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P Brocklehurst

Publications and source records attributed to P Brocklehurst.

At least 19 recordsLinked to original sources
PubMed2006

Economic evaluation of alternative management methods of first-trimester miscarriage based on results from the MIST trial.

OBJECTIVES: To compare the cost-effectiveness of alternative management methods of first-trimester miscarriage. DESIGN: Economic evaluation conducted alongside a large randomised controlled trial (the MIST trial). SETTING: Early pregnancy assessment units of seven participating hospitals in southern England. SAMPLE: A total of 1200 women with a confirmed pregnancy of less than 13 weeks of gestation with a diagnosis of incomplete miscarriage or missed miscarriage. METHODS: Random allocation to expectant management, medical management or surgical management. Collection of health service and broader resource use data, unit costs for each resource item and clinical outcomes. MAIN OUTCOME MEASURES: Costs (pounds, 2001-02 prices) to the health service, social services, women, carers and wider society during the first 8 weeks postrandomisation. Cost-effectiveness estimates, expressed in terms of incremental cost per gynaecological infection prevented; cost-effectiveness acceptability curves presented at alternative willingness-to-pay thresholds for preventing gynaecological infection. RESULTS: There was no significant difference in the incidence of gynaecological infection between groups. The net societal cost per woman was estimated at 1086.20 pounds in the expectant group, 1410.40 pounds in the medical group and 1585.30 pounds in the surgical group. Expectant management had a 97.8% probability of being the most cost-effective management method at a willingness-to-pay threshold of 10,000 pounds for preventing one gynaecological infection, while medical management had a 2.2% probability of being the most cost-effective management method. Expectant management retained the highest probability of being the most cost-effective management method at all willingness-to-pay thresholds of less than 70,000 pounds for preventing one gynaecological infection. CONCLUSIONS: Expectant and medical management of first-trimester miscarriage possess significant economic advantages over traditional surgical management.

Abortion, Spontaneous↗
PubMed2006

Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial).

OBJECTIVE: To ascertain whether a clinically important difference exists in the incidence of gynaecological infection between surgical management and expectant or medical management of miscarriage. DESIGN: Randomised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage. SETTING: Early pregnancy assessment units of seven hospitals in the United Kingdom. PARTICIPANTS: Women of less than 13 weeks' gestation, with a diagnosis of early fetal demise or incomplete miscarriage. INTERVENTIONS: Expectant management (no specific intervention); medical management (vaginal dose of misoprostol preceded, for women with early fetal demise, by oral mifepristone 24-48 hours earlier); surgical management (surgical evacuation). MAIN OUTCOME MEASURES: Confirmed gynaecological infection at 14 days and eight weeks; need for unplanned admission or surgical intervention. RESULTS: 1200 women were recruited: 399 to expectant management, 398 to medical management, and 403 to surgical management. No differences were found in the incidence of confirmed infection within 14 days between the expectant group (3%) and the surgical group (3%) (risk difference 0.2%, 95% confidence interval - 2.2% to 2.7%) or between the medical group (2%) and the surgical group (0.7%, - 1.6% to 3.1%). Compared with the surgical group, the number of unplanned hospital admissions was significantly higher in both the expectant group (risk difference - 41%, - 47% to - 36%) and the medical group (- 10%, - 15% to - 6%). Similarly, when compared with the surgical group, the number of women who had an unplanned surgical curettage was significantly higher in the expectant group (risk difference - 39%, - 44% to - 34%) and the medical group (- 30%, - 35% to - 25%). CONCLUSIONS: The incidence of gynaecological infection after surgical, expectant, and medical management of first trimester miscarriage is low (2-3%), and no evidence exists of a difference by the method of management. However, significantly more unplanned admissions and unplanned surgical curettage occurred after expectant management and medical management than after surgical management. TRIAL REGISTRATION NATIONAL RESEARCH REGISTER: N0467011677/N0467073587.

Abortion, Spontaneous↗
PubMed2005

Invasive fungal infection in very low birthweight infants: national prospective surveillance study.

