A placebo-controlled randomized trial of the terbutaline pump for prevention of preterm delivery.
To determine the efficacy of the terbutaline pump for the prevention of preterm delivery, patients in preterm labor defined by progressive cervical change underwent intravenous magnesium sulfate tocolysis (with or without oral indomethacin, as necessary), and once labor was arrested, were randomized to one of three treatment arms: terbutaline by pump, saline by pump (blinded), or oral terbutaline. If recurrent preterm labor occurred despite maximization of therapy, the treatment arm was determined and therapy was changed; saline pump and oral terbutaline were switched to terbutaline pump, terbutaline pump was switched to oral terbutaline. Patients who continued to labor were readmitted for aggressive intravenous therapy. Women randomized to the terbutaline pump (n = 15), saline pump (n = 12), and oral terbutaline (n = 15) groups were similar in terms of gravidity, parity, days of tocolysis before study entry, gestational age at entry, and cervical dilatation at entry. The mean gestational age at delivery was the same in all three groups (35 weeks), as were neonatal outcomes. Terbutaline by pump, saline by pump, and oral terbutaline appear equivalent for the prevention of preterm delivery. The terbutaline pump should remain experimental.
Wenstrom
K D
KD
University of Iowa, Department of Obstetrics and Gynecology, Iowa City, USA.
Weiner
C P
CP
Merrill
D
D
Niebyl
J
J
D000284:Administration, Oral; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D002584:Cervix Uteri / Q000187:drug effects; D004338:Drug Combinations; D005260:Female; D005865:Gestational Age; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage / Q000627:therapeutic use; D007231:Infant, Newborn; D007260:Infusion Pumps; D007262:Infusions, Intravenous; D007747:Labor Stage, First / Q000187:drug effects; D008278:Magnesium Sulfate / Q000008:administration & dosage / Q000627:therapeutic use; D007752:Obstetric Labor, Premature / Q000517:prevention & control*; D010298:Parity; D010919:Placebos; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D012008:Recurrence; D016037:Single-Blind Method; D012965:Sodium Chloride; D013726:Terbutaline / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors; D015149:Tocolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use*
D000318:Adrenergic beta-Agonists; D004338:Drug Combinations; D010919:Placebos; D015149:Tocolytic Agents; D012965:Sodium Chloride; D008278:Magnesium Sulfate; D013726:Terbutaline; D007213:Indomethacin