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P Lumbiganon

Publications and source records attributed to P Lumbiganon.

At least 19 recordsLinked to original sources
PubMed2006

Cluster randomised trial of an active, multifaceted educational intervention based on the WHO Reproductive Health Library to improve obstetric practices.

OBJECTIVE: We conducted a trial to evaluate the effect of an active, multifaceted educational strategy to promote the use of the WHO Reproductive Health Library (RHL) on obstetric practices. DESIGN: Cluster randomised trial. The trial was assigned the International Standardised Randomised Controlled Trial Number ISRCTN14055385. SETTINGS: Twenty-two hospitals in Mexico City and 18 in the Northeast region of Thailand. METHODS: The intervention consisted primarily of three interactive workshops using RHL over a period of 6 months. The focus of the workshops was to provide access to knowledge and enable its use. A computer and support for using both the computer and RHL were provided at each hospital. The control hospitals did not receive any intervention. MAIN OUTCOME MEASURES: The main outcome measures were changes in ten selected clinical practices as recommended in RHL starting approximately four to six months after the third workshop. Clinical practice data were collected at each hospital from 1000 consecutively delivered women or for a 6-month period whichever was reached sooner. RESULTS: The active, multifaceted educational intervention we employed did not affect the ten targeted practices in a consistent and substantive way. Iron/folate supplementation, uterotonic use after birth and breastfeeding on demand were already frequently practiced, and we were unable to measure external cephalic version. Of the remaining six practices, selective, as opposed to routine episiotomy policy increased in the intervention group (difference in adjusted mean rate = 5.3%; 95% CI -0.1 to 10.7%) in Thailand, and there was a trend towards an increased use of antibiotics at caesarean section in Mexico (difference in adjusted mean rate = 19.0%; 95% CI: -8.0 to 46.0%). There were no differences in the use of labour companionship, magnesium sulphate use for eclampsia, corticosteroids for women delivering before 34 weeks and vacuum extraction. RHL awareness (24.8-65.5% in Mexico and 33.9-83.3% in Thailand) and use (4.8-34.9% in Mexico and 15.5-76.4% in Thailand) increased substantially after the intervention in both countries. CONCLUSION: The multifaceted, active strategy to provide health workers with the knowledge and skills to use RHL to improve their practice led to increased access to and use of RHL, however, no consistent or substantive changes in clinical practices were detected within 4-6 months after the third workshop.

Clinical Competence↗
PubMed2006

Prophylactic antibiotics for manual removal of retained placenta in vaginal birth.

BACKGROUND: Retained placenta is a potentially life-threatening condition because of its association with postpartum haemorrhage. Manual removal of placenta increases the likelihood of bacterial contamination in the uterine cavity. OBJECTIVES: To compare the effectiveness and side-effects of routine antibiotic use for manual removal of placenta in vaginal birth in women who received antibiotic prophylaxis and those who did not and to identify the appropriate regimen of antibiotic prophylaxis for this procedure. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 November 2005), CENTRAL (The Cochrane Library, Issue 4, 2005), MEDLINE (from 1966 to January 2005), EMBASE (from 1980 to January 2005), CINAHL (from 1982 to January 2005) and LILACS (from 1982 to January 2005). SELECTION CRITERIA: All randomized controlled trials comparing antibiotic prophylaxis and placebo or non antibiotic use to prevent endometritis after manual removal of placenta in vaginal birth. DATA COLLECTION AND ANALYSIS: If eligible trials were to be identified, trial quality would be assessed and data would be extracted, unblinded by two review authors independently. MAIN RESULTS: No studies that met the inclusion criteria were identified. AUTHORS' CONCLUSIONS: There are no randomized controlled trials to evaluate the effectiveness of antibiotic prophylaxis to prevent endometritis after manual removal of placenta in vaginal birth.

Antibiotic Prophylaxis↗
PubMed2006

Pneumococcal vaccination during pregnancy for preventing infant infection.