OBJECTIVE: To describe the epidemiology of invasive fungal infection in very low birthweight (VLBW: <1500 g) infants in the United Kingdom. DESIGN: National prospective surveillance study between February 2003 and February 2004 using the British Paediatric Surveillance Unit reporting system reconciled with cases identified through routine laboratory reporting to the Health Protection Agency (England, Wales, and Northern Ireland), the Scottish Centre for Infection and Environmental Health, and the UK Mycology Reference Laboratory. RESULTS: Ninety four confirmed cases of invasive fungal infection were identified during the surveillance period giving an incidence of estimated annual incidence of 10.0 (95% confidence interval (CI) 8.0 to 12.0) cases per 1000 VLBW live births. Eighty one (86%) of the infants were of extremely low birth weight (ELBW: <1000 g), incidence 21.1 (95% CI 16.5 to 25.7) per 1000 ELBW live births. Candida species, predominantly C albicans and C parapsilosis, were isolated in 93% of cases. Most organisms were isolated from the bloodstream and urinary tract. Death occurred in 41% of the infected infants before 37 weeks postconceptional age. CONCLUSIONS: The incidence of invasive fungal infection in VLBW and ELBW infants in the United Kingdom is lower than reported in previous studies from tertiary centres in North America and elsewhere. The associated late neonatal and post-neonatal death rates are substantially higher than expected in infants without invasive fungal infection. These data may inform decisions about the evaluation and use of antifungal infection control strategies.

Antifungal Agents↗
PubMed2005

Vitamin A supplementation for reducing the risk of mother-to-child transmission of HIV infection.

BACKGROUND: Mother-to-child transmission (MTCT) of HIV is the dominant mode of acquisition of HIV infection for children, currently resulting in more than 2000 new paediatric HIV infections each day worldwide. OBJECTIVES: To assess the effects of antenatal and intrapartum vitamin A supplementation on the risk of MTCT of HIV infection and infant and maternal mortality and morbidity, and the tolerability of vitamin A supplementation. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials, PubMed, EMBASE, AIDSLINE, LILACS, AIDSTRIALS, and AIDSDRUGS, using standardised methodological filters for identifying trials. We also searched reference lists of identified articles, relevant editorials, expert opinions and letters to journal editors, and abstracts or proceedings of relevant conferences; and contacted subject experts, agencies, organisations, academic centres, and pharmaceutical companies. There were no language restrictions. SELECTION CRITERIA: Randomised trials comparing vitamin A supplementation with no vitamin A supplementation in known HIV infected pregnant women. Trials had to include an estimate of the effect of vitamin A supplementation on MTCT of HIV and or any other adverse pregnancy outcome to be included. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial eligibility and quality and extracted data. Effect measures (odds ratio [OR] for binary variables and weighted mean difference [WMD] for continuous variables) with their 95% confidence intervals (CI) were estimated for each study and combined using the fixed effect (Mantel-Haenszel) method, by intention to treat. Heterogeneity between studies was examined by graphical inspection of results followed by a chi-square test of homogeneity. MAIN RESULTS: Four trials, which enrolled 3,033 HIV-infected pregnant women, are included in this review. There was no evidence of an effect of vitamin A supplementation on MTCT of HIV infection (OR 1.14, 95% CI 0.93 to 1.38). There was evidence of heterogeneity between the three trials with information on MTCT of HIV (I(2) =75.7%, P=0.02). While the trials conducted in South Africa (OR 0.98, 95% CI 0.67 to 1.42 at three months) and Malawi (OR 0.78, 95% CI 0.53 to 1.15 at 24 months) did not find evidence that the effect of Vitamin A supplementation was different from that of placebo, the trial in Tanzania did find evidence that vitamin A supplementation increased the risk of MTCT of HIV (OR 1.53, 95% CI 1.15 to 2.04 at 24 months). Vitamin A supplementation significantly improved birth weight (WMD 89.78, 95% CI 84.73 to 94.83), but there was no evidence of an effect of vitamin A supplementation on stillbirths (OR 0.99, 95% CI 0.67 to 1.46), preterm births (OR 0.89, 95% CI 0.71 to 1.11), death by 24 months among live births (OR 1.11, 95% CI 0.88 to 1.40), postpartum CD4 levels (WMD -4.00, 95% CI -51.06 to 43.06), and maternal death (OR 0.49, 95%CI 0.04 to 5.40). AUTHORS' CONCLUSIONS IMPLICATIONS FOR PRACTICE: Currently available evidence do not support the use of vitamin A supplementation of HIV-infected pregnant women to reduce MTCT of HIV, though there is an indication that vitamin A supplementation improves birth weight. IMPLICATIONS FOR RESEARCH: The awaited publication of data from a large trial involving 4,495 HIV infected pregnant women in Harare (Zimbabwe Vitamin A for Mothers and Babies Project), will further clarify the effect of vitamin A supplementation on MTCT of HIV. The current review will be updated as soon as the trial is published.

Female↗
PubMed2005

Vaginal disinfection for preventing mother-to-child transmission of HIV infection.

