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The effect of barusiban, a selective oxytocin antagonist, in threatened preterm labor at late gestational age: a randomized, double-blind, placebo-controlled trial
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Thornton, Steven, Goodwin, Thomas M., Greisen, Gorm, Hedegaard, Morten and Arce, Joan-Carles (2009) The effect of barusiban, a selective oxytocin antagonist, in threatened preterm labor at late gestational age: a randomized, double-blind, placebo-controlled trial. In: 7th World Congress in Fetal Medicine, Sorrento, Italy, June 22-26, 2008. Published in: American Journal of Obstetrics and Gynecology, Vol.200 (No.6). Article: 627. doi:10.1016/j.ajog.2009.01.015 ISSN 0002-9378.
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Official URL: http://dx.doi.org/10.1016/j.ajog.2009.01.015
Abstract
OBJECTIVE: The objective of the study was to compare barusiban with placebo in threatened preterm labor.
STUDY DESIGN: 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.
CONCLUSION: An intravenous bolus of barusiban was no more effective than placebo in stopping preterm labor in pregnant women at late gestational age.
Item Type: | Conference Item (Paper) | ||||
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Subjects: | R Medicine > RG Gynecology and obstetrics | ||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||
Journal or Publication Title: | American Journal of Obstetrics and Gynecology | ||||
Publisher: | Mosby-Elsevier | ||||
ISSN: | 0002-9378 | ||||
Official Date: | June 2009 | ||||
Dates: |
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Volume: | Vol.200 | ||||
Number: | No.6 | ||||
Number of Pages: | 10 | ||||
Page Range: | Article: 627 | ||||
DOI: | 10.1016/j.ajog.2009.01.015 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access | ||||
Conference Paper Type: | Paper | ||||
Title of Event: | 7th World Congress in Fetal Medicine | ||||
Type of Event: | Conference | ||||
Location of Event: | Sorrento, Italy | ||||
Date(s) of Event: | June 22-26, 2008 |
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