Restrictive versus routine episiotomy among Southeast Asian term pregnancies: a multicentre randomised controlled trial.

OBJECTIVE: To determine whether restrictive or routine episiotomy in term pregnant Southeast Asian women results in fewer complications. DESIGN: A multicentre randomised controlled trial. SETTING: Two tertiary and two general hospitals in Thailand. POPULATION: 3006 singleton pregnant women 18 years or older, ≥37 weeks of gestation, cephalic presentation and planned vaginal delivery. METHODS: This randomised controlled trial compared routine versus restrictive episiotomies in Thai women giving birth vaginally. Participants were singleton, term pregnant women with cephalic presentation. Block randomisation was stratified by study site and parity. Risk ratios (RR) and 95% confidence intervals (CI) were calculated to indicate between-group differences. MAIN OUTCOME MEASURES: Primary outcome was severe perineal laceration. Secondary outcomes included vaginal laceration, cervical laceration, and pregnancy outcomes. RESULTS: 3006 women were randomly assigned to restrictive (1502) and routine (1504) episiotomy. There was no difference in severe perineal laceration between the groups (RR 0.72, 95% CI 0.46-1.12). Restrictive episiotomy resulted in more intact perineums in multiparous women (RR 3.09, 95% CI 2.10-4.56). Restrictive episiotomy increased the risk of vaginal laceration in primiparous (RR 1.96, 95% CI 1.62-2.37) and multiparous women (RR 2.21, 95% CI 1.77-2.75) but did not lead to more suturing. There were comparable risks of cervical laceration, postpartum haemorrhage, wound complication, birth asphyxia, and admission to neonatal intensive care unit. CONCLUSIONS: Restrictive episiotomy results in more intact perineum in multiparous women. Risks of maternal and neonatal outcomes were comparable between the two practices. These results strengthen the certainty of the existing Cochrane review findings in supporting restrictive episiotomy. TWEETABLE ABSTRACT: Restrictive episiotomy results in more intact perineums after vaginal birth in multiparous Southeast Asian women.

Maternal characteristics and causes associated with refractory postpartum haemorrhage after vaginal birth: a secondary analysis of the WHO CHAMPION trial data.

OBJECTIVE: To assess the maternal characteristics and causes associated with refractory postpartum haemorrhage (PPH). DESIGN: Secondary analysis of the WHO CHAMPION trial data. SETTING: Twenty-three hospitals in ten countries. POPULATION: Women from the CHAMPION trial who received uterotonics as first-line treatment of PPH. METHODS: We assessed the association between sociodemographic, pregnancy and childbirth factors and refractory PPH, and compared the causes of PPH between women with refractory PPH and women responsive to first-line PPH treatment. MAIN OUTCOME MEASURES: Maternal characteristics; causes of PPH. RESULTS: Women with labour induced or augmented with uterotonics (adjusted odds ratio [aOR] 1.35; 95% CI 1.07-1.72), with episiotomy or tears requiring suturing (aOR 1.82; 95% CI 1.34-2.48) and who had babies with birthweights ≥3500 g (aOR 1.33; 95% CI 1.04-1.69) showed significantly higher odds of refractory PPH compared with the reference categories in the multivariate analysis adjusted by centre and trial arm. While atony was the sole PPH cause in 53.2% (116/218) of the women in the responsive PPH group, it accounted for only 31.5% (45/143) of the causes in the refractory PPH group. Conversely, tears were the sole cause in 12.8% (28/218) and 28% (40/143) of the responsive PPH and refractory PPH groups, respectively. Placental problems were the sole cause in 11 and 5.6% in the responsive and refractory PPH groups, respectively. CONCLUSION: Women with refractory PPH showed a different pattern of maternal characteristics and PPH causes compared with those with first-line treatment responsive PPH. TWEETABLE ABSTRACT: Women with refractory postpartum haemorrhage are different from those with first-line treatment responsive PPH.

Clinical practice patterns on the use of magnesium sulphate for treatment of pre-eclampsia and eclampsia: a multi-country survey.