BACKGROUND: Each year at least one million children worldwide die of pneumococcal infections. The development of bacterial resistance to antimicrobials adds to the difficulty of treatment of diseases and emphasizes the need for a preventive approach. Newborn vaccination schedules could substantially reduce the impact of pneumococcal disease in immunized children, but does not have an effect on the morbidity and mortality of infants less than three months of age. Pneumococcal vaccination during pregnancy may be a way of preventing pneumococcal disease during the first months of life before the pneumococcal vaccine administered to the infant starts to produce protection. OBJECTIVES: To assess the effect of pneumococcal vaccination during pregnancy for preventing infant infection. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (June 2004), CENTRAL (The Cochrane Library, Issue 2, 2004), MEDLINE (January 1966 to June 2004), EMBASE (January 1985 to June 2004), and reference lists of articles. SELECTION CRITERIA: Randomized controlled trials in pregnant women comparing pneumococcal vaccine with placebo or doing nothing or with another vaccine to prevent infant infections. DATA COLLECTION AND ANALYSIS: Two authors independently assessed methodological quality and extracted data using a data collection form. Study authors were contacted for additional information. MAIN RESULTS: Three trials (280 participants) were included. There was no evidence that pneumococcal vaccination during pregnancy reduces the risk of neonatal infection (one trial, 149 pregnancies, relative risk (RR) 0.51; 95% confidence interval (CI) 0.18 to 1.41). Although the data suggest an effect in reducing pneumococcal colonisation in infants by 16 months of age (one trial, 56 pregnancies, RR 0.33; 95% CI 0.11 to 0.98), there was no evidence of this effect in infants at two months of age (RR 0.28; 95% CI 0.02 to 5.11) or by seven months of age (RR 0.32; 95% CI 0.08 to 1.29). AUTHORS' CONCLUSIONS: There is insufficient evidence to support whether pneumococcal vaccination during pregnancy could reduce infant infections.

Female↗
PubMed2005

Antibiotic prophylaxis for fourth-degree perineal tear during vaginal birth.

BACKGROUND: One to eight per cent of women suffer third-degree perineal tears (anal sphincter injury) and fourth-degree perineal tear (rectal mucosa injury) during vaginal birth, and these tears are more common after forceps delivery (28%) and midline episiotomies. Fourth-degree tears can become contaminated with bacteria from the rectum and this significantly increases in the chance of perineal wound infection. Prophylactic antibiotics might have a role in preventing this infection. OBJECTIVES: To assess the effectiveness of antibiotic prophylaxis for reducing maternal morbidity and side-effects in fourth-degree perineal tear during vaginal birth. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 July 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2005), MEDLINE (1966 to 15 July 2005), and LILACS (1982 to 15 July 2005). SELECTION CRITERIA: Randomised controlled trials which reported data comparing outcomes of prophylactic antibiotics versus placebo or no antibiotics in fourth-degree perineal tear during vaginal birth. DATA COLLECTION AND ANALYSIS: No trials were found that met the selection criteria. MAIN RESULTS: No randomised controlled trials were identified. AUTHORS' CONCLUSIONS: There are insufficient data to support a policy of routine prophylactic antibiotics in fourth-degree perineal tear during vaginal birth. A well-designed randomised controlled trial is needed.

Anal Canal↗
PubMed2005

Prophylactic oral betamimetics for reducing preterm birth in women with a twin pregnancy.

BACKGROUND: Twin pregnancies are associated with a high risk of neonatal mortality and morbidity due to an increased rate of preterm birth. Betamimetics can decrease contraction frequency or delay preterm birth in singleton pregnancies by 24 to 48 hours. The efficacy of oral betamimetics in women with a twin pregnancy is unproven. OBJECTIVES: To assess the effects of prophylactic oral betamimetics administered to women with twin pregnancies. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (May 2004), CENTRAL (The Cochrane Library, Issue 2, 2004), MEDLINE (January 1966 to May 2004), EMBASE (January 1985 to May 2004), and reference lists. SELECTION CRITERIA: Randomized controlled trials in twin pregnancies comparing oral betamimetics with placebo or any intervention with the specific aim of preventing preterm birth. DATA COLLECTION AND ANALYSIS: Standard methods of The Cochrane Collaboration and the Cochrane Pregnancy and Childbirth Group were used. Trials were independently assessed for methodological quality by at least two authors, who extracted data using a data collection form. MAIN RESULTS: Five trials (344 twin pregnancies) were included. All trials compared oral betamimetics to placebo. Betamimetics reduced the incidence of preterm labour (one trial, 50 twin pregnancies, relative risk (RR) 0.40; 95% confidence interval (CI) 0.19 to 0.86). However, betamimetics did not reduce preterm birth less than 37 weeks' gestation (four trials, 276 twin pregnancies, RR 0.85; 95% CI 0.65 to 1.10) or less than 34 weeks' gestation (one trial, 144 twin pregnancies, RR 0.47; 95% CI 0.15 to 1.50). Mean neonatal birthweight in the betamimetic group was significantly higher than in the placebo group (three trials, 478 neonates, weighted mean difference 111.2 grams; 95% CI 22.2 to 200.2). Nevertheless, there was no evidence of an effect of betamimetics in reduction of low birthweight (two trials, 366 neonates, RR 1.19; 95% CI 0.77 to 1.85) or small-for-gestational age neonates (two trials, 178 neonates, RR 0.92; 95% CI 0.52 to 1.65). Two trials (388 neonates) showed that betamimetics significantly reduced the incidence of respiratory distress syndrome but the difference was not significant when the analysis was adjusted for correlation of babies from twins. Three trials (452 neonates) showed no evidence of an effect of betamimetics in reducing neonatal mortality (RR 0.80; 95% CI 0.35 to 1.82). AUTHORS' CONCLUSIONS: There is insufficient evidence to support or refute the use of prophylactic oral betamimetics for preventing preterm birth in women with a twin pregnancy.