BACKGROUND: Mother-to-child transmission (MTCT) of HIV infection is one of the most tragic consequences of the HIV epidemic, especially in resource-limited countries, resulting in about 650 000 new paediatric HIV infections each year worldwide. The paediatric HIV epidemic threatens to seriously undermine decade-old child survival programmes. OBJECTIVES: To estimate the effect of vaginal disinfection on the risk of MTCT of HIV and infant and maternal mortality and morbidity, as well as tolerability of vaginal disinfection in HIV-infected women. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Cochrane Pregnancy and Childbirth Register, PubMed, EMBASE, AIDSLINE, LILACS, AIDSTRIALS, and AIDSDRUGS, using standardised methodological filters for identifying trials. We also searched reference lists of identified articles, relevant editorials, expert opinions and letters to journal editors, and abstracts and proceedings of relevant conferences, and contacted subject experts and pharmaceutical companies. There were no language restrictions. SELECTION CRITERIA: Randomised trials or clinical trials comparing vaginal disinfection during labour with placebo or no treatment, in known HIV-infected pregnant women. Trials had to include an estimate of the effect of vaginal disinfection on MTCT of HIV and or infant and maternal mortality and morbidity. DATA COLLECTION AND ANALYSIS: Three authors independently assessed trial eligibility and quality, and extracted data. Meta-analysis was performed using the Yusuf-Peto modification of Mantel-Haenszel's fixed effect method. MAIN RESULTS: Only two trials that included 708 patients met the inclusion criteria. The effect of vaginal disinfection on the risk of MTCT of HIV (OR 0.93, 95% CI 0.65 to 1.33), neonatal death (OR 1.38, 95% CI 0.30 to 6.33), and death after the neonatal period (OR 1.45, 95% CI 0.47 to 4.45) is uncertain. There was no evidence that vaginal disinfection increased adverse effects in mothers (OR 1.15, 95% CI 0.41 to 3.22), and evidence from one trial showed that adverse effects decreased in neonates (OR 0.14, 95% CI 0.07 to 0.31). AUTHORS' CONCLUSIONS: Currently, there is no evidence of an effect of vaginal disinfection on the risk of MTCT of HIV. Given its simplicity and low cost, there is need for a large well-designed and well-conducted randomised controlled trial to assess the additive effect of vaginal disinfection on the risk of MTCT of HIV in antiretroviral treated women.

Disinfection↗
PubMed2005

Antibiotics for treating bacterial vaginosis in pregnancy.

BACKGROUND: Bacterial vaginosis is an imbalance of the normal vaginal flora with an overgrowth of anaerobic bacteria and a lack of the normal lactobacillary flora. Bacterial vaginosis during pregnancy has been associated with poor perinatal outcome and, in particular, preterm birth. Identification and treatment may reduce the risk of preterm birth and its consequences. OBJECTIVES: To assess the effects of antibiotic treatment of bacterial vaginosis in pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (May 2004). SELECTION CRITERIA: Randomized trials comparing antibiotic treatment with placebo or no treatment, or comparing two or more antibiotic regimens in pregnant women with bacterial vaginosis or intermediate vaginal flora. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trials and extracted data independently. We contacted study authors for additional information. MAIN RESULTS: Thirteen trials involving 5300 women were included; all were of good quality. Antibiotic therapy was effective at eradicating bacterial vaginosis during pregnancy (odds ratio (OR) 0.21, 95% confidence interval (CI) 0.19 to 0.24, nine trials of 3895 women). Treatment was not significant in reducing the risk of preterm birth before 37 weeks (OR 0.87, 95% CI 0.74 to 1.03, thirteen trials of 5300 women, and there was significant heterogeneity between trials, p-value 0.002), preterm birth before 34 weeks (OR 1.22, 95% CI 0.67 to 2.19, five trials of 851 women), preterm birth before 32 weeks (OR 1.14, 95% CI 0.76 to 1.70, four trials of 3565 women), or the risk of preterm prelabour rupture of membranes (OR 0.88, 95% CI 0.61 to 1.28, four trials of 2579 women). In women with a previous preterm birth, treatment did not affect the risk of subsequent preterm birth (OR 0.83, 95% CI 0.59 to 1.17, five trials of 622 women, with significant heterogeneity between these trials); however, it may decrease the risk of preterm prelabour rupture of membranes (OR 0.14, 95% CI 0.05 to 0.38, two trials of 114 women, and low birthweight (OR 0.31, 95% CI 0.13 to 0.75, two trials of 114 women). AUTHORS' CONCLUSIONS: Antibiotic treatment can eradicate bacterial vaginosis in pregnancy. However, this review provides little evidence that screening and treating all pregnant women with asymptomatic bacterial vaginosis will prevent preterm birth and its consequences. For women with a previous preterm birth, there is some suggestion that treatment of bacterial vaginosis may reduce the risk of preterm prelabour rupture of membranes and low birthweight.

