A randomized prospective study of the efficacy of a protocol of """"""""active management of labor"""""""" to reduce the incidence of cesarean section in primigravidae is proposed. The essence of this very structured approach to the supervision of labor is first, a strict diagnosis of labor and second the early detection and prompt treatment of uterine inefficiency. The patient population will consist of 1800 clinically normal patients in their first pregnancy recruited prior to 24 weeks gestation. Nine hundred patients will be randomized to receive routine prenatal care, education, and obstetric management in labor. Nine hundred will be randomized to a different, highly standardized comprehensive program or prenatal education and care during labor called active management. The efficacy of this program to alter the rate of first time cesarean sections for both dystocia and fetal distress will be evaluated. Rate ratios will be calculated and 95 % confidence intervals constructed. While this is a randomized clinical trial, confounding is still possible. Potential confounding and modifying variables will be controlled using multivariate logistic regression analysis. A variety of other obstetrical endpoints will be evaluated including length of labor, use of oxytocin, length of stay and maternal complications. Neonatal morbidity including admission to intensive care and the occurrence of seizures, intraventricular hemorrhage, birth trauma and respiratory distress will also be evaluated. Other general obstetric risk factors such as prepregnancy weight, smoking, and drug or alcohol use will be recorded. The results of this study could impact significantly on how routine obstetrical care during labor is managed in this country. With approximately 1,000,000 c-sections performed in the United States last year, any significant decrease would significantly decrease maternal mortality and morbidity. In addition, the financial saving to the entire health care delivery system both directly and indirectly would amount to over one billion dollars per year. With some estimated 375,000 primigravid sections done per year of which 50% are for dystocia, over 60,000 of these alone could be eliminated with this management protocol if the hypothesis is correct.
| Goetzl, Laura; Cohen, Amy; Frigoletto Jr, Fredric et al. (2003) Maternal epidural analgesia and rates of maternal antibiotic treatment in a low-risk nulliparous population. J Perinatol 23:457-61 |
| Gross, Jeffrey B; Cohen, Amy P; Lang, Janet M et al. (2002) Differences in systemic opioid use do not explain increased fever incidence in parturients receiving epidural analgesia. Anesthesiology 97:157-61 |
| Goetzl, L; Cohen, A; Frigoletto Jr, F et al. (2001) Maternal epidural use and neonatal sepsis evaluation in afebrile mothers. Pediatrics 108:1099-102 |
| Lieberman, E; Lang, J; Richardson, D K et al. (2000) Intrapartum maternal fever and neonatal outcome. Pediatrics 105:13-Aug |
| Lieberman, E; Cohen, A; Lang, J et al. (1999) Maternal intrapartum temperature elevation as a risk factor for cesarean delivery and assisted vaginal delivery. Am J Public Health 89:506-10 |
| Lieberman, E; Lang, J M; Frigoletto Jr, F et al. (1997) Epidural analgesia, intrapartum fever, and neonatal sepsis evaluation. Pediatrics 99:415-9 |
| Lieberman, E; Lang, J M; Cohen, A P et al. (1997) The association of fetal sex with the rate of cesarean section. Am J Obstet Gynecol 176:667-71 |
| Lieberman, E; Lang, J M; Cohen, A et al. (1996) Association of epidural analgesia with cesarean delivery in nulliparas. Obstet Gynecol 88:993-1000 |
| Frigoletto Jr, F D; Lieberman, E; Lang, J M et al. (1995) A clinical trial of active management of labor. N Engl J Med 333:745-50 |
