Prophylactic cesarean delivery for the prevention of perinatal human immunodeficiency virus transmission: the case for restraint.
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Biomedical subjects
Publications and source records attributed to D J Rouse.
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CONTEXT: Antenatal corticosteroids for fetal maturation have been underused, despite evidence for their benefits in cases of preterm birth. OBJECTIVE: To evaluate dissemination strategies aimed at increasing appropriate use of this therapy. DESIGN AND SETTING: Twenty-seven tertiary care institutions were randomly assigned to either usual dissemination of practice recommendations (n = 14) or usual dissemination plus an active, focused dissemination effort (n = 13). SUBJECTS: Obstetricians and their preterm delivery cases at participating hospitals. INTERVENTION: Recommendations by a National Institutes of Health (NIH) Consensus Conference held in late February-early March 1994 were disseminated in early May 1994. Usual dissemination was publication of the recommendations and endorsement by the American College of Obstetricians and Gynecologists. Active dissemination was a year-long educational effort led by an influential physician and a nurse coordinator at each facility, consisting of grand rounds, a chart reminder system, group discussion of case scenarios, monitoring, and feedback. MAIN OUTCOME MEASURE: Use or nonuse of antenatal corticosteroids was abstracted from medical records of eligible women delivering at the participating hospitals in the 12 months immediately prior to release of the NIH recommendations (average number of records abstracted, 130) and in the 12 months following their release (average number of records abstracted, 122). RESULTS: Active dissemination significantly increased the odds of corticosteroid use after the conference. Use increased from 33.0% of eligible patients receiving corticosteroids to 57.6%, or by 75% over baseline, in usual dissemination hospitals. Use increased from 32.9% to 68.3%, oran 108% increase, in active dissemination hospitals. Gestational age and maternal diagnosis affected use of the therapy in complex ways. CONCLUSION: An active, focused dissemination effort increased the effectiveness of usual dissemination methods when combined with key principles to change physician practices.
Both our previously performed decision analysis and more recent clinical data considered in the context of our decision analytic framework support the claim that in the pregnancies of women without diabetes the level of intervention and the economic costs of prophylactic cesarean delivery for fetal macrosomia diagnosed by means of ultrasonography are predicted to be excessive. Under the most plausible assumptions, a prophylactic cesarean policy with either a 4000- or 4500-g macrosomia threshold would require more than 1000 cesarean deliveries and millions of dollars to avert a single permanent brachial plexus injury. In the pregnancies of diabetic women, although such policies would be expected to perform appreciably better, their use would nevertheless entail considerable intervention for any benefit achieved. Under most assumptions, hundreds of cesarean deliveries and hundreds of thousands of dollars would be required to avert a single permanent brachial plexus injury. In light of the available data, optimizing the management of shoulder dystocia seems at present to be the most immediate and tenable approach to the prevention of birth-related brachial plexus injury.
OBJECTIVE: To assess a labor-management protocol that mandated at least 4 hours of oxytocin augmentation before cesarean delivery for active-phase labor arrest. METHODS: We prospectively evaluated term gravidas in spontaneous labor with active-phase labor arrest (cervix at least 4 cm dilated and 1 cm or less of cervical progress in 2 hours). Exclusion criteria included nonvertex presentation, previous cesarean, multiple gestation, and a nonreassuring fetal heart rate tracing or chorioamnionitis at the time of labor arrest. After the diagnosis of active-phase arrest, oxytocin was initiated with an intent to achieve a sustained uterine contraction pattern of greater than 200 Montevideo units. Cesarean delivery was not performed for labor arrest until at least 4 hours of a sustained uterine contraction pattern of greater than 200 Montevideo units, or a minimum of 6 hours of oxytocin augmentation if this contraction pattern could not be achieved. RESULTS: Five hundred forty-two women were managed by the protocol, and 92% delivered vaginally. The subsequent vaginal delivery rate for parous women who had not progressed (1 cm of cervical dilation or less) despite 2 hours of oxytocin augmentation was 91%, and it was 74% for nulliparas. With no labor progress after 4 hours of oxytocin augmentation, the subsequent vaginal delivery rates were 88% for parous women and 56% for nulliparas. There were no severe maternal complications. One neonate had persistent fetal circulation and one had a positive blood culture, but both did well. CONCLUSION: Extending the minimum period of oxytocin augmentation for active-phase labor arrest from 2 to at least 4 hours was effective and safe.