Anti-Bacterial Agents↗
PubMed2004

Can polyclonal intravenous immunoglobulin limit cytokine mediated cerebral damage and chronic lung disease in preterm infants?

Recent evidence suggests that inflammatory cytokines may play an important role in cerebral and pulmonary injury, especially in preterm infants. Immunomodulatory agents may help to limit such injury by reducing inflammation. Immunoglobulin has multiple anti-inflammatory properties and can modulate the inflammatory cytokine response. New evidence is required to test the hypotheses that prophylaxis or treatment with intravenous immunoglobulin may limit such inflammatory damage.

Adjuvants, Immunologic↗
PubMed2004

Gastrostomy feeding in cerebral palsy: a systematic review.

AIMS: To determine benefits and risks for gastrostomy or jejunostomy feeding compared with oral feeding for children with cerebral palsy. METHODS: Systematic review. SEARCH STRATEGY: electronic databases--Cochrane Library, Medline, Embase, Cinahl, Lilacs, databases of theses, grey literature. INCLUDED: relevant systematic reviews, randomised controlled trials, observational studies, case reports. EXCLUDED: non-systematic reviews and qualitative research. PARTICIPANTS: children with cerebral palsy. INTERVENTION: use of gastrostomy or jejunostomy tube to provide nutrition. OUTCOME: evaluated outcome measures included death, growth, gastro-oesophageal reflux, other complications, psychosocial aspects, and caregiver wellbeing. RESULTS: No relevant systematic reviews or randomised controlled trials were found. Two cohort studies, 15 case series, and eight case reports met the inclusion criteria. Eight studies specifically described percutaneous endoscopic gastrostomy as the intervention. Weight gain resulted from gastrostomy feeding in most cases. There was an approximately fourfold increased risk of death reported in one cohort study for the gastrostomy fed children. Many complications were reported, including potential for increased gastro-oesophageal reflux and fluid aspiration into the lungs. CONCLUSIONS: Benefits associated with gastrostomy or jejunostomy feeding are difficult to assess from the available evidence. Risks of gastrostomy, particularly in relation to surgical complications, have been described but the size of the risk could not be quantified. The finding of a higher death rate for children fed by gastrostomy may merely reflect the greater disability of these compared with orally fed children. Lack of available evidence and the substantial risk of bias in observational studies suggests that a well conducted randomised controlled trial of sufficient size will be needed to answer these problems.

Cerebral Palsy↗
PubMed2003

Granulocyte transfusions for neonates with confirmed or suspected sepsis and neutropaenia.

BACKGROUND: Neonatal sepsis causes significant neonatal mortality and morbidity. Neonates, especially preterm infants, have an immaturity of granulopoeisis and have a limited capacity for progenitor cell proliferation. This results in the frequent occurrence of neutropaenia in septic neonates. Neutropaenic septic neonates have a higher mortality than neonates who are septic but not neutropaenic. Transfusion of granulocytes to septic neutropaenic neonates, therefore, may help reduce mortality and morbidity. OBJECTIVES: The primary objective of this review was to determine the efficacy and safety of granulocyte preparations (granulocyte and buffy coat transfusions) as adjuncts to antibiotics for the treatment of confirmed or suspected sepsis in neonates with neutropaenia in reducing all-cause mortality during hospital stay and adverse neurological outcome at a year of age or later. Secondary objectives were to determine the effects of granulocyte transfusions on length of hospital stay in survivors to discharge, adverse effects (fluid overload, transmission of blood borne infections, pulmonary complications and sensitisation to donor leukocyte antigens) and immunologic outcomes at a year of age or later. SEARCH STRATEGY: Searches for eligible trials were made in September 2002 of the following electronic databases: The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2002), MEDLINE, EMBASE, CINAHL. The proceedings of the Pediatric Academic Societies, which were published in the journal, Pediatric Research, were searched from 1987 onwards. The Cambridge Database of Scientific Abstracts (1982 onwards) and Dissertation Abstracts on disc (1960 onwards) were also searched. Communications with prominent authors in the field and additional searches in the reference lists of identified trials were performed SELECTION CRITERIA: Randomised and quasi-randomised studies were included, if the participants were neonates with suspected or confirmed sepsis and neutropaenia who received granulocyte preparations (granulocyte concentrates prepared by leukophoresis or buffy coat transfusions prepared by simple centrifugation of blood) at any dose or duration compared with placebo or no granulocyte transfusion, each as adjuncts to antibiotics or compared to other adjuncts to antibiotics to treat sepsis (e.g. intravenous immunoglobulin). Studies were included if any of the following outcomes were reported: all-cause mortality during hospital stay, neurological outcome at one year of age or later, length of hospital stay in survivors at discharge, adverse effects or immunological outcome at one year or later DATA COLLECTION AND ANALYSIS: Trials identified by the search strategy were assessed for eligibility for inclusion in the review. Full text versions of the eligible trials were obtained. Data of interest were extracted on paper forms. Relative risk (RR) and risk difference (RD) with 95% confidence intervals using the fixed effects model were reported for dichotomous outcomes. Pre-specified subgroup analyses were done and reported. MAIN RESULTS: Four eligible studies were identified. A total of 44 infants with sepsis and neutropaenia on antibiotics were randomised in three trials to granulocyte transfusions OR placebo/no transfusion. In another trial, 35 infants with sepsis and neutropaenia on antibiotics were randomised to granulocyte transfusion or intravenous immunoglobulin. When granulocyte transfusions were compared with placebo or no transfusion, there was no significant difference in all-cause mortality [typical RR 0.89 (95% CI 0.43, 1.86), typical RD -0.05 (95% CI -0.31, 0.21)]. There was no statistical heterogeneity in the results of the included trials. When granulocyte transfusions were compared with intravenous immunoglobulin, there was a reduction in all-cause mortality of borderline statistical significance [RR 0.06 (95% CI 0.00, 1.04), RD -0.34(95% CI -0.60, -0.09), NNT 2.9 (95% CI 1.7, 11.1)]. Pulmonary complication, seen in four infants (4%), was the only adverse effect reported. This adverse effect was noticed in the two trials which used buffy coat transfusions. None of the trials reported on neurological outcome at one year of age or later, length of hospital stay in survivors to discharge or immunological outcome at one year of age or later. REVIEWER'S CONCLUSIONS: Currently, there is inconclusive evidence from RCTs to support or refute the routine use of granulocyte transfusions in neonates with sepsis and neutropaenia to reduce mortality and morbidity. Researchers can be encouraged to conduct adequately powered multicentre trials of granulocyte transfusions to clarify their role in neonates with sepsis and neutropaenia. Other adjuncts to antibiotics aimed at improving host defence mechanisms such as colony stimulating factors, IVIG and pentoxifylline should also be tested in RCTs.