OBJECTIVE: To characterise the current clinical practice patterns regarding the use of magnesium sulphate (MgSO4 ) for eclampsia prevention and treatment in a multi-country network of health facilities and compare with international recommendations. DESIGN: Cross-sectional survey. SETTING: A total of 147 health facilities in 15 countries across Africa, Latin America and Asia. POPULATION: Heads of obstetric departments or maternity units. METHODS: Anonymous online and paper-based survey conducted in 2015. MAIN OUTCOME MEASURES: Availability and use of MgSO4 ; availability of a formal clinical protocol for MgSO4 administration; and MgSO4 dosing regimens for eclampsia prevention and treatment. RESULTS: Magnesium sulphate and a formal protocol for its administration were reported to be always available in 87.4% and 86.4% of all facilities, respectively. MgSO4 was used for the treatment of mild pre-eclampsia, severe pre-eclampsia and eclampsia in 24.3%, 93.5% and 96.4% of all facilities, respectively. Regarding the treatment of severe pre-eclampsia, 26.4% and 7.0% of all facilities reported using dosing regimens that were consistent with Zuspan and Pritchard regimens, respectively. Across regions, intramuscular maintenance regimens were more commonly used in the African region (45.7%) than in the Latin American (3.0%) and Asian (22.9%) regions, whereas intravenous maintenance regimens were more often used in the Latin American (94.0%) and Asian (60.0%) regions than in the African region (21.7%). Similar patterns were found for the treatment of eclampsia across regions. CONCLUSIONS: The reported clinical use of MgSO4 for eclampsia prevention and treatment varied widely, and was largely inconsistent with current international recommendations. TWEETABLE ABSTRACT: MgSO4 regimens for eclampsia prevention and treatment in many hospitals are inconsistent with international recommendations.

Clinical pharmacokinetic properties of magnesium sulphate in women with pre-eclampsia and eclampsia.

BACKGROUND: The pharmacokinetic basis of magnesium sulphate (MgSO4 ) dosing regimens for eclampsia prophylaxis and treatment is not clearly established. OBJECTIVES: To review available data on clinical pharmacokinetic properties of MgSO4 when used for women with pre-eclampsia and/or eclampsia. SEARCH STRATEGY: MEDLINE, EMBASE, CINAHL, POPLINE, Global Health Library and reference lists of eligible studies. SELECTION CRITERIA: All study types investigating pharmacokinetic properties of MgSO4 in women with pre-eclampsia and/or eclampsia. DATA COLLECTION AND ANALYSIS: Two authors extracted data on basic pharmacokinetic parameters reflecting the different aspects of absorption, bioavailability, distribution and excretion of MgSO4 according to identified dosing regimens. MAIN RESULTS: Twenty-eight studies investigating pharmacokinetic properties of 17 MgSO4 regimens met our inclusion criteria. Most women (91.5%) in the studies had pre-eclampsia. Baseline serum magnesium concentrations were consistently <1 mmol/l across studies. Intravenous loading dose between 4 and 6 g was associated with a doubling of this baseline concentration half an hour after injection. Maintenance infusion of 1 g/hour consistently produced concentrations well below 2 mmol/l, whereas maintenance infusion at 2 g/hour and the Pritchard intramuscular regimen had higher but inconsistent probability of producing concentrations between 2 and 3 mmol/l. Volume of distribution of magnesium varied (13.65-49.00 l) but the plasma clearance was fairly similar (4.28-5.00 l/hour) across populations. CONCLUSION: The profiles of Zuspan and Pritchard regimens indicate that the minimum effective serum magnesium concentration for eclampsia prophylaxis is lower than the generally accepted level. Exposure-response studies to identify effective alternative dosing regimens should target concentrations achievable by these standard regimens. TWEETABLE ABSTRACT: Minimum effective serum magnesium concentration for eclampsia prophylaxis is lower than the generally accepted therapeutic level.

A global reference for caesarean section rates (C-Model): a multicountry cross-sectional study.