Administration, Oral↗
PubMed2004

Vaginal chlorhexidine during labour for preventing maternal and neonatal infections (excluding Group B Streptococcal and HIV).

BACKGROUND: The incidence of chlorioamnionitis occurs in between 8 to 12 women for every 1000 live births and 96% of the cases of chlorioamnionitis are due to ascending infection. Following spontaneous vaginal delivery, 1% to 4% of women develop postpartum endometritis. The incidence of neonatal sepsis is 0.5% to 1% of all infants born. Maternal vaginal bacteria are the main agents for these infections. It is reasonable to speculate that prevention of maternal and neonatal infections might be possible by washing the vagina and cervix with an antibacterial agent for all women during labour. Chlorhexidine belongs to the class of compounds known as the bis-biguanides. Chlorhexidine has antibacterial action against a wide range of aerobic and anaerobic bacteria, including those implicated in peripartal infections. OBJECTIVES: To evaluate the effectiveness and side-effects of chlorhexidine vaginal douching during labour in reducing maternal and neonatal infections (excluding Group B Streptococcal and HIV). SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (July 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2002), MEDLINE (from 1966 to 2002), EMBASE (from 1980 to 2002), CINAHL (from 1982 to 2002) and LILACS (from 1982 to 2002). SELECTION CRITERIA: Randomized or quasi-randomized trials comparing chlorhexidine vaginal douching during labour with placebo or other vaginal disinfectant to prevent (reduce) maternal and neonatal infections (excluding Group B Streptococcal and HIV). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility and quality, extracted and entered the data into the RevMan software and interpreted the data. A third reviewer analysed and interpreted the data. The fourth reviewer also interpreted the data. MAIN RESULTS: Three studies (3012 participants) were included. There was no evidence of an effect of vaginal chlorhexidine during labour in preventing maternal and neonatal infections. Although the data suggest a trend in reducing postpartum endometritis, the difference was not statistically significant (relative risk 0.83; 95% confidence interval 0.61 to 1.13). REVIEWERS' CONCLUSIONS: There is no evidence to support the use of vaginal chlorhexidine during labour in preventing maternal and neonatal infections. There is a need for a well-designed randomized controlled trial using appropriate concentration and volume of vaginal chlorhexidine irrigation solution and with adequate sample size.

Adult↗
PubMed2004

The international infections in pregnancy study: group B streptococcal colonization in pregnant women.

BACKGROUND: Heavy colonization with group B streptococcus (GBS) has been associated with increased risk of preterm birth and neonatal sepsis; the burden of neonatal GBS disease varies geographically. To determine whether variation in heavy colonization and GBS serotypes could contribute to geographic differences in disease burden, we assessed the prevalence of heavy colonization and the distribution of serotypes in asymptomatic pregnant women in multiple countries. METHODS: Cervical, lower vaginal and urine samples were collected from women attending seven prenatal clinics in six countries. Light colonization was defined as GBS isolation from Lim broth only; heavy colonization was isolation from urine or sheep blood agar plates. Isolates were serotyped using capillary precipitation. RESULTS: GBS was present in 11.3% of 1308 participants (range 7.1-21.7%); 5.0% were heavily colonized (0.4-18.8%) and 6.4% were lightly colonized (2.9-8.0%). Serotypes III and V were most common (both 17.2%). Serotypes VII and VIII were found in one study center. CONCLUSIONS: The prevalence of heavy colonization and GBS serotypes varied significantly among our study centers. Whether this variation could in part explain geographic differences in neonatal morbidity and mortality is a hypothesis that needs further study.

