OBJECTIVE: Our purpose was to test the efficacy of antibiotic prophylaxis in women with preterm premature rupture of the membranes who receive antenatal corticosteroids. STUDY DESIGN: A total of 112 women received one of three regimens in a double-blind randomized controlled trial: (1) ampicillin-sulbactam for 72 hours followed by amoxicillin-clavulanate, (2) ampicillin for 72 hours followed by amoxicillin, or (3) placebo. RESULTS: A total of 48.6% of neonates in the placebo group either died or had sepsis or respiratory distress syndrome versus 29.3% in the pooled antibiotic group (p < 0.05) and 26.3% in the ampicillin-sulbactam/amoxicillin-clavulanate subgroup (p < 0.05). All three neonatal deaths occurred in the placebo group (p = 0.03 versus pooled antibiotics). Mean birth weight was significantly greater in the pooled antibiotic group (1773 gm, p = 0.04) and in the ampicillin-sulbactam/amoxicillin-clavulanate subgroup (1870 gm, p = 0.02) than in the placebo group (1543 gm). Antibiotic prophylaxis reduced the need for prolonged ventilation (p = 0.05). CONCLUSIONS:Antibiotic prophylaxis in combination with corticosteroids in preterm premature rupture of membranes significantly lowered the total frequency of neonatal mortality, sepsis, and respiratory distress syndrome and significantly increased birth weight compared with corticosteroids alone.
RCT Entities:
OBJECTIVE: Our purpose was to test the efficacy of antibiotic prophylaxis in women with preterm premature rupture of the membranes who receive antenatal corticosteroids. STUDY DESIGN: A total of 112 women received one of three regimens in a double-blind randomized controlled trial: (1) ampicillin-sulbactam for 72 hours followed by amoxicillin-clavulanate, (2) ampicillin for 72 hours followed by amoxicillin, or (3) placebo. RESULTS: A total of 48.6% of neonates in the placebo group either died or had sepsis or respiratory distress syndrome versus 29.3% in the pooled antibiotic group (p < 0.05) and 26.3% in the ampicillin-sulbactam/amoxicillin-clavulanate subgroup (p < 0.05). All three neonatal deaths occurred in the placebo group (p = 0.03 versus pooled antibiotics). Mean birth weight was significantly greater in the pooled antibiotic group (1773 gm, p = 0.04) and in the ampicillin-sulbactam/amoxicillin-clavulanate subgroup (1870 gm, p = 0.02) than in the placebo group (1543 gm). Antibiotic prophylaxis reduced the need for prolonged ventilation (p = 0.05). CONCLUSIONS: Antibiotic prophylaxis in combination with corticosteroids in preterm premature rupture of membranes significantly lowered the total frequency of neonatal mortality, sepsis, and respiratory distress syndrome and significantly increased birth weight compared with corticosteroids alone.
Authors: Daniel B DiGiulio; Roberto Romero; Juan Pedro Kusanovic; Ricardo Gómez; Chong Jai Kim; Kimberley S Seok; Francesca Gotsch; Shali Mazaki-Tovi; Edi Vaisbuch; Katherine Sanders; Elisabeth M Bik; Tinnakorn Chaiworapongsa; Enrique Oyarzún; David A Relman Journal: Am J Reprod Immunol Date: 2010-03-21 Impact factor: 3.886
Authors: Roberto Romero; Lara A Friel; Digna R Velez Edwards; Juan Pedro Kusanovic; Sonia S Hassan; Shali Mazaki-Tovi; Edi Vaisbuch; Chong Jai Kim; Offer Erez; Tinnakorn Chaiworapongsa; Brad D Pearce; Jacquelaine Bartlett; Benjamin A Salisbury; Madan Kumar Anant; Gerald F Vovis; Min Seob Lee; Ricardo Gomez; Ernesto Behnke; Enrique Oyarzun; Gerard Tromp; Scott M Williams; Ramkumar Menon Journal: Am J Obstet Gynecol Date: 2010-07-31 Impact factor: 8.661
Authors: Roberto Romero; Jezid Miranda; Piya Chaemsaithong; Tinnakorn Chaiworapongsa; Juan P Kusanovic; Zhong Dong; Ahmed I Ahmed; Majid Shaman; Kia Lannaman; Bo Hyun Yoon; Sonia S Hassan; Chong Jai Kim; Steven Jai Korzeniewski; Lami Yeo; Yeon Mee Kim Journal: J Matern Fetal Neonatal Med Date: 2014-09-29