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

Objective: To compare the efficacy of intravaginal and intrarectal plus oral indomethacin for the treatment of preterm labor. Methods: Between December 1996 and November 1998, 46 eligible gravidas admitted with singleton pregnancies and idiopathic preterm labor before 33 gestational weeks were randomized to receive 200 mg of intravaginal or intrarectal plus oral indomethacin. Results: Twenty-three subjects were allocated to each study group. The interval from initiation of treatment to delivery was significantly longer in the 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 (78%) in the intravaginal indomethacin group compared with ten (43%) in the intrarectal plus oral indomethacin group ( P = .03). Birth weights were significantly higher (2306 ± 436 versus 1862 ± 232 g; P = .002) and hospitalization 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 indomethacin group. Conclusion: Intravaginal indomethacin is more effective than intrarectal plus oral application in delaying preterm labor and is associated with higher birth weights, shorter NICU stays, and shorter intervals of mechanical ventilation.