OBJECTIVE: To generate a global reference for caesarean section (CS) rates at health facilities. DESIGN: Cross-sectional study. SETTING: Health facilities from 43 countries. POPULATION/SAMPLE: Thirty eight thousand three hundred and twenty-four women giving birth from 22 countries for model building and 10,045,875 women giving birth from 43 countries for model testing. METHODS: We hypothesised that mathematical models could determine the relationship between clinical-obstetric characteristics and CS. These models generated probabilities of CS that could be compared with the observed CS rates. We devised a three-step approach to generate the global benchmark of CS rates at health facilities: creation of a multi-country reference population, building mathematical models, and testing these models. MAIN OUTCOME MEASURES: Area under the ROC curves, diagnostic odds ratio, expected CS rate, observed CS rate. RESULTS: According to the different versions of the model, areas under the ROC curves suggested a good discriminatory capacity of C-Model, with summary estimates ranging from 0.832 to 0.844. The C-Model was able to generate expected CS rates adjusted for the case-mix of the obstetric population. We have also prepared an e-calculator to facilitate use of C-Model (www.who.int/reproductivehealth/publications/maternal_perinatal_health/c-model/en/). CONCLUSIONS: This article describes the development of a global reference for CS rates. Based on maternal characteristics, this tool was able to generate an individualised expected CS rate for health facilities or groups of health facilities. With C-Model, obstetric teams, health system managers, health facilities, health insurance companies, and governments can produce a customised reference CS rate for assessing use (and overuse) of CS. TWEETABLE ABSTRACT: The C-Model provides a customized benchmark for caesarean section rates in health facilities and systems.

Indirect causes of severe adverse maternal outcomes: a secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health.

OBJECTIVE: To assess the proportion of severe maternal outcomes resulting from indirect causes, and to determine pregnancy outcomes of women with indirect causes. DESIGN: Secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health. SETTING: A total of 359 health facilities in 29 countries in Africa, Asia, Latin America, and the Middle East. SAMPLE: A total of 314 623 pregnant women admitted to the participating facilities. METHODS: We identified the percentage of women with severe maternal outcomes arising from indirect causes. We evaluated the risk of severe maternal and perinatal outcomes in women with, versus without, underlying indirect causes, using adjusted odds ratios and 95% confidence intervals, by a multilevel, multivariate logistic regression model, accounting for clustering effects within countries and health facilities. MAIN OUTCOME MEASURES: Severe maternal outcomes and preterm birth, fetal mortality, early neonatal mortality, perinatal mortality, low birthweight, and neonatal intensive care unit admission. RESULTS: Amongst 314 623 included women, 2822 were reported to suffer from severe maternal outcomes, out of which 20.9% (589/2822; 95% CI 20.1-21.6%) were associated with indirect causes. The most common indirect cause was anaemia (50%). Women with underlying indirect causes showed significantly higher risk of obstetric complications (adjusted odds ratio, aOR, 7.0; 95% CI 6.6-7.4), severe maternal outcomes (aOR 27.9; 95% CI 24.7-31.6), and perinatal mortality (aOR 3.8; 95% CI 3.5-4.1). CONCLUSIONS: Indirect causes were responsible for about one-fifth of severe maternal outcomes. Women with underlying indirect causes had significantly increased risks of severe maternal and perinatal outcomes.

Advanced maternal age and pregnancy outcomes: a multicountry assessment.

