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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
A randomized placebo-controlled evaluation of terbutaline for external cephalic version.
Obstetrics and Gynecology 1997 November
OBJECTIVE: To evaluate the efficacy of subcutaneous terbutaline therapy on the success rate of external cephalic version in term gestation.
METHODS: Women with singleton noncephalic gestations were assigned randomly to receive either terbutaline (0.25 mg) or placebo. Physicians were blinded to the assignment. Fifteen to 30 minutes after the study drug was administered, external cephalic version was attempted. It was discontinued after three attempts, for patient discomfort, for fetal heart rate decelerations, or when successful. Patients were discharged home after the procedure and allowed to enter spontaneous labor. Primary outcomes evaluated included initial success of version, presentation in labor, and route of delivery.
RESULTS: One hundred three women were enrolled in the study between January 1994 and June 1995, of whom 52 were assigned to terbutaline and 51 to placebo. External cephalic version was successful in 27 of 52 (52%) women receiving terbutaline compared with 14 of 51 (27%) of those receiving placebo (P = .019). This comparison yielded a relative risk (RR) of 1.9 (95% confidence interval [CI] 1.3, 6.5). Four of the 27 (15%) successful versions in the terbutaline group and three of the 14 (21%) successful versions in the placebo group spontaneously reverted to breech presentation. Ultimately, in labor there were 24 (46%) cephalic presentations in the terbutaline group and 13 (25%) in the placebo group (P = .048, RR 1.84, 95% CI 1.1, 5.8). Cesarean delivery rates were 11 of 41 (27%) for women with successful versions and 58 of 62 (94%) among those with failed versions (P < .001).
CONCLUSION: Terbutaline (0.25 mg) administered subcutaneously before an attempted version in women at term with noncephalic presentations significantly increased the initial success rate of version and the rate of cephalic presentations in labor while decreasing the rate of cesarean delivery.
METHODS: Women with singleton noncephalic gestations were assigned randomly to receive either terbutaline (0.25 mg) or placebo. Physicians were blinded to the assignment. Fifteen to 30 minutes after the study drug was administered, external cephalic version was attempted. It was discontinued after three attempts, for patient discomfort, for fetal heart rate decelerations, or when successful. Patients were discharged home after the procedure and allowed to enter spontaneous labor. Primary outcomes evaluated included initial success of version, presentation in labor, and route of delivery.
RESULTS: One hundred three women were enrolled in the study between January 1994 and June 1995, of whom 52 were assigned to terbutaline and 51 to placebo. External cephalic version was successful in 27 of 52 (52%) women receiving terbutaline compared with 14 of 51 (27%) of those receiving placebo (P = .019). This comparison yielded a relative risk (RR) of 1.9 (95% confidence interval [CI] 1.3, 6.5). Four of the 27 (15%) successful versions in the terbutaline group and three of the 14 (21%) successful versions in the placebo group spontaneously reverted to breech presentation. Ultimately, in labor there were 24 (46%) cephalic presentations in the terbutaline group and 13 (25%) in the placebo group (P = .048, RR 1.84, 95% CI 1.1, 5.8). Cesarean delivery rates were 11 of 41 (27%) for women with successful versions and 58 of 62 (94%) among those with failed versions (P < .001).
CONCLUSION: Terbutaline (0.25 mg) administered subcutaneously before an attempted version in women at term with noncephalic presentations significantly increased the initial success rate of version and the rate of cephalic presentations in labor while decreasing the rate of cesarean delivery.
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