Granulocytes↗
PubMed2002

Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period.

BACKGROUND: Venous thromboembolic disease (TED), although very rare, is a major cause of maternal mortality and morbidity, hence methods of prophylaxis are often used for women at risk. This may include women delivered by caesarean section, those with a personal or family history of TED and women with inherited or acquired thrombophilias (conditions that predispose people to thrombosis). Many methods of prophylaxis carry a risk of side effects, and as the risk of thromboembolic disease is low, it is possible that the benefits of thromboprophylaxis may be outweighed by harm. Current guidelines for clinical practice are based on expert opinion only, rather than high quality evidence from randomised trials. OBJECTIVES: To determine the effects of thromboprophylaxis in association with pregnancy in women who are pregnant or have recently delivered on the incidence of venous thromboembolic disease and side effects. SEARCH STRATEGY: The register of trials maintained by the Cochrane Pregnancy and Childbirth Group, the Cochrane Controlled Trials Register, MEDLINE, EMBASE and bibliographies of reviews. Date of last search: January 2002. SELECTION CRITERIA: Randomised trials comparing one method of thromboprophylaxis with placebo or no treatment, and randomised trials comparing two (or more) methods of thromboprophylaxis. DATA COLLECTION AND ANALYSIS: Data were extracted independently by all reviewers. Discrepancies were resolved by discussion. MAIN RESULTS: Eight trials involving 649 women were included. Four of them compared methods of antenatal prophylaxis; low molecular weight versus unfractionated heparin (two studies), aspirin plus heparin versus aspirin alone (one study), and unfractionated heparin versus no treatment (one study). Four studies assessed postnatal prophylaxis after caesarean section; one compared hydroxyethyl starch with unfractionated heparin, two compared heparin with placebo (one low molecular weight heparin, one unfractionated heparin) and the other compared unfractionated heparin with low molecular weight heparin. It was not possible to assess the effects of any of these interventions on most outcomes, especially rare outcomes such as death, thromboembolic disease and osteoporosis, because of small sample sizes and the small number of trials making the same comparisons. REVIEWER'S CONCLUSIONS: There is insufficient evidence on which to base recommendations for thromboprophylaxis during pregnancy and the early postnatal period. Large scale randomised trials of currently-used interventions should be conducted.

Female↗
PubMed2002

Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection.