OBJECTIVE: To assess the association between advanced maternal age (AMA) and adverse pregnancy outcomes. DESIGN: Secondary analysis of the facility-based, cross-sectional data of the WHO Multicountry Survey on Maternal and Newborn Health. SETTINGS: A total of 359 health facilities in 29 countries in Africa, Asia, Latin America, and the Middle East. SAMPLE: A total of 308 149 singleton pregnant women admitted to the participating health facilities. METHODS: We estimated the prevalence of pregnant women with advanced age (35 years or older). We calculated adjusted odds ratios of individual severe maternal and perinatal outcomes in these women, compared with women aged 20-34 years, using a multilevel, multivariate logistic regression model, accounting for clustering effects within countries and health facilities. The confounding factors included facility and individual characteristics, as well as country (classified by maternal mortality ratio level). MAIN OUTCOME MEASURES: Severe maternal adverse outcomes, including maternal near miss (MNM), maternal death (MD), and severe maternal outcome (SMO), and perinatal outcomes, including preterm birth (<37 weeks of gestation), stillbirths, early neonatal mortality, perinatal mortality, low birthweight (<2500 g), and neonatal intensive care unit (NICU) admission. RESULTS: The prevalence of pregnant women with AMA was 12.3% (37 787/308 149). Advanced maternal age significantly increased the risk of maternal adverse outcomes, including MNM, MD, and SMO, as well as the risk of stillbirths and perinatal mortalities. CONCLUSIONS: Advanced maternal age predisposes women to adverse pregnancy outcomes. The findings of this study would facilitate antenatal counselling and management of women in this age category.

Pregnancy and childbirth outcomes among adolescent mothers: a World Health Organization multicountry study.

OBJECTIVE: To investigate the risk of adverse pregnancy outcomes among adolescents in 29 countries. DESIGN: Secondary analysis using facility-based cross-sectional data of the World Health Organization Multicountry Survey on Maternal and Newborn Health. SETTING: Twenty-nine countries in Africa, Latin America, Asia and the Middle East. POPULATION: Women admitted for delivery in 359 health facilities during 2-4 months between 2010 and 2011. METHODS: Multilevel logistic regression models were used to estimate the association between young maternal age and adverse pregnancy outcomes. MAIN OUTCOME MEASURES: Risk of adverse pregnancy outcomes among adolescent mothers. RESULTS: A total of 124 446 mothers aged ≤24 years and their infants were analysed. Compared with mothers aged 20-24 years, adolescent mothers aged 10-19 years had higher risks of eclampsia, puerperal endometritis, systemic infections, low birthweight, preterm delivery and severe neonatal conditions. The increased risk of intra-hospital early neonatal death among infants born to adolescent mothers was reduced and statistically insignificant after adjustment for gestational age and birthweight, in addition to maternal characteristics, mode of delivery and congenital malformation. The coverage of prophylactic uterotonics, prophylactic antibiotics for caesarean section and antenatal corticosteroids for preterm delivery at 26-34 weeks was significantly lower among adolescent mothers. CONCLUSIONS: Adolescent pregnancy was associated with higher risks of adverse pregnancy outcomes. Pregnancy prevention strategies and the improvement of healthcare interventions are crucial to reduce adverse pregnancy outcomes among adolescent women in low- and middle-income countries.

Maternal complications and perinatal mortality: findings of the World Health Organization Multicountry Survey on Maternal and Newborn Health.

OBJECTIVE: We aimed to determine the prevalence and risks of late fetal deaths (LFDs) and early neonatal deaths (ENDs) in women with medical and obstetric complications. DESIGN: Secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health (WHOMCS). SETTING: A total of 359 participating facilities in 29 countries. POPULATION: A total of 308 392 singleton deliveries. METHODS: We reported on perinatal indicators and determined risks of perinatal death in the presence of severe maternal complications (haemorrhagic, infectious, and hypertensive disorders, and other medical conditions). MAIN OUTCOME MEASURES: Fresh and macerated LFDs (defined as stillbirths ≥ 1000 g and/or ≥28 weeks of gestation) and ENDs. RESULTS: The LFD rate was 17.7 per 1000 births; 64.8% were fresh stillbirths. The END rate was 8.4 per 1000 liveborns; 67.1% occurred by day 3 of life. Maternal complications were present in 22.9, 27.7, and 21.2% [corrected] of macerated LFDs, fresh LFDs, and ENDs, respectively. The risks of all three perinatal mortality outcomes were significantly increased with placental abruption, ruptured uterus, systemic infections/sepsis, pre-eclampsia, eclampsia, and severe anaemia. CONCLUSIONS: Preventing intrapartum-related perinatal deaths requires a comprehensive approach to quality intrapartum care, beyond the provision of caesarean section. Early identification and management of women with complications could improve maternal and perinatal outcomes.

