Indomethacin for preterm labor: A randomized comparison of vaginal and rectal-oral routes

Objective: To compare the efficacy of intravaginal and intrarectal plus ora l indomethacin for the treatment of preterm labor. Methods: Between December 1996 and November 1998, 46 eligible gravidas admi tted with singleton pregnancies and idiopathic preterm labor before 33 gest ational weeks were randomized to receive 200 mg of intravaginal or intrarec tal plus oral indomethacin. Results: Twenty-three subjects were allocated to each study group. The inte rval from initiation of treatment to delivery was significantly longer in t he intravaginal indomethacin group (26.5 +/- 5.7 versus 12.6 +/- 3.7 days; P = .007). Delivery was delayed by more than 7 days in 18 of 23 subjects (7 8%) in the intravaginal indomethacin group compared with ten (43% ) in the intrarectal plus oral indomethacin group (P = .03). Birth weights were sign ificantly higher (2306 +/- 436 versus 1862 +/- 232 g: P = .002) and hospita lization in a neonatal intensive care unit (NICU) (3.1 +/- 0.8 versus 9.3 /- 3.7 days; P = .001) and mechanical ventilation (1.4 +/- 0.2 versus 5.3 /- 1.6 days; P = .001) were significantly shorter in the intravaginal indom ethacin group. Conclusion: Intravaginal indomethacin is more effective than intrarectal pl us oral application in delaying preterm labor and is associated with higher birth weights, shorter NICU stays, and shorter intervals of mechanical ven tilation. (C) 2000 by The American College of Obstetricians and Gynecologis ts.