OBJECTIVE: To determine whether maternal vitamin C and vitamin E supplementation after the premature rupture of membranes is associated with an increase in the latency period before delivery. METHODS: In the present prospective open randomized trial, 229 pregnant women with preterm premature rupture of membranes (PPROM) at ≥ 24.0 and < 34.0 weeks' gestation were randomly assigned to receive either 1,000 mg of vitamin C and 400 IU of vitamin E (n = 126) or a placebo (n = 123). The primary outcome was the latency period until delivery. Analysis was performed on an intention-to-treat basis. RESULTS: No significant differences in demographic or clinical characteristics were observed between the groups. Latency period until delivery was significantly higher in the group that received vitamins compared with the control group (11.2 ± 6.3 days versus 6.2 ± 4.0 days; p < 0.001). Gestational age at delivery was also significantly higher in the vitamin group compared with the control group (31.9 ± 2.6 weeks versus 31.0 ± 2.6 weeks; p = 0.01). No significant differences in adverse maternal outcome (i.e., chorioamnionitis or endometritis) or neonatal outcome (i.e., neonatal sepsis, neonatal death, necrotizing enterocolitis, or grade 3 to 4 intraventricular hemorrhage) were noted between groups. CONCLUSIONS: The findings of the present study suggest that the use of vitamins C and E in women with PPROM is associated with a longer latency period before delivery. Moreover, adverse neonatal and maternal outcomes, which are often associated with prolonged latency periods, were similar between the groups. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
RCT Entities:
OBJECTIVE: To determine whether maternal vitamin C and vitamin E supplementation after the premature rupture of membranes is associated with an increase in the latency period before delivery. METHODS: In the present prospective open randomized trial, 229 pregnant women with preterm premature rupture of membranes (PPROM) at ≥ 24.0 and < 34.0 weeks' gestation were randomly assigned to receive either 1,000 mg of vitamin C and 400 IU of vitamin E (n = 126) or a placebo (n = 123). The primary outcome was the latency period until delivery. Analysis was performed on an intention-to-treat basis. RESULTS: No significant differences in demographic or clinical characteristics were observed between the groups. Latency period until delivery was significantly higher in the group that received vitamins compared with the control group (11.2 ± 6.3 days versus 6.2 ± 4.0 days; p < 0.001). Gestational age at delivery was also significantly higher in the vitamin group compared with the control group (31.9 ± 2.6 weeks versus 31.0 ± 2.6 weeks; p = 0.01). No significant differences in adverse maternal outcome (i.e., chorioamnionitis or endometritis) or neonatal outcome (i.e., neonatal sepsis, neonatal death, necrotizing enterocolitis, or grade 3 to 4 intraventricular hemorrhage) were noted between groups. CONCLUSIONS: The findings of the present study suggest that the use of vitamins C and E in women with PPROM is associated with a longer latency period before delivery. Moreover, adverse neonatal and maternal outcomes, which are often associated with prolonged latency periods, were similar between the groups. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.