Depot medroxyprogesterone acetate and epithelial ovarian cancer: a multicentre case-control study.

OBJECTIVE: To evaluate the effect of depot medroxyprogesterone acetate (DMPA) in protecting against epithelial ovarian cancer (EOC) and to evaluate factors associated with the risk of EOC. DESIGN: A multicentre, case-control study. SETTING: Twelve hospitals located across Thailand. POPULATION: Three hundred and thirty patients with EOC ('cases') and 982 matched controls were recruited from the 12 hospitals. Cases were newly diagnosed patients with EOC, demonstrated pathologically. Controls were age-matched patients admitted to different wards in the same hospital. METHODS: Cases and controls were interviewed by trained interviewers using a standardised pre-tested questionnaire. The factors associated with EOC were evaluated using univariate and multivariate analyses. MAIN OUTCOME MEASURES: The odds ratio (OR) and 95% confidence interval (95% CI) were calculated to assess the relationship between DMPA and EOC. RESULTS: The use of DMPA was found to be associated with a 39% reduction in the risk of EOC with an OR of 0.61 and a 95% CI of 0.44-0.85 (P = 0.002). A significant risk reduction (83%) was observed when the duration of DMPA use was >3 years (OR 0.17; 95% CI 0.07-0.39; P < 0.001). Other factors associated with a reduced risk of EOC were the use of combined oral contraceptive pills and breastfeeding. A factor associated with an increased risk of EOC was a family history of gynaecological cancer. CONCLUSIONS: The results suggest that DMPA may have a protective effect against EOC. If this effect is real, then it represents an important non-contraceptive benefit of DMPA.

Rapid versus stepwise application of negative pressure in vacuum extraction-assisted vaginal delivery: a multicentre randomised controlled non-inferiority trial.

OBJECTIVE: To evaluate whether the application of rapid negative pressure for vacuum-assisted delivery is as effective and safe as the stepwise method. DESIGN: Randomised controlled trial. SETTING: Six centres, including university, secondary and tertiary hospitals, in Thailand. SAMPLE: In total, 662 women were randomised to rapid and stepwise groups, with 331 women in each group. METHODS: Vacuum extraction was performed by applying a metal cup (Malmstrom) connected to an electric pump to the fetal head. The stepwise method consisted of four incremental steps of 0.2 kg/cm² every 2 minutes to obtain a final negative pressure of 0.8 kg/cm². In the rapid method the negative pressure of 0.8 kg/cm² was applied in one step in < 2 minutes. MAIN OUTCOME MEASURES: Success rate of vacuum extraction, vacuum cup detachment rate, duration of vacuum extraction, and maternal and neonatal complications. RESULTS: There were no significant differences in detachment rates (RD 0.3%, 95% CI -3.1 to 2.4). The overall success rates were identical, at 98.2%. There were significant reductions in the time between applying the vacuum cup and attaining maximum negative pressure (MD -4.6 minutes; 95% CI -4.4 to -4.8 minutes), and in the time between applying the cup and delivery (MD -4.4 minutes; 95% CI -4.8 to -4.0 minutes). There was a significantly higher rate of perineal suture in the rapid method group (RD 4.5%; 95% CI 1.1-8.2). There were no significant differences in maternal and fetal morbidities. CONCLUSIONS: Rapid negative pressure vacuum extraction could be performed as effectively and safely as the stepwise method, in a shorter period of time.

Caesarean section without medical indications is associated with an increased risk of adverse short-term maternal outcomes: the 2004-2008 WHO Global Survey on Maternal and Perinatal Health.