BACKGROUND: At the end of 2000 it was estimated that over 36 million people were living with the human immunodeficiency virus (HIV). This includes 1.4 million children less than 15 years of age. This is one of several reviews assessing the available evidence for preventing mother-to-child transmission of HIV infection. The other reviews will address other interventions, including Caesarean section, breast feeding, vaginal lavage and vitamin A supplementation. OBJECTIVES: To assess which antiretroviral therapies may be effective in decreasing the risk of mother-to-child transmission of HIV infection as well as their effect on neonatal and maternal mortality and morbidity. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. We also searched conference abstracts from the International AIDS Conferences and Conference on Retroviruses and Opportunistic Infections. SELECTION CRITERIA: Randomised trials comparing any antiretroviral therapy aimed at decreasing the risk of mother-to-child transmission of HIV infection with placebo or no treatment, or any two or more antiretroviral therapies or regimens aimed at decreasing the risk of mother-to-child transmission of HIV infection. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: Zidovudine monotherapy Any zidovudine regimen versus placebo significantly reduces the risk of mother-to-child transmission (Peto odds ratio (OR) 0.46, 95% confidence interval (CI) 0.35 to 0.60). Zidovudine also appears to decrease the risk of infant death within the first year of birth (OR 0.57, 95% CI 0.38 to 0.85) and the risk of maternal death (OR 0.32, 95% CI 0.16 to 0.66). There is no evidence that zidovudine influences the incidence of premature delivery (OR 0.86, 95% CI 0.57 to 1.29) or low birth weight (OR 0.74, 95% CI 0.53 to 1.04). The risk of transmission using a 'short-short' course of zidovudine (from 35 weeks in pregnancy for the mother and for the baby until 3 days old) was higher than the risk using a 'long-long' course (from 28 weeks in pregnancy for the mother and for the baby until 6 weeks old), (OR 2.55, 95% CI 1.26 to 5.18). However, the effectiveness of the 'long-short' course (from 28 weeks in pregnancy for the mother and for the baby until 3 days old) and the 'short-long' course (from 35 weeks in pregnancy for the mother and for the baby until 6 weeks old) did not differ from that of the 'long-long' course. Nevirapine One large randomised controlled trial demonstrates that nevirapine given to mothers as a single dose at the onset of labour and to babies as a single dose within 72 hours of birth is more effective than an intrapartum and post-partum regimen of zidovudine (OR 0.51, 95% CI 0.33 to 0.79). When nevirapine is given to mothers already receiving standard antiretroviral therapy, however, there appears to be no additional advantage (OR 1.10, 95% CI 0.42 to 2.86). Combination Therapy Preliminary findings of the effect of combination therapy using zidovudine and lamivudine (3TC) suggest a decrease in the risk of transmission when the combination is given during the antenatal and intrapartum period or during the intrapartum and postpartum period compared with placebo. There is no evidence that intrapartum zidovudine and lamivudine alone are sufficient to decrease the risk of transmission compared with placebo. REVIEWER'S CONCLUSIONS: Implications for practice The randomised trials included in this review provide evidence that short course zidovudine and single-dose nevirapine are effective therapies for reducing mother-to-child transmission of HIV. The challenge for low and middle income countries will be to institute this therapy in practice. In industrialised countries practice has already moved on from the current evidence and combination antiretroviral therapy aimed primarily at preventing disease progression in the mother is the standard of care. Implications for research The potential value of nevirapine used for longer durations in breastfeeding populations should be considered as it may further reduce the risk of mother-to-child transmission, particularly if combined with early weaning. On-going evaluation of combination antiretroviral therapy is essential and will have an immediate benefit for countries with the resources to adopt such treatment. The search for effective, affordable, safe and acceptable alternatives to antiretroviral therapy for reducing mother-to-child transmission in resource poor countries should remain on the research agenda.

Anti-HIV Agents↗
PubMed2002

Vitamin A supplementation for reducing the risk of mother-to-child transmission of HIV infection.

