%0 Journal Article %1 Rouse1996 %A Rouse, D. J. %A Hauth, J. C. %A Nelson, K. G. %A Goldenberg, R. L. %D 1996 %J Am J Obstet Gynecol %K Cerebral Palsy; Feasibility Studies; Female; Gestational Age; Humans; Infant Mortality; Infant, Newborn; Magnesium Sulfate; Obstetric Labor, Premature; Pregnancy; Randomized Controlled Trials; Research Design; Sample Size %N 3 Pt 1 %P 701--705 %T The feasibility of a randomized clinical perinatal trial: maternal magnesium sulfate for the prevention of cerebral palsy. %V 175 %X OBJECTIVE: Because recent epidemiologic data suggest an association between maternal magnesium sulfate use and a decreased risk of cerebral palsy in infants who survive preterm birth, we investigated the feasibility of a randomized trial of intrapartum maternally administered magnesium sulfate to prevent cerebral palsy in children who were born before term. STUDY DESIGN: On the basis of a literature review, we calculated cumulative rates of delivery, neonatal survival, and cerebral palsy for progressively longer gestational age intervals beginning at 24 weeks' gestation. Sample size estimates with two-tailed chi 2 tests without Yates' correction (alpha = 0.05, beta = 0.2, 50\% effect size) for a clinical trial were calculated for these rates. RESULTS: In the 4-week interval from 24 weeks 0 days to 27 weeks 6 days the minimum number of neonates required to conduct a randomized trial would be 1189. Loss to follow-up of neonates, maternal ineligibility, and failure of enrollment would substantially increase the number of necessary gravid women delivered in the 4-week interval to complete such a trial, such that 1 million pregnancies would be required to generate the necessary number of eligible gravid women. Shorter gestational age intervals (e.g., 24 weeks 0 days to 25 weeks 6 days) required fewer neonates (n = 729) but more pregnancies (n = 1.5 million). Because of the decreasing prevalence of cerebral palsy at higher gestational ages, extending the gestational age interval (e.g., to 29 weeks 6 days) markedly increased the minimum number of neonates to 1982 but only slightly decreased the necessary number of pregnancies, to 900,000. CONCLUSIONS: A randomized trial of maternally administered intrapartum magnesium sulfate to reduce the rate of cerebral palsy in surviving preterm neonates would be a formidable undertaking, requiring a concerted multicentered effort.

@article{Rouse1996, abstract = {OBJECTIVE: Because recent epidemiologic data suggest an association between maternal magnesium sulfate use and a decreased risk of cerebral palsy in infants who survive preterm birth, we investigated the feasibility of a randomized trial of intrapartum maternally administered magnesium sulfate to prevent cerebral palsy in children who were born before term. STUDY DESIGN: On the basis of a literature review, we calculated cumulative rates of delivery, neonatal survival, and cerebral palsy for progressively longer gestational age intervals beginning at 24 weeks' gestation. Sample size estimates with two-tailed chi 2 tests without Yates' correction (alpha = 0.05, beta = 0.2, 50\% effect size) for a clinical trial were calculated for these rates. RESULTS: In the 4-week interval from 24 weeks 0 days to 27 weeks 6 days the minimum number of neonates required to conduct a randomized trial would be 1189. Loss to follow-up of neonates, maternal ineligibility, and failure of enrollment would substantially increase the number of necessary gravid women delivered in the 4-week interval to complete such a trial, such that 1 million pregnancies would be required to generate the necessary number of eligible gravid women. Shorter gestational age intervals (e.g., 24 weeks 0 days to 25 weeks 6 days) required fewer neonates (n = 729) but more pregnancies (n = 1.5 million). Because of the decreasing prevalence of cerebral palsy at higher gestational ages, extending the gestational age interval (e.g., to 29 weeks 6 days) markedly increased the minimum number of neonates to 1982 but only slightly decreased the necessary number of pregnancies, to 900,000. CONCLUSIONS: A randomized trial of maternally administered intrapartum magnesium sulfate to reduce the rate of cerebral palsy in surviving preterm neonates would be a formidable undertaking, requiring a concerted multicentered effort.}, added-at = {2014-07-19T21:10:40.000+0200}, author = {Rouse, D. J. and Hauth, J. C. and Nelson, K. G. and Goldenberg, R. L.}, biburl = {https://www.bibsonomy.org/bibtex/260eba86ecdace6f829eaca1873da9fea/ar0berts}, groups = {public}, interhash = {fe7133af8248881d04afae80d9dac6ac}, intrahash = {60eba86ecdace6f829eaca1873da9fea}, journal = {Am J Obstet Gynecol}, keywords = {Cerebral Palsy; Feasibility Studies; Female; Gestational Age; Humans; Infant Mortality; Infant, Newborn; Magnesium Sulfate; Obstetric Labor, Premature; Pregnancy; Randomized Controlled Trials; Research Design; Sample Size}, month = Sep, number = {3 Pt 1}, pages = {701--705}, pii = {S0002-9378(96)00480-2}, pmid = {8828437}, timestamp = {2014-07-19T21:10:40.000+0200}, title = {The feasibility of a randomized clinical perinatal trial: maternal magnesium sulfate for the prevention of cerebral palsy.}, username = {ar0berts}, volume = 175, year = 1996 }