Adult↗
PubMed2003

Birthweight-specific neonatal mortality in developing countries and obstetric practices.

OBJECTIVES: To evaluate birthweight-specific neonatal mortality and perinatal interventions in major medical centers in developed and developing countries. METHODS: A survey was developed and electronically mailed to 13 medical centers participating in the Global Network for Perinatal and Reproductive Health (GNPRH). The ability of a center to provide requested data was assessed. The mortality rates and use of specific perinatal interventions in centers in developing countries were compared with developed countries. RESULTS: Nine centers in developing countries responded to the survey, and three centers in developed countries were used for comparison. Data collection was highly variable. Most developing country centers were able to provide data by birthweight but not by gestational age. The differences in mortality rates between developing and developed countries were more pronounced at lower gestational ages and birthweights. A difference was found in perinatal interventions between developing and developed countries. In the former, viability was generally considered 28 weeks, and the gestational age at which cesarean sections were usually performed for the sake of the fetus at preterm gestations varied from 26 to 37 weeks. Most centers did not routinely induce for pPROM; only five out of nine centers used antibiotics to prolong latency. Most centers used tocolysis beginning at 26-28 weeks through 32-37 weeks, and a variety of tocolytic agents were used. Most centers routinely used corticosteroids for preterm infants, and all centers employed repeat weekly steroid dosing if undelivered. CONCLUSIONS: Despite the fact that the GNPRH centers included in this study represent some of the best health care available in these countries, they lag far behind centers in developed countries in neonatal mortality rates and their use of various obstetric practices. Furthermore, incomplete and inconsistent data collection complicates the evaluation of the factors contributing to high neonatal mortality rates.

Birth Weight↗
PubMed2002

Prophylactic antibiotic administration in pregnancy to prevent infectious morbidity and mortality.

BACKGROUND: Some previous studies suggested that prophylactic antibiotics given during pregnancy improved maternal and perinatal outcomes, some did not show any benefit and some even reported adverse effects. OBJECTIVES: To determine the effect of prophylactic antibiotics during second and third trimester of pregnancy on maternal and perinatal outcomes. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register (April 2002), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002) and reference lists of articles were searched. SELECTION CRITERIA: Randomized controlled trials comparing prophylactic antibiotic treatment with placebo or no treatment for women in the second or third trimester of pregnancy before labour. DATA COLLECTION AND ANALYSIS: Trial quality assessment and data extraction were done by the reviewers. MAIN RESULTS: There were six randomized controlled trials which recruited 2184 women to detect the effect of prophylactic antibiotic administration in the second or third trimester on pregnancy outcomes. Antibiotic prophylaxis in unselected pregnant women reduced the risk of prelabour rupture of membranes (Peto odds ratio (OR) 0.32, 95% confidence interval (CI) 0.14 to 0.73). In women with a previous preterm birth there was a risk reduction in low birth weight (OR 0.48, 95% CI 0.27 to 0.84) and postpartum endometritis (OR 0.46, 95% CI 0.24 to 0.89). There was a risk reduction in preterm delivery (OR 0.48, 95% CI 0.28 to 0.81) in pregnant women with a previous preterm birth associated with bacterial vaginosis (BV) during the current pregnancy but there was no risk reduction in pregnant women with previous preterm birth without BV during pregnancy (OR 1.06, 95% CI 0.68 to 1.64). However, vaginal antibiotic prophylaxis during pregnancy did not prevent infectious pregnancy outcomes and there is a possibility of adverse effects such as neonatal sepsis (OR 8.07, 95% CI 1.36 to 47.77). REVIEWER'S CONCLUSIONS: Antibiotic prophylaxis given during the second or third trimester of pregnancy reduces the risk of prelabour rupture of the membranes when given routinely to pregnant women. Beneficial effects on birth weight and the risk of postpartum endometritis were seen for high risk women.

Antibiotic Prophylaxis↗
PubMed2002

Placebo-controlled, double-blind, randomized study of prophylactic antibiotics in elective abdominal hysterectomy.