OBJECTIVE: To assess the potential effectiveness and costs of a program to prevent vertical transmission of human immunodeficiency virus (HIV) in parturients without prenatal care. METHODS: A decision-analysis model was constructed to compare three management strategies for unregistered women presenting in labor: 1) the current standard of treating no one; 2) HIV testing with a rapid antibody assay, followed by zidovudine treatment according to AIDS Clinical Trial Group Protocol 076 if seropositive; and 3) treating all women without rapid testing. Cost and probability data were obtained from a literature review and local estimates. Sensitivity analyses were performed for pertinent uncertainties. RESULTS: Under baseline assumptions (5% HIV prevalence, treatment efficacy of an 18% reduction in transmission rate, and lifetime cost of pediatric HIV $103,708), giving no treatment resulted in 1275 infected infants per 100,000 mother-infant pairs. The rapid-test strategy prevented 183 cases of infant HIV infection and resulted in a net savings to the medical system of $57,997 per case averted. The treat-all strategy prevented an additional 46 cases per 100,000 mother-infant pairs, but at a cost of $342,068 per additional case averted. With other estimates at baseline, rapid testing was cost-saving when the HIV prevalence exceeded 0.97%, the treatment efficacy exceeded a 5.8% reduction in the transmission rate, and the lifetime cost of pediatric HIV infection exceeded $33,625. CONCLUSION: Rapid HIV testing of unregistered parturients followed by zidovudine treatment if seropositive would be cost saving to the medical system.
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Because automated blood cell counters are now widely used in many clinical settings, an assessment of hemoglobin concentration or hematocrit is invariably accompanied by a platelet count. Thus many asymptomatic pregnant women are being screened for thrombocytopenia. The objective of a good screening program is to reduce morbidity and mortality and thereby improve the quality of life; criteria for the evaluation of proposed or ongoing screening programs are well established. However, the screening of pregnant women for thrombocytopenia seems to have been both technologically mandated and passively accepted. Therefore we systematically evaluated the current de facto screening of asymptomatic pregnant patients for thrombocytopenia in the context of well-explained, desirable characteristics for a successful screening program. We conclude that screening for thrombocytopenia in pregnancy fails to meet established criteria, may actually be harmful (by placing unaffected fetuses of thrombocytopenic women, and the women themselves, at risk from invasive procedures), and should therefore be discontinued.
OBJECTIVE: To determine whether intraoperative hypothermia during cesarean delivery is a risk factor for wound infection. METHODS: Eighteen cases with wound infection and 18 controls matched for age, weight, presence of gestational hypertension, and surgery length were selected from a cohort of 900 women who underwent cesarean delivery and who were assessed for wound infection according to strict criteria. Because immediate postoperative temperatures reflect intraoperative temperature nadir accurately and were available universally, we compared the mean immediate postoperative temperatures between cases and controls. RESULTS: In addition to the intentionally matched factors, the groups were well-matched for race, parity, presence of labor, presence of meconium, and duration of membrane rupture. The mean initial postoperative temperatures were similar between the two groups (36.3+/-0.9C versus 36.6+/-1.0C, respectively; P=.8). This study had a power of 90% to detect an intergroup difference of 1C. CONCLUSION: In this case-control study of cesarean delivery, intraoperative hypothermia was not a risk factor for wound infection.
OBJECTIVE: To determine the contemporary antibiotic susceptibility profile of vertically acquired group B streptococcal isolates. METHODS: Susceptibility to ampicillin, penicillin G, erythromycin, clindamycin, cefazolin, and gentamicin was assessed by two methods, minimal inhibitory concentration and disc diffusion. RESULTS: The susceptibility profiles of 119 colonizing and eight invasive strains of group B streptococcus isolated from January 1996 to September 1997 at two hospitals in Birmingham, Alabama-University of Alabama at Birmingham and Cooper Green-were studied. Minimal inhibitory concentration determinations indicated that all colonizing strains were susceptible or moderately susceptible to ampicillin and penicillin G. Resistance was noted by at least one strain to each of the other antibiotics; all were resistant to gentamicin, whereas 27 (21%) were resistant to erythromycin, five (4%) to clindamycin, and one (1%) to cefazolin. All of the eight invasive strains were susceptible or moderately susceptible to ampicillin, penicillin G, clindamycin, and cefazolin; one (13%) was resistant to erythromycin, and all were resistant to gentamicin. Disc diffusion results generally were concordant with minimal inhibitory concentration results, although by disc diffusion fewer isolates were classified as susceptible, and more as moderately susceptible, to ampicillin and penicillin G than by minimal inhibitory concentration. CONCLUSION: Universal susceptibility of group B streptococcus to members of the penicillin family supports the continued use of penicillin G or ampicillin for early onset neonatal group B streptococcal disease prevention. For patients allergic to beta-lactam agents, clindamycin (4% resistance) may be a better alternative than erythromycin (21% resistance).
