Antibiotic administration to patients with preterm labor and intact membranes: is there a beneficial effect in patients with endocervical inflammation?

OBJECTIVE To determine whether broad-spectrum antibiotic administration to patients with preterm labor and intact membranes is associated with an improvement in neonatal and maternal outcomes, particularly in patients with microbial invasion of the amniotic cavity (MIAC) or endocervical inflammation (ECI). METHODS A prospective clinical trial was conducted in which women in premature labor were alternately allocated to receive either antibiotics or placebo, and information about MIAC and ECI collected. Eighty-four pregnant women between 24 and 34 weeks of gestation with spontaneous preterm labor were enrolled. Exclusion criteria were cervical dilatation greater than 3 cm, clinical chorioamnionitis, abruption, rupture of membranes, vaginal bleeding, and several additional fetal and maternal conditions that may influence perinatal outcome. Amniocentesis was offered to all patients and the cervix and vagina were sampled for microbiological and cytological studies. Eligible patients were allocated to receive either clindamycin-gentamycin or placebo for 7 days. Corticosteroids and tocolysis with beta-adrenergic agents were used according to the standard management of our institution. MIAC was defined as the presence of a positive amniotic fluid culture obtained by trans-abdominal amniocentesis. ECI was diagnosed when a significant increase in the white blood cell count of the endocervical secretions was found. A composite neonatal morbidity/mortality outcome was created, including severe neonatal morbidity (respiratory distress syndrome, asphyxia, sepsis, pneumonia, intraventricular hemorrhage) and mortality. RESULTS Thirty-nine women received antibiotics and 40 received placebo. The prevalence of ECI and MIAC in both groups was comparable (antibiotic group ECI 61.5% (24/39) and MIAC 20.5% (8/39); placebo group ECI 62.5% (25/40) and MIAC 20% (8/40); p > 0.05). Overall, there were no significant differences in maternal infections and composite neonatal outcomes between antibiotic and placebo groups. Women who received antibiotics had a lower rate of subsequent rupture of membranes compared to patients who received placebo (2.6% (1/39) vs. 25% (10/40), respectively; p = 0.007). A sub-analysis showed that among patients with ECI, antibiotic administration was associated with a lower rate of composite neonatal morbidity/mortality outcome compared to those who received placebo (4.2% (1/24) vs. 28% (7/25), respectively; p < 0.05). This association was also present in patients with ECI without MIAC (0% (0/16) vs. 27.8% (5/18); p < 0.05), but not in patients with ECI and MIAC (antibiotic group 12.5% (1/8) vs. placebo group 28.6% (2/7); p > 0.05). CONCLUSIONS The combination of antibiotics used in this study did not improve maternal or perinatal outcome in patients with preterm labor and intact membranes. Further studies are required to determine if women with endocervicitis presenting with preterm labor and intact membranes may benefit from antibiotic administration.