BACKGROUND: There is worldwide debate about the appropriateness of caesarean sections performed without medical indications. In this analysis, we aim to further investigate the relationship between caesarean section without medical indication and severe maternal outcomes. METHODS: This is a multicountry, facility-based survey that used a stratified multistage cluster sampling design to obtain a sample of countries and health institutions worldwide. A total of 24 countries and 373 health facilities participated in this study. Data collection took place during 2004 and 2005 in Africa and the Americas and during 2007 and 2008 in Asia. All women giving birth at the facility during the study period were included and had their medical records reviewed before discharge from the hospital. Univariate and multilevel analysis were performed to study the association between each group's mode of delivery and the severe maternal and perinatal outcome. RESULTS: A total of 286,565 deliveries were analysed. The overall caesarean section rate was 25.7% and a total of 1.0 percent of all deliveries were caesarean sections without medical indications, either due to maternal request or in the absence of other recorded indications. Compared to spontaneous vaginal delivery, all other modes of delivery presented an association with the increased risk of death, admission to ICU, blood transfusion and hysterectomy, including antepartum caesarean section without medical indications (Adjusted Odds Ratio (Adj OR), 5.93, 95% Confidence Interval (95% CI), 3.88 to 9.05) and intrapartum caesarean section without medical indications (Adj OR, 14.29, 95% CI, 10.91 to 18.72). In addition, this association is stronger in Africa, compared to Asia and Latin America. CONCLUSIONS: Caesarean sections were associated with an intrinsic risk of increased severe maternal outcomes. We conclude that caesarean sections should be performed when a clear benefit is anticipated, a benefit that might compensate for the higher costs and additional risks associated with this operation.

One-year follow-up of single-visit approach to cervical cancer prevention based on visual inspection with acetic acid wash and immediate cryotherapy in rural Thailand.

The aim is to evaluate 1) the visibility of cervical squamocolumnar junction (SCJ) after cryotherapy treatment and 2) to evaluate the effectiveness of cryotherapy treatment originally performed as part of a safety, acceptability, and feasibility (SAFE) demonstration project evaluating the SAFE of visual inspection with acetic acid (VIA) followed by immediate offer of cryotherapy among those who were tested positive and eligible for treatment. A total of 704 women presented at 1-year follow-up exam during which VIA was performed again by nurses. Six hundred and forty eight (92.0%) women received colposcopy and any kind of biopsy, if indicated, by trained physician colposcopists at a referral hospital. At 1 year, VIA nurses assessed 42 of 648 referred women (6.5%) as abnormal (test positive or suspected cancer). The SCJ was visible to the colposcopists in 91.7% (594/648) of the women. Among 42 women assessed as abnormal by the nurses, colposcopic findings were abnormal in 83.3% (35/42), with one low-grade squamous intraepithelial lesion, two high-grade squamous intraepithelial lesion (HSIL), and one adenocarcinoma confirmed later by biopsy. Among 606 VIA negative women, colposcopy was abnormal in only 23.4% (142/606), with two cases of HSIL confirmed later. Given that the SCJ was visible in the vast majority of women (91.7%) after cryotherapy, VIA could be used to provide follow-up for women previously treated. The disease negative rate after cryotherapy (no human papillomavirus infection, no cervical intraepithelial neoplasia, and no cancer) at 1 year after treatment was 85.5% (554/648).

Long versus short course treatment with Metformin and Clomiphene Citrate for ovulation induction in women with PCOS.

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among reproductive-aged women. Apart from infertility, women with PCOS often have other endocrine disorders, including insulin resistance,hyperinsulinaemia and hyperandrogenism. Metformin,combined with clomiphene citrate (CC), has been shown to be more effective in ovulation induction when compared with clomiphene citrate alone. The optimal duration for metformin pretreatment before initiation of clomiphene citrate, however, is unknown. OBJECTIVES: To determine the effectiveness of short-course (less than four weeks) metformin plus CC versus long-course (four weeks or more) metformin plus CC with regard to ovulation and achievement of pregnancy in infertile PCOS women. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (December 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, 2006 issue 4), MEDLINE (1950 to 7 January 2007), CINAHL (1982 to December 2006) and EMBASE (1980 to 7 January 2007). SELECTION CRITERIA: Randomised controlled trials comparing short-course (less than four weeks) metformin plus CC versus long-course (four weeks or more) metformin plus CC for ovulation or achievement of pregnancy in infertile PCOS women. 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 determine whether short-chouse metformin pretreatment is as effective as the conventional long-course metformin pretreatment before initiation of clomiphene citrate for ovulation induction in infertile PCOS patients. A well-designed randomised controlled trial is needed to answer this important clinical question.

