Showing papers by "Peter Brocklehurst published in 2006"

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

Abstract: 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.

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

Abstract: Approximately one in every 7 confirmed early pregnancies ends in first-trimester miscarriage. There is as yet no consensus on how best to. manage either incomplete miscarriage or missed miscarriage (early fetal demise). Conventional surgical evacuation often is complicated by gynecologic infection from retained products of conception, which may culminate in fatal septicemia. No randomized, controlled trial has compared all 3 management options: surgical, medical, and expectant. This economic assessment is based on information on 1200 women enlisted in the MIST trial, a large-scale randomized, controlled trial conducted at 7 hospitals in southern England. Subjects were 1200 women with confirmed pregnancy at less than 13 weeks gestation who received a diagnosis of incomplete or missed miscarriage. Participants were randomly assigned to one of the 3 management methods. Cost-effective estimates were expressed in terms of increased cost per gynecologic infection prevented. No significant group differences were evident in the incidence of gynecologic infection. Expectant management had a 97.8% probability of being the most cost-effective management option, whereas medical management had a 2.2% probability of being the most cost-effective choice. Expectant management remained the most cost-effective choice at all willingness-to-pay thresholds below U.K. £70,000 (U.S. $132,336) for preventing one gynecologic infection. Expectant and medical management of first-trimester miscarriage appears to be economically advantageous over conventional surgical management. Nevertheless, the probability that surgery is the most cost-effective choice did increase as the willingness-to-pay threshold for preventing adverse health outcomes increased. The question remains in each instance whether these results apply to a particular setting.

Risk factors for hospital admission related to excessive and/or prolonged postpartum vaginal blood loss after the first 24 h following childbirth

Abstract: A population case-control study was used to determine risk factors for excessive and/or prolonged vaginal bleeding (described collectively as vaginal loss problems) and uterine infection from 24 h to 3 months postpartum. Data were obtained from women whose maternity care took place in one of two health districts in the south of England. The cases were women remaining in or admitted to hospital with excessive or prolonged vaginal blood loss from 24 h to 3 months postpartum. Two controls for each case were identified; these were women whose delivery was the nearest in time and in the same location as the case delivery. Medical and midwifery records were searched retrospectively to cover hospital admissions for vaginal blood loss problems or uterine infection in postpartum women from 1 January 1994 to 31 December 1995. Data were analysed for 243 cases and 486 controls. Univariable analysis identified 28 variables associated with being a case. Using multivariable analysis, nine factors remained in the final model, with a history of secondary postpartum haemorrhage (PPH) being the most strongly predictive (OR [95% confidence interval] 6.0 [2.1, 16.8]). Vaginal bleeding prior to 24 weeks' gestation (OR 3.0 [1.6, 5.9]), third trimester hospital admission (OR 2.0 [1.4, 2.8]), maternal smoking (OR 2.7 [1.8, 3.9]), a prolonged (OR 3.1 [1.2, 7.5]) or incomplete third stage (OR 2.1 [1.0, 4.4]), and primary PPH (OR 4.7 [1.9, 11.6]) for blood loss >500 mL, were predictive of becoming a case. No significant association was identified for parity (OR 1.1 [0.8, 1.5]) or method of delivery, spontaneous (OR 1.0 [0.7, 1.3]), instrumental (OR 1.4 [0.9, 2.2]) or operative (OR 1.2 [0.8, 1.9]). This is a neglected area of women's health after childbirth, and the value of this study is in the identification of potential risk factors for postpartum morbidity related to vaginal blood loss. Where morbidity occurs, early diagnosis, management and treatment are likely to reduce its extent or duration. It is considered that raising awareness about these factors, both among healthcare professionals and women themselves, may play an important part in the recognition and treatment of postpartum morbidity.

Vitamin A supplementation for reducing the risk of mother-to-child transmission of HIV infection: Cochrane systematic review

Abstract: 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.