Prematurity is the major etiologic factor responsible for long term mental and physical handicaps. Tocolytic agents, particularly beta-sympathomimetic drugs, are routinely employed in patients with premature labor with intact membranes to prevent preterm birth, thereby improving perinatal outcome and decreasing health care costs. However, management of the gravida with preterm premature rupture of the membranes (PT-PROM), which accounts for nearly half of preterm births, remains one of the most controversial obstetrical problems. At what gestational age expectant management should be abandoned in favor of active intervention for delivery remains ill-defined. Likewise, the safety and efficacy of tocolytic agents remains unproven. This proposal is a prospective randomized multicenter study addressing these two issues. Patients between 26 and 34 completed weeks of gestation with documented PROM will be assigned to one of two groups based upon the presence or absence of labor. Patients in each group will then be randomized to receive ritodrine or no therapy. Patients between 34 and 36 weeks of gestation will be similarly divided; those patients in labor will be allowed to deliver while those patients not in labor will be randomized into management by expectant observation or active induction of labor. The study design will enable the comparison of such gestational age dependent perinatal complications as respiratory distress syndrome and intraventricular hemorrhage against the intrauterine risks of infection, umbilical cord prolapse, and fetal death. Maternal infections morbidity and incidence of cesarean section will also be compared. Additionally, how such variables as the phospholipid profile, cervical dilatation, fetal presentation, amniotic fluid volume, and cultures of the cervix and amniotic fluid impact on clinical care alternatives and perinatal morbidity will be assessed.
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