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G Carroli

Publications and source records attributed to G Carroli.

17 recordsLinked to original sources
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↗
PubMed1998

The WHO antenatal care randomised controlled trial: rationale and study design.

The World Health Organisation and collaborating institutions in developing countries are conducting a multicentre randomised controlled trial to evaluate a new antenatal care (ANC) programme, consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. These activities are distributed, for practical reasons, over four visits during the course of pregnancy and are aimed at achieving predetermined goals. The study is taking place in four countries, Argentina, Cuba, Saudi Arabia and Thailand. Recruitment of study subjects started on 1 May 1996. All 53 ANC clinical units had been enrolled by December 1996. Clinics in each country were randomly allocated (cluster randomisation) to provide either the new programme or the traditional programme currently in use. Approximately 24,000 women presenting for ANC at these clinics over an average period of 18 months will have been recruited. As women attending the control clinics receive the 'best standard treatment' as currently offered in these clinics, individual informed consent is requested only from women attending the intervention clinics. Authorities of the corresponding health districts and all participating clinics have provided written institutional informed consent before randomisation. The primary outcome of the trial in relation to maternal conditions is the rate of a morbidity indicator index, defined as the presence of at least one of the following conditions for which ANC is relevant: (a) pre-eclampsia or eclampsia during pregnancy or within 24 h of delivery; (b) postpartum anaemia (haemoglobin < 90 g/L); or (c) severe urinary tract infection/pyelonephritis, defined as an episode requiring antibiotic treatment and/or hospitalisation. The primary fetal outcome is the rate of low birthweight (< 2500 g). Adverse maternal and fetal outcomes are expected for approximately 10% of the control group. Several maternal and perinatal secondary outcomes are also considered. A comprehensive cost-effectiveness analysis and women's and providers' satisfaction evaluation are performed concurrently with the trial. Health-care programmes should be rigorously evaluated by randomised controlled trials, which are feasible in developing countries and should be conducted before introducing new treatments or health interventions.

Argentina↗
PubMed1998

Methodological considerations in the design of the WHO Antenatal Care Randomised Controlled Trial.

We discuss methodological issues arising in a recent evaluation trial of a new antenatal care programme, as sponsored by the Special Programme of Research, Development and Research Training in Human Reproduction, and WHO's Division of Reproductive Health (Technical Support). The randomisation unit for the trial is the antenatal care clinic, with 53 clinics located in four countries randomly allocated to provide either the new programme or the traditional programme currently in use. Approximately 24,000 women presenting for antenatal care over an average period of 18 months will have been recruited.

Argentina↗
PubMed1998

Intra-umbilical vein injection and retained placenta: evidence from a collaborative large randomised controlled trial. Grupo Argentino de Estudio de Placenta Retenida.

OBJECTIVE: To determine whether intra-umbilical vein injection with saline solution, with or without oxytocin, reduces the need for manual removal of placenta compared with expectant management. DESIGN: Multicenter, randomised controlled trial. SETTING: Eleven hospitals in four cities of Argentina: Buenos Aires, Corrientes, Rosario, and Salta. PARTICIPANTS: Two hundred and ninety-one women showing no evidence of placental separation thirty minutes after vaginal delivery. INTERVENTIONS: Three different management strategies: 1. intra-umbilical vein injection of saline solution plus oxytocin; 2. intra-umbilical vein injection of saline solution alone; and 3. expectant management. MAIN OUTCOME MEASURES: Primary: manual removal of the placenta. Secondary: blood loss after trial entry, haemoglobin level at 24 to 48 hours and at 40 to 45 days after delivery, blood transfusion, curettage, infection, and days of hospital stay. RESULTS: Rates of subsequent manual removal were similar: intra-umbilical vein injection of saline solution plus oxytocin (58%; RR 0.92; 95% CI 0.73-1.15), or saline alone (63%; RR 1.00; 95% CI 0.80-1.24), compared with expectant management (63%). There were also no detectable effects of the active managements on any of the secondary measures of outcome. CONCLUSIONS: Based on evidence available from randomised controlled trials, including this trial, it is unlikely that intra-umbilical injection with or without oxytocin, is clinically useful. We recommend that this intervention should not be used in third stage management of labour.

Female↗
PubMed1997

Factors affecting the comparability of meta-analyses and largest trials results in perinatology.

The objective of this report is to provide a new methodology for evaluating the performance of meta-analysis (MA) in corroborating results of large trials (LT) and to identify factors that could explain lack of similarity in the results. We used two criteria to judge the degree of similarity between a MA and the LT: (a) the ratio of the relative risk of the MA to the relative risk of the LT; and (b) the 95% confidence interval about this ratio. Furthermore, this degree of similarity was cross-tabulated with the presence or not of evidence of selective inclusion of positive studies (e.g., publication bias) as judged from "funnel plots" and statistical indicators. Depending on which of our two criteria was used, we found that between 20% and 53% of the 30 MAs studied have high or very high degree of similarity with the LT. We also found strong evidence that factors influencing asymmetrical funnel plots of MA, such as publication bias, may play an important role in this degree of similarity. There was a sizeable proportion of meta-analyses that did not agree with large trial results. We recommend that funnel plots be used as a tool for identifying which MAs can mislead. However, the statistical indicators at hand are unlikely to be of use in many area of medicine considering the regrettably small number of randomized controlled trials per topic available.