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OBJECTIVE: Our purpose was to determine whether chlorhexidine vaginal irrigation prevents maternal peripartal infection. STUDY DESIGN: A double-blinded, placebo-controlled, randomized trial was performed. Single 200 ml irrigations of either 0.2% chlorhexidine solution or sterile water placebo were given in active labor or before planned cesarean delivery. The primary outcome measure was the combined rate of chorioamnionitis and endometritis (which were mutually exclusive diagnoses). RESULTS: A total of 1024 patients were enrolled: 508 in the chlorhexidine group and 516 in the placebo group. The two groups were generally well balanced on important clinical factors but differed (p < 0.05) in rates of nulliparity (chlorhexidine 42%, placebo 52%), intrauterine pressure catheter usage (chlorhexidine 65%, placebo 72%), and presence of meconium (chlorhexidine 17%, placebo 22%). There were no recognized adverse maternal or neonatal reactions to irrigation. Rates of infection (chorioamnionitis + endometritis) did not differ significantly between the groups, chlorhexidine 10% versus placebo 13% (relative risk 0.8, 95% confidence interval 0.5 to 1.1). Stratified and logistic regression analyses supported the primary univariate analysis. Neonatal outcomes, including sepsis rates of 0.4%, were equivalent for the groups. CONCLUSION: As used in this trial, chlorhexidine lacked efficacy in the prevention of maternal peripartal infection.
OBJECTIVE: To estimate the pediatric costs associated with the Centers for Disease Control and Prevention (CDC) guidelines for the management of infants born to mothers receiving intrapartum antimicrobial prophylaxis for prevention of early-onset group B streptococcal disease. METHODS: For an annual United States birth cohort of 3.95 million infants, we estimated the cost of pediatric care provided to full-term asymptomatic infants when pediatricians followed the CDC algorithm for the management of infants exposed to intrapartum antimicrobial prophylaxis under culture-based and risk factor-based maternal care approaches. We calculated the relative contribution of pediatric costs to the total costs of preventing a case of early-onset group B streptococcal sepsis. RESULTS: Total pediatric costs were $41 million for a culture-based approach and $33 million for a risk factor-based approach. Hospital and physician costs accounted for more than 78% of this total. The majority (over 95%) of the pediatric costs were associated with vaginal deliveries. Incorporating pediatric costs into previous cost-effectiveness analyses increased the cost per sepsis case averted by as much as 51% for culture-based strategies and by as much as 112% for risk factor-based strategies. Pediatric costs varied with the average length of stay for full-term infants and with the average cost of a hospital day. CONCLUSION: Substantial pediatric costs are associated with the implementation of an obstetric strategy for minimizing the risk of early-onset group B streptococcal disease. Such costs should be included in future cost-effectiveness analyses of different strategies for minimizing the risk of group B streptococcal disease in newborns.
Thromboembolic disease is a leading cause of maternal mortality in the United States. Recently, inherited resistance to activated protein C has been recognized as a major risk factor for thrombosis and has been demonstrated in 20-60% of patients with clinically evident thrombosis. The factor V Leiden mutation, which is readily detectable by molecular DNA techniques, is responsible for 90-95% of cases of activated protein C resistance. Because 5% of whites and 1% of blacks in the United States are heterozygous for the Leiden mutation, at least one group has suggested that screening of asymptomatic gravidas for the mutation should be considered. Therefore, we conducted a combined MEDLINE and bibliographic literature search for relevant data and evaluated screening for the factor V Leiden mutation in the context of well-elucidated desirable characteristics for a successful screening program. Based on this evaluation, we conclude that routine antenatal screening for the factor V Leiden mutation cannot be recommended at the present time.
