of the risk of preterm delivery; preventing the risk of preterm delivery; treating preterm delivery once it has begun; and preventing neonatal respiratory distress syndrome. There were few successful approaches to the prediction, prevention, or early detection of the threat of preterm delivery. The only measures that can be recommended for all pregnant women are screening for and treating asymptomatic bacteriuria as a part of prenatal check-ups. Screening for bacterial vaginosis and treating it reduce the incidence of preterm births in pregnant women with a history of premature delivery. In addition, prophylactic cerclage decreases the incidence of premature births in pregnant women who have had more than three preterm births. To treat a delivery that starts early, with or without premature membrane rupture, the interventions that have proved to be effective are administering betamimetics to the parturient woman in order to delay delivery for 48 hours, and using indomethacin for the same purpose, as the second-choice drug. The prenatal administration of corticosteroids to the pregnant woman can induce lung maturation in the fetus and reduce respiratory distress syndrome and ventricular hemorrhage, thus decreasing neonatal mortality. There is a need to continue and support basic and epidemiological research in order to develop new knowledge on the causes and mechanisms of preterm delivery and on preventing the morbidity and mortality that preterm delivery produces.

Female↗
PubMed1998

The practice of antenatal care: comparing four study sites in different parts of the world participating in the WHO Antenatal Care Randomised Controlled Trial.

In the preparation of a randomised controlled trial to evaluate a new programme of antenatal care (ANC) in different parts of the world, we conducted a baseline survey of the ANC procedures in all 53 clinics participating in the trial. There were two components of this survey: (1) description of clinic characteristics and services offered: the staff of each clinic was interviewed and direct observation was made by field supervisors, and (2) the actual use of services by pregnant women attending these clinics: we reviewed a random sample of 2913 clinical histories. The clinical units surveyed were offering most of the activities, screening, laboratory tests and interventions recommended as effective according to the Cochrane Pregnancy and Childbirth Database (PCD), although some of these were not available in some sites. On the other hand, some tests and interventions that are considered not effective according to these criteria are reportedly offered. There was a difference across sites in the availability and offer to low-risk women of vaginal examination, evaluation of pelvic size, dental examination, external version for breech presentation and formal risk score classification, and a notable difference in the type of principal provider of ANC. There was a large variation in the actual use of screening and laboratory tests and interventions that should be offered to all women according to Cochrane PCD criteria: some of these are simply not available in a site; others are available, but only a fraction of women attending the clinics are receiving them. The participating sites all purport to follow the traditional 'Western' schedule for ANC, but in three sites we found that a high percentage of women initiate their ANC after the first trimester, and therefore do not have either the recommended minimum number of visits during pregnancy or the minimum first trimester evaluation. It is concluded that the variability and heterogeneity of ANC services provided in the four study sites are disturbing to the profession and cast doubts on the rationale of routine ANC.

Argentina↗