BACKGROUND: Mother-to-child transmission (MTCT) of HIV is the dominant mode of acquisition of HIV infection for children, currently resulting in about 1800 new paediatric HIV infections each day world-wide. This is one of several reviews assessing the available evidence for preventing HIV transmission from an HIV-infected woman to her child. The other reviews assess the effects of antiretroviral therapy, Caesarean section delivery, breast feeding, and vaginal lavage. OBJECTIVES: To assess the effects of antenatal and intrapartum vitamin A supplementation, compared to an appropriate control group, on the risk of MTCT of HIV infection and infant and maternal mortality and morbidity, and the tolerability of vitamin A supplementation. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Cochrane Pregnancy and Childbirth Register, PubMed, EMBASE, AIDSLINE, LILACS, AIDSTRIALS, and AIDSDRUGS, using standardised methodological filters for identifying trials. We also searched reference lists of identified articles, relevant editorials, expert opinions and letters to journal editors, and abstracts or proceedings of relevant conferences; and contacted subject experts, agencies, organisations, academic centres, and pharmaceutical companies. There were no language restrictions. SELECTION CRITERIA: Randomised trials comparing vitamin A supplementation with no vitamin A supplementation in known HIV infected pregnant women. Trials had to include an estimate of the effect of vitamin A supplementation on MTCT of HIV and/or any other pre-specified adverse pregnancy outcome to be included. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility and quality and extracted data. Odds ratios (OR) and 95% confidence intervals (CI) were estimated for binary data and pooled using a fixed effect (Mantel-Haenszel) method. Heterogeneity between studies was examined by graphical inspection of results followed by a chi-square test of homogeneity. MAIN RESULTS: We identified five eligible trials, only two of which included an estimated of the effect of vitamin A supplementation on at least one of the pre-specified outcomes. Based on the two trials, with a total of 1813 participants, there is no evidence that vitamin A supplementation has an effect on MTCT of HIV (OR 1.09, 95% confidence interval (CI) 0.81 to 1.45). There is no evidence of heterogeneity between the trials (p = 0.37), and no evidence of an effect of vitamin A supplementation in HIV-infected pregnant women on stillbirths (OR 1.07, 95% CI 0.63 to 1.80), very preterm births, i.e. born less than 34 weeks gestation (OR 0.86, 95% CI 0.57 to 1.31), all preterm births, i.e. born less than 37 weeks gestation (OR 0.88, 95% CI 0.68 to 1.13), low birth weight, i.e. weighing less than 2500g (OR 0.86, 95% CI 0.64 to 1.17), very low birthweight, i.e. weighing less than 2000g (OR 0.71, 95% CI 0.40 to 1.28), and postpartum CD4 levels (weighted mean difference -4.00, 95% CI -51.06 to 43.06). The effect of vitamin A on maternal mortality could not be assesssed, as there were only three maternal deaths. REVIEWER'S CONCLUSIONS IMPLICATIONS FOR PRACTICE: At the present time there is no conclusive evidence that the antenatal and intrapartum use of vitamin A supplementation to reduce MTCT of HIV and adverse pregnancy outcomes among HIV-infected pregnant women should be recommended. IMPLICATIONS FOR RESEARCH: The current review will be updated as soon as data from ongoing studies become available. This review and the review in progress on vitamin A supplementation in pregnant women of seronegative/unknown HIV status (Kulier 2002) should be considered together in order to shed more light on the effect of vitamin A supplementation on non-HIV related adverse pregnancy outcomes.

Female↗
PubMed2002

Vaginal disinfection during labour for reducing the risk of mother-to-child transmission of HIV infection.

BACKGROUND: Mother-to-child transmission (MTCT) of HIV infection is one of the most tragic consequences of the HIV epidemic, especially in resource-limited countries, resulting in about 650 000 new paediatric HIV infections each year world-wide. The paediatric HIV epidemic threatens to seriously undermine decade-old child survival programmes. This is one of several reviews assessing the available evidence for preventing HIV transmission from an HIV-infected woman to her child. The other reviews assess the effects of antiretroviral therapy, Caesarean section delivery, breast feeding, and vitamin A supplementation. OBJECTIVES: To estimate the effect of vaginal lavage on the risk of MTCT of HIV and infant and maternal mortality and morbidity, as well as tolerability of vaginal lavage in HIV infected women. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Cochrane Pregnancy and Childbirth Register, PubMed, EMBASE, AIDSLINE, LILACS, AIDSTRIALS, and AIDSDRUGS, using standardised methodological filters for identifying trials. We also searched reference lists of identified articles, relevant editorials, expert opinions and letters to journal editors, and abstracts and proceedings of relevant conferences, and contacted subject experts and pharmaceutical companies. There were no language restrictions. SELECTION CRITERIA: Randomised trials or clinical trials comparing vaginal disinfection during labour with placebo or no treatment, in known HIV infected pregnant women. Trials had to include an estimate of the effect of vaginal disinfection on MTCT of HIV and/or any other pre-specified adverse pregnancy outcome to be included. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility and quality, and extracted data. MAIN RESULTS: Only one low quality trial included an estimate of the effect of vaginal disinfection on at least one pre-specified outcome. There was no evidence of an effect of vaginal disinfection on MTCT of HIV (odds ratio 0.93, 95% confidence interval 0.63 to 1.38), and no information was available on the other pre-specified outcomes. REVIEWER'S CONCLUSIONS: There is a need for well-designed randomised controlled trials to estimate the effects of vaginal disinfection on MTCT of HIV.

Disinfection↗
PubMed2001

Titrated oral misoprostol solution for induction of labour: a multi-centre, randomised trial.

