The effect of barusiban, a selective oxytocin antagonist, in threatened preterm labor at late gestational age: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
The objective of the study was to compare barusiban with placebo in threatened preterm labor.


METHODS
This was a randomized, double-blind, placebo-controlled, multicenter study. One hundred sixty-three women at 34-35 weeks plus 6 days, and with 6 or more contractions of 30 seconds duration during 30 minutes, cervical length 15 mm or less, and cervical dilatation > 1 and < 4 cm were randomized to a single intravenous bolus of barusiban (0.3, 1, 3, or 10 mg) or placebo. The primary endpoint was percentage of women who did not deliver within 48 hours.


RESULTS
None of the barusiban doses reduced the number of uterine contractions compared with placebo. There was no significant difference in the percentage of women who did not deliver within 48 hours (72% placebo and 65-88% barusiban groups; P = .21-.84). Barusiban was not associated with an adverse safety profile in the woman, fetus, neonate, or infant.


CONCLUSIONS
An intravenous bolus of barusiban was no more effective than placebo in stopping preterm labor in pregnant women at late gestational age.
Thornton
Steven
S
Warwick Medical School, University of Warwick, Coventry, England, United Kingdom.
Goodwin
Thomas M
TM
Greisen
Gorm
G
Hedegaard
Morten
M
Arce
Joan-Carles
JC
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007752:Obstetric Labor, Premature / Q000517:prevention & control*; D009842:Oligopeptides / Q000627:therapeutic use*; D011247:Pregnancy; D018045:Receptors, Oxytocin / Q000037:antagonists & inhibitors*
D009842:Oligopeptides; D018045:Receptors, Oxytocin; C517339:barusiban