To assess the efficacy of a single dose of ampicillin or cefazolin in preventing fever and infection after elective abdominal hysterectomy, we conducted a multicentre, randomized, double-blind, controlled trial at Srinagarind Hospital, Faculty of Medicine, Khon Kaen University and Khon Kaen Regional Hospital. Three hundred and thirty patients scheduled for elective abdominal hysterectomy were randomly allocated into either placebo, ampicillin or cefazolin groups. Patients received sterile water (3 mL) or ampicillin (1 g) or cefazolin (1 g) intravenously according to random assignment 30 min before the operation. After the operation, all patients were assessed by blinded independent evaluators until discharged from the hospitals. Our main outcome measures were postoperative fever and infectious morbidity. We found that 321 patients (97.3% of recruited patients) were available for data analysis, 108 in placebo, 106 in ampicillin and 107 in cefazolin group. Febrile morbidity occurred in 13/108 (12.0%), 14/106 (13.2%) and 12/107 (11.2%) of patients in the placebo, ampicillin and cefazolin groups, respectively. There was no statistically significant difference in febrile morbidity between the three groups. Infectious morbidity was found in 29/108 (26.9%), 24/106 (22.6%) and 11/107 (10.3%) of patients in the placebo, ampicillin and cefazolin groups, respectively. There was a statistically significant difference between the placebo and cefazolin groups (P = 0.002). Between the placebo and ampicillin groups, the result was not significantly different (P = 0.476). There was a statistically significant difference between the cefazolin and ampicillin groups (P = 0.015). The common causes of infectious morbidity were urinary tract infection, vaginal cuff infection and surgical wound infection. We concluded that antibiotic prophylaxis by cefazolin should be recommended for elective total abdominal hysterectomy.

Adult↗
PubMed2002

The epidemiology of syphilis in pregnancy.

This study evaluated the magnitude, risk factors and outcomes of syphilis in pregnancy in a large cohort of women in four countries participating in the World Health Organization (WHO) antenatal care trial. All women attending the first prenatal care at each selected clinic were enrolled. Screening at the first antenatal visit was routinely performed with either rapid plasma reagin or Venereal Disease Research Laboratory and confirmed by fluorescent treponemal antibody absorption. All women also had the same syphilis tests after delivery. The initial prevalence, the incidence during pregnancy and the overall prevalence of syphilis at delivery were 0.9%, 0.4% and 1.3% respectively. Risk factors for syphilis during pregnancy were younger age for the incidence and older age and a history of stillbirth for the prevalence. Women with syphilis during pregnancy had significantly more adverse outcomes. We support the recommendation that in addition to the initial testing, a second routine test for syphilis ought to be established early in the third trimester even in low prevalence areas.

Adult↗
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

An international survey of practice variation in the use of antibiotic prophylaxis in cesarean section.

OBJECTIVE: To examine the use of antibiotic prophylaxis in cesarean section in different countries and in relation to a reference regimen. METHOD: Fifty consecutive cesarean sections performed in eight centers in five countries were surveyed. Data from each center were compared to a regimen recommended by the Cochrane Collaboration (one dose of ampicillin or cefazolin administered to all women shortly before the procedure or immediately after cord clamping) using logistic regression with adjustment for procedure type. RESULT: Prophylaxis was used widely, but only four centers administered prophylaxis to all women. Ampicillin and cefazolin were the principal antibiotics used, but broad-spectrum agents and multidrug regimens were also used commonly. Only two centers reliably administered the antibiotic at the appropriate time. The majority of women received only one dose of antibiotic in only three centers. CONCLUSION: The use of antibiotic prophylaxis in cesarean section was variable and often at odds with published recommendations.

Antibiotic Prophylaxis↗
PubMed2001

Bone mineral density of lumbar spines and proximal femur in the normal northeastern Thai women.

OBJECTIVE: To determine reference data for age-matched bone mineral density (BMD) of normal northeastern Thai women. MATERIAL AND METHOD: 350 northeastern Thai women aged 20-70 years were prospectively studied. After interview, the subjects were examined for BMD of lumbar spines and proximal femur. Mean BMD of each group was determined for each skeletal site. Standard deviation (SD) of BMD in the peak group was calculated to determine BMD cutoff level for diagnosing osteoporosis. RESULT: Peak average BMD of lumbar spines was at 40-45 years, whereas peak BMD of proximal femur was at 35-40 years. Mean value of peak BMD of lumbar spines and proximal femur was 1.226 and 1.035 g/cm2, respectively. According to T-score less than -2.5 SD criteria, osteoporosis of lumbar spines and proximal femur was considered when measured BMD was below 0.889 and 0.785 g/cm2, respectively. CONCLUSION: Our study provided the BMD reference data for northeastern Thai women.

Absorptiometry, Photon↗