A double-blind placebo-controlled trial of oxytocin receptor antagonist (antocin) maintenance therapy in patients with preterm labor
Article
San Chez-Ramos, L, Valfnzuela, G, Romero, R et al. (1997). A double-blind placebo-controlled trial of oxytocin receptor antagonist (antocin) maintenance therapy in patients with preterm labor
. Acta Diabetologica Latina, 176(1 PART II), S30.
San Chez-Ramos, L, Valfnzuela, G, Romero, R et al. (1997). A double-blind placebo-controlled trial of oxytocin receptor antagonist (antocin) maintenance therapy in patients with preterm labor
. Acta Diabetologica Latina, 176(1 PART II), S30.
San Chez-Ramos, L; Valfnzuela, G; Romero, R; Silver, H; Koltun, W; Millar, L; Wang, J; Smith, J; Creasy, G
abstract
OBJECTIVE: To compare the efficacy of Antocin to placebo maintenance therapy among women with pretenn labor (PTL) who achieved uterine quiescence with intravenous (IV) Antocin therapy. STUDY DESIGN: A multinational study of women with PTL 20-33 6/7 weeks' gestation, with an open-label IV Antocin treatment phase followed by a randomized, double-blind, placebo controlled maintenance treatment phase. Only patients who had uterine quiescence with IV Antocin were randomized to maintenance of Antocin or placebo. Maintenance was by subcutaneous pump as a continuous infusion of 0.23 ml/hr (30mcg/min Antocin) to the end of week 36. Eligible patients with recurrent PTL received subsequent IV Antocin treatment. The primary efficacy endpoint was the number of days from the start of maintenance therapy until the first recurrence of labor. A secondary endpoint was the % of patients receiving subsequent Antocin IV therapy. RESULTS: Enrollment included 649 PTL patients, 517 achieved uterine quiescence, 512 were randomized to maintenance, 261 Antocin and 251 placebo. The median time to first recurrence was 32.6 days Antocin and 27.6 days placebo (p=0.02). Also 23% of Antocin patients vs 31% of placebo patients had at least one subsequent Antocin IV therapy. CONCLUSIONS: Following successful IV treatment with Antocin, subcutaneous maintenance therapy prolonged the interval of time to the first recurrence of labor and reduced the need for subsequent IV therapy for recurrent PTL.