Bias↗
PubMed1996

Is routine use of episiotomy justified?

Episiotomy, one of the most common surgical procedures, was introduced in clinical practice in the eighteenth century without having strong scientific evidence of its benefits. Its use was justified by the prevention of severe perineal tears, better future sexual function, and a reduction of urine and fecal incontinence. With regard to the first assumption, the evidence that is based on five randomized controlled trials shows a 9% reduction in severe perineal tears in the selective use of episiotomy, but this effect fluctuates between a 40% reduction and a 38% increase. In relation to long-term effects, women in whom management includes routine use of episiotomy have shown poorer future sexual function, similar pelvic floor muscle strength, and similar urinary incontinence in comparison with women in whom episiotomy is used in a selective manner. In summary, there is no reliable evidence that routine use of episiotomy has any beneficial effect; on the contrary, there is clear evidence that it may cause harm such as a greater need for surgical repair and a poorer future sexual capability. In view of the available evidence the routine use of episiotomy should be abandoned and episiotomy rates > 30% do not seem justified.

Coitus↗
PubMed1995

Predictive ability of meta-analyses of randomised controlled trials.

Although meta-analysis of randomised clinical trials is increasingly used, the evaluation of its ability to predict the results of large trials is not available. We have calculated the relative risks (and 95% confidence intervals) for thirty meta-analyses of different interventions in perinatal medicine, covering 185 randomised controlled trials, but with the largest trial removed. We then compared those results with the result of the largest trial (total sample size more than 1000) done on that intervention and outcome. Twenty-four meta-analyses correctly predicted the direction of the treatment effect, but only eighteen of the thirty were the same both in direction of treatment effect and in statistical significance as the largest trial. There was moderate agreement, beyond chance, between meta-analysis and largest trial results (kappa statistic 0.46-0.53). A meta-analysis demonstrating a protective effect from an intervention of more than 40% had a 60% probability of correctly predicting results of the same magnitude of the largest trial. Researchers and funding agencies may use meta-analysis before recommending a clinical practice or to summarise results of three controlled trials before deciding on additional studies of promising interventions. However, further evaluation of the meta-analytical method is needed if the qualitative and quantitative results it yields are to be better understood.

Confidence Intervals↗
PubMed1989

Selection of mothers with increased risk of delivering low birthweight newborns at a public maternity hospital in Rosario, Argentina.

A retrospective analysis was made of births occurring over a six-month period at a public maternity hospital in the city of Rosario, Argentina, with a view to planning actions reducing the likelihood of low birthweight deliveries. Fifteen risk factors were assessed. While a history of delivering a low birthweight infant was the leading risk factor for both intrauterine growth retardation and preterm delivery, the other leading risk factors for these two types of low birthweight newborns differed. Many variables relating to socioeconomic and cultural levels that have traditionally been considered risk factors for low birthweight did not display any significant association. Risk calculations for the study population were made using data gathered at the patients' first prenatal checkup. These calculations indicated that mothers with one or more of four leading risk factors (a history of delivering low birthweight newborns, smoking more than two cigarettes a day, weighing less than 46 kg, and being less than 148 cm tall) constituted only 26.6% of the study population but accounted for 51.6% of the low birthweight deliveries. Such screening can provide an effective way of selecting high-risk mothers, and simple analyses of this sort are essential in planning health actions relating to low birthweight deliveries.

Age Factors↗
PubMedDate not supplied

Methodological issues of randomized controlled trials for the evaluation of reproductive health interventions.

Randomized controlled trials proved the most valid basis for comparing alternative treatment modalities. Unfortunately, the quality of many such trials has not been as high as our patients deserve. We offer here methodological and practical insights to key issues related to the design, implementation, and analysis of randomized controlled trials in obstetrics and gynecology, based on our experience in exploring research hypotheses in this field. Specifically, we present randomization as a method for the prevention of confounding; we discuss the process of randomization and the bias that can be introduced to randomized controlled trials by some popular methods of randomization. The strategies for presenting baseline comparisons and evaluating the impact of a treatment or intervention are also reviewed. We hope to contribute to a more rigorous selection of treatments for our clinical and public health armamentarium.

Bias↗
PubMedDate not supplied

Randomized clinical trials in perinatology in Latin America.

Latin America needs means to obtain accurate figures about its health conditions in order to apply its resources to priority areas. In addition, health actions must be carefully evaluated to assess their impact, operation and costs. The randomized clinical trial (RCT) is the only design able to show the effectiveness of interventions of moderate effect. Also, it gives appropriate information about the expected effect of the interventions and implies an expediate implementation of interventions in the same places where the project has been performed. In a review of RCTs performed in Latin America on perinatal medicine it can be concluded that some of the focus of research is irrelevant to the region and there is not an orientation towards the cooperative solution of predominant problems in the area. It is imperative for researchers, in Latin America to initiate joint activities in order to assess which are the research priorities of the area, to focus their research on these priorities and to join their efforts in collaborative studies.

Health Services Needs and Demand↗