No Difference in Outcomes with Early vs. Late Antibiotic Prophylaxis for Term PROM: A Multi-Center Analysis.

Abstract

Background: While guidelines suggest administering antibiotics 12 to 18 hours after the rupture of membranes in term premature rupture of membranes (PROM) women, in practice, clinicians tend to initiate prophylactic antibiotics as soon as possible to avoid risk of infection.

Objective: This study aimed to assess whether early administration of prophylactic antibiotics for term premature rupture of membranes reduces the incidence of maternal and neonatal infections.

Study design: This multi-center, prospective cohort study included women with term premature rupture of membranes. Participants were divided into early and late administration groups according to the duration between membranes rupture and antibiotic use. The effectiveness outcomes included the incidence of puerperal infection, the incidence of total maternal infection, the rate of neonatal sepsis, among others; the safety outcomes included the incidence of adverse reactions; and Antibiotics Use Density was used to assess the antibiotic consumption. Propensity score matching method was used to control confounding.

Results: A total of 1099 women with term PROM were enrolled, 459 in the early group-6 hours (antibiotics administration within 6 hours) and 640 in the late group-6 hours (antibiotics administration after 6 hours); 707 in the early group-12 hours (antibiotics administration within 12 hours) and 392 in the late group-12 hours (antibiotics administration after 12 hours). After propensity score matching, there were 300 women in each of the 6-hour groups and 230 women in each of the 12-hour groups. Baseline characteristics showed no significant differences between matched groups (P>0.05). The early 6-hour and 12-hour groups had lower maternal C-reactive protein levels compared to the late groups (P<0.05), but no significant differences in other maternal and neonatal outcomes. Adverse reactions showed no statistical significance between early and late groups (P=1.000). Antibiotic use density was higher in the early treatment groups by 10.1 defined daily doses (DDDs) (6-hour) and 11.7 DDDs (12-hour).

Conclusion: There was no statistical difference in the efficacy and safety when antibiotics administered within 6-12 hours after rupture of membranes, compared to after 6-12 hours in women with term PROM. Meanwhile delayed use significantly reduces the antibiotic consumption.