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OBJECTIVE: To quantitate the potential effectiveness and monetary costs of a policy of elective cesarean delivery for fetal macrosomia diagnosed by ultrasound. DESIGN: A decision analytic model was constructed to compare 3 policies: (1) management without ultrasound; (2) ultrasound and elective cesarean delivery for estimated fetal weight of 4000 g or more (4000-g policy); and (3) ultrasound and elective cesarean delivery for estimated fetal weight of 4500 g or more (4500-g policy). The impact of maternal diabetes was analyzed separately. Probability data used in the decision analytic model were summarized from the literature and supplemented with unpublished data from the Collaborative Trial of Preterm Birth Prevention. Costs were estimated from the literature, regional reimbursements, and clinical practice data. MAIN OUTCOME MEASURES: Rates of shoulder dystocia and permanent brachial plexus injury, and both the number of additional cesarean births and monetary costs per permanent brachial plexus injury averted. RESULTS: In the baseline analysis for nondiabetic women, the ultrasound policies increased both the cesarean delivery rate and costs, while decreasing the rate of shoulder dystocia and brachial plexus injury. For each permanent brachial plexus injury prevented by the 4500-g policy, 3695 cesarean deliveries were performed at an additional cost of $8.7 million, vs 2345 cesarean deliveries and $4.9 million with the 4000-g policy. In the baseline analysis for diabetic women, with all 3 policies, rates of cesarean delivery, shoulder dystocia and brachial plexus injury, and total costs were higher than for nondiabetic women. However, more favorable ratios for both cesarean deliveries and cost per permanent injury avoided were observed: 443 deliveries and $930 000, respectively, with the 4500-g policy, and 489 deliveries and $880 000, respectively, with the 4000-g policy. Sensitivity analysis confirmed the general robustness of these findings. CONCLUSIONS: For the 97% of pregnant women who are not diabetic, a policy of elective cesarean delivery for ultrasonographically diagnosed fetal macrosomia is medically and economically unsound. In pregnancies complicated by diabetes, such a policy appears to be more tenable, although the merits of such an approach are debatable.
OBJECTIVE: To compare the cost-effectiveness and cost-benefit of different strategies for managing the presumed susceptible varicella (chickenpox)-exposed gravida. METHODS: Three strategies were evaluated: 1) a do-nothing or observation strategy; 2) a testing strategy, in which immune status was assessed and varicella-zoster immune globulin was administered to those who tested nonimmune; and 3) a universal-administration strategy, in which varicella-zoster immune globulin was given to all exposed, presumed susceptible gravidas. Because precise data are unavailable about varicella mortality and hospitalization rates in pregnancy, a range of potential rates was evaluated, from one to greater than 20 times healthy nonpregnant adult rates. The potential efficacy of varicella-zoster immune globulin varied from 1 to 99%. A strategy was defined as cost-effective if it cost less than $50,000 per life-year gained. RESULTS: If the mortality rate from varicella infection in pregnancy was increased fivefold over the nonpregnant healthy adult rate (ie, from 31/100,000 to 155/100,000 cases), efficacy would have to be at least 49% for the immune-testing strategy to be cost-effective. If pregnancy only doubled the varicella mortality rate, then even with perfect efficacy, the immune-testing strategy would not be cost-effective. Under most assumptions, the universal-administration strategy was cost-ineffective when compared with the immune-testing strategy. Similar results were obtained in the parallel cost-benefit analysis, which considered hospitalization costs and rates. The analysis was sensitive to the varicella transmission rate and the discount rate. CONCLUSION: From a cost-effectiveness/cost-benefit standpoint, management based on immune testing is preferable to universal varicella-zoster immune globulin administration when caring for the varicella-exposed gravida with a negative or indeterminate infection history.
OBJECTIVE: To compare the economic costs between two strategies for management of the small unruptured ectopic pregnancy: initial treatment with methotrexate versus initial treatment with laparoscopic salpingostomy. METHODS: We assumed that both treatment strategies would result in identical clinical outcomes: resolution of the ectopic pregnancy without maternal mortality or long-term morbidity. Based on a literature review, estimates were derived for the likely clinical outcomes of a single injection of methotrexate (50 mg/m2) and for the likely clinical outcomes of the laparoscopy strategy. A range of values was evaluated for the initial success rate of each strategy and varying assumptions made about the type of treatment modality used for initial treatment failures. Direct medical costs of each strategy were estimated based on actual reimbursement rates of a third-party payer for the components of each strategy. The treatment strategies were compared in best-case/worst-case scenarios to determine the potential range of differences in costs between the two strategies. RESULTS: The cost of the methotrexate strategy ranged from $438 to $1390, and the cost of laparoscopic salpingostomy ranged from $2506 to $2974; therefore, the methotrexate strategy was less costly than laparoscopy, with a cost difference ranging from $1124 (best-case laparoscopy-worst-case methotrexate scenario) to $2536 (worst-case laparoscopy-best-case methotrexate scenario). Sensitivity analyses demonstrated that initial therapy with methotrexate was less costly over a wide range of probability and cost estimates. CONCLUSION: Initial methotrexate is a cost-effective alternative to laparoscopic salpingostomy in the treatment of the small unruptured ectopic pregnancy.