Antibiotics for brain abscesses in people with cyanotic congenital heart disease.

BACKGROUND: Brain abscess is a focal, intracerebral infection that begins as a localized area of brain infection and develops into a collection of pus surrounded by a well-vascularized capsule. People with cyanotic congenital heart disease are at risk of developing brain abscess. OBJECTIVES: To evaluate the effectiveness of antibiotic regimens for treating brain abscess in people with cyanotic congenital heart disease. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library 2006, Issue 2, MEDLINE (January 1966 to June 2006), EMBASE (January 1998 to June 2006), and LILACS (accessed in June 2006). No language or publication restrictions were used. SELECTION CRITERIA: Randomized controlled trials that reported clinically meaningful outcomes and presented results on an intention to treat basis, irrespective of blinding, publication status, or language. DATA COLLECTION AND ANALYSIS: Data were to be extracted, unblinded, by the two reviewers independently. The search identified 489 articles of which 152 were articles on brain abscess. Most of the articles were case series and case reports. MAIN RESULTS: No studies that met the inclusion criteria were identified. AUTHORS' CONCLUSIONS: There are no randomized controlled trials about the effectiveness of antibiotic regimens for treating people with cyanotic congenital heart disease who developed a brain abscess. Currently, the antibiotic regimens used are based on previous retrospective studies and clinical experience. There is a need for a well designed multicentre randomized controlled trial to evaluate the effects of different antibiotic regimens.

Prophylactic antibiotics for transcervical intrauterine procedures.

BACKGROUND: The transcervical intrauterine route is commonly used for operative gynecological procedures in women. The vagina is an area of the body that is abundant with normal bacterial flora. An operative procedure through the vagina may, therefore, be considered to have added potential for resulting in post-procedure infection. Prophylactic antibiotics may play a role in the prevention of post-procedure transcervical intrauterine infections. OBJECTIVES: To assess the effectiveness and safety of antibiotic prophylaxis compared to placebo or no treatment in women undergoing transcervical intrauterine procedures. SEARCH STRATEGY: The search strategy was based on the Menstrual Disorders and Subfertility Group's search strategy. The following databases were searched:Menstrual Disorders and Subfertility Group Specialized Register;Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2006, Issue 4;MEDLINE (1966 to November 2006);EMBASE (1966 to November 2006);Biological Abstracts (1966 to October 2006);AMED (1966 to November 2006). Key words were prepared, in consultation with the Trials Search Coordinator, according to the terms related to our objective: antibiotic, antibiotics, prophylaxis, transvaginal, transcervical intrauterine, endometrial sample, endometrium sampling, endometrial biopsy, hysterosalpingography, hysteroscope, hysteroscopy, hysteroscopic surgery, endometrial ablation, and endometrial resection. SELECTION CRITERIA: The review authors planned to include only truly randomized controlled trials that compared antibiotic prophylaxis with placebo or no treatment in order to prevent infectious complications after transcervical intrauterine procedures. Controlled clinical trials without randomization and pseudo-randomized trial were excluded. DATA COLLECTION AND ANALYSIS: No data collection or analysis was done because no trials were eligible for inclusion in the review. MAIN RESULTS: The search did not identify any randomized controlled trials investigating the effect of antibiotic prophylaxis compared to placebo or no treatment in women undergoing transcervical intrauterine procedures. AUTHORS' CONCLUSIONS: At this time, there are no published randomized controlled trials that assess prophylactic antibiotics effects on infectious complications following transcervical intrauterine procedures. It is, therefore, not possible to draw any conclusions regarding the use of prophylactic antibiotics for the prevention of post-procedure transcervical intrauterine infections.

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.

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.

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.