A double-blind randomized study of fetal side effects during and after the short-term maternal administration of indomethacin, sulindac, and nimesulide for the treatment of preterm labor

Sawdy, Robert J., Lye, Shiromi, Fisk, Nicholas M. and Bennett, Phillip R. (2003) A double-blind randomized study of fetal side effects during and after the short-term maternal administration of indomethacin, sulindac, and nimesulide for the treatment of preterm labor. American Journal of Obstetrics and Gynecology, 188 4: 1046-1051. doi:10.1067/mob.2003.255


Author Sawdy, Robert J.
Lye, Shiromi
Fisk, Nicholas M.
Bennett, Phillip R.
Title A double-blind randomized study of fetal side effects during and after the short-term maternal administration of indomethacin, sulindac, and nimesulide for the treatment of preterm labor
Journal name American Journal of Obstetrics and Gynecology   Check publisher's open access policy
ISSN 0002-9378
1097-6868
Publication date 2003-04-01
Year available 2003
Sub-type Article (original research)
DOI 10.1067/mob.2003.255
Open Access Status
Volume 188
Issue 4
Start page 1046
End page 1051
Total pages 6
Editor Thomas J. Garite
Moon H. Kim
Place of publication St. Louis, MO, U.S.A.
Publisher Mosby
Language eng
Subject 111402 Obstetrics and Gynaecology
1114 Paediatrics and Reproductive Medicine
Abstract OBJECTIVE: The purpose of this study was to establish whether nimesulide causes fewer fetal side effects than indomethacin or sulindac after short-term maternal exposure for tocolysis.
Formatted abstract
Objective: The purpose of this study was to establish whether nimesulide causes fewer fetal side effects than indomethacin or sulindac after short-term maternal exposure for tocolysis.
Study Design: This was a double-blind, double-dummy prospective randomized study with three drug treatment groups (n = 10 per group) that were comprised of subjects who were at 28 to 32 weeks of gestation with preterm contractions. The subjects were treated in the delivery suites of two busy inner-city teaching hospitals; the intervention consisted of 48 hours of treatment and with 72 hours of follow-up observation with indomethacin 100 mg (twice daily), sulindac 200 mg (twice daily), or nimesulide 200 mg (twice daily). The amniotic fluid index, hourly fetal urine production, and ductal Doppler pulsatility index observations were monitored before the treatment and at 4, 24, 48, 72, and 120 hours after the treatment was started. The statistical analysis used repeated measures analysis of variance, Bonferroni test, and Bland-Altman agreement. Significance assumed when the probability value was <.05.
Results: Each drug caused a significant reduction in all three observations over the 48-hour treatment period, which recovered to pretreatment levels by 72 hours after treatment. There were no significant differences among drugs for any of these effects.
Conclusion
: Nimesulide causes similar short-term fetal side effects to indomethacin and sulindac.
Copyright © 2003 Mosby, Inc. All rights reserved.

Keyword Fetus
Adverse effect
Nimesulide
Indomethacin
Sulindac
Renal function
Ductus arteriosus
Tocolysis
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Unknown

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
School of Medicine Publications
 
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Created: Thu, 19 Mar 2009, 22:11:59 EST by Mary-Anne Marrington on behalf of UQ Centre for Clinical Research