OBJECTIVES: To determine the effects of titrated oral misoprostol solution, compared with vaginal dinoprostone. STUDY DESIGN: Open, randomised clinical trial. SETTING: Academic hospitals in South Africa and Liverpool, UK. METHODS: Women undergoing induction of labour after 34 weeks of pregnancy were allocated by randomised, sealed opaque envelopes, to induction of labour with titrated oral misoprostol solution, or two doses of vaginal dinoprostone (2mg) administered six hours apart. Failure to deliver within 24 hours of randomisation was the primary outcome on which the sample size was based. The data were analysed by intention-to-treat. RESULTS: Six hundred and ninety-five women were randomly allocated: 346 to oral misoprostol and 349 to vaginal dinoprostone. There were no significant differences in substantive outcomes. Vaginal delivery within 24 hours was not achieved in 38% of women in the oral misoprostol group and 36% in the vaginal dinoprostone group (RR 1.08; 95% CI 0.89-1.31). The caesarean section rates were 16% and 20%, respectively (RR 0.80; 95% CI 0.58-1.11). Hyperstimulation with fetal heart rate changes occurred in 4% of women in the oral misoprostol group and 3% after vaginal dinoprostone (RR 1.32, 95% CI 0.59-2.98). The response to induction of labour in women with unfavourable cervices was somewhat slower with misoprostol when membranes were intact, and with dinoprostone when membranes were ruptured. There were no differences in neonatal outcome between the two groups. CONCLUSIONS: This new approach to oral misoprostol administration was successful in minimising the risk of uterine hyperstimulation, which has been a feature of misoprostol use for induction of labour, at the expense of a somewhat slower response in women with intact membranes and unfavourable cervices. Misoprostol is not registered for use in pregnant women, and further research is needed to confirm optimal and safe dosages.

Administration, Intravaginal↗
PubMed2000

Interventions for treating genital chlamydia trachomatis infection in pregnancy.

BACKGROUND: Chlamydia trachomatis is a sexually transmitted infection. Mother-to-child transmission can occur at the time of birth and may result in ophthalmia neonatorum or pneumonitis in the newborn. OBJECTIVES: The objective of this review was to assess the effects of antibiotics in the treatment of genital infection with Chlamydia trachomatis during pregnancy with respect to neonatal and maternal morbidity. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register (Cochrane Library issue 1, 1999). SELECTION CRITERIA: Randomised trials of any antibiotic regimen compared with placebo or no treatment or alternative antibiotic regimens in pregnant women with genital Chlamydia trachomatis infection. DATA COLLECTION AND ANALYSIS: Trial quality assessments and data extraction were done independently by two reviewers. Study authors were contacted for additional information. MAIN RESULTS: Eleven trials were included. Trial quality was generally good. Amoxycillin appeared to be as effective as erythromycin in achieving microbiological cure (odds ratio 0.54, 95% confidence interval 0.28 to 1.02). Amoxycillin was better tolerated than erythromycin (odds ratio 0.16, 95% confidence interval 0.09 to 0.30). Clindamycin and azithromycin also appear to be effective, although the numbers of women included in trials are small. REVIEWER'S CONCLUSIONS: Amoxycillin appears to be an acceptable alternative therapy for the treatment of genital chlamydial infections in pregnancy when compared with erythromycin. Clindamycin and azithromycin may be considered if erythromycin and amoxycillin are contra-indicated or not tolerated.

Anti-Bacterial Agents↗
PubMed2000

Interventions for treating gonorrhoea in pregnancy.

BACKGROUND: Neisseria gonorrhoeae can be transmitted from the mother's genital tract to the newborn during birth and can cause gonococcal opthalmia neonatorum. OBJECTIVES: The objective of this review was to assess the effects of antibiotic regimens in the treatment of genital infection with gonorrhoea during pregnancy with respect to neonatal and maternal morbidity. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register were searched. Date of last search: October 1998. SELECTION CRITERIA: Randomised trials of one regimen of antibiotic versus another in pregnant women with culture confirmed genital gonococcal infection. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality were assessed by one reviewer. MAIN RESULTS: Two trials involving 329 women were included. Amoxycillin with probenicid or spectinomycin or ceftriaxone have a similar effect on microbiological cure, defined by negative gonococcal culture. REVIEWER'S CONCLUSIONS: Any of the antibiotic regimens tested in these trials appear to be effective for the treatment of gonorrhoea in pregnancy in terms of their effect on microbiological cure. For women who are allergic to penicillin, this review provides reassurance that treatment with ceftriaxone or spectinomycin appears to be at least as equally effective in producing microbiological cure.

Anti-Bacterial Agents↗