Objective
Our aim was to estimate if indomethacin therapy prevents preterm birth (PTB) in women
with a short cervical length (CL) on transvaginal ultrasound (TVU).
Study design
Individual-level data from all randomized trials including asymptomatic women with
a short CL on TVU were analyzed for use of indomethacin at the time of the short CL.
The trials eligible would be ones that randomized women with a short CL <25 mm, identified
between 14 and 27 weeks. The eligible trials randomized such women to receive either
cerclage or no cerclage. Only women who did NOT receive cerclage were analyzed. Exclusion
criteria were major fetal anomaly and cerclage. We compared demographics, risk factors,
and outcomes in women who, at the time of the short CL, received indomethacin or not.
Primary outcome was PTB <35 weeks.
Results
Three of the 4 randomized trials identified had databases which recorded indomethacin
use at the time of the short CL. A total of 139 women with a short CL <25 mm identified
at 14 to 27 weeks were identified. Of these women, 99 (71.2%) received indomethacin,
and 40 (28.8%) did not. Demographics and risk factors, including previous PTB (45.5%
vs 62.5%; P = .11), were similar in the 2 groups. The primary outcome of PTB <35 weeks occurred
in 29.3% (29/99) of women who received indomethacin, and 42.5% (17/40) of women who
did not receive indomethacin (RR 0.69, 95% CI 0.44-1.13). PTB <24 weeks occurred in
1.0% (1/99) versus 7.5% (3/40), respectively (RR 0.14; 95% CI 0.02-0.92). Incidence
of perinatal death was similar in the 2 groups (6% vs 10%; RR 0.61, 95% CI 0.19-1.95).
Conclusion
Indomethacin therapy for asymptomatic women who have a short CL <25 mm on TVU at 14
to 27 weeks and do not receive a cerclage did not prevent spontaneous PTB <35 weeks,
but did prevent PTB <24 weeks. Further research including larger numbers and a randomized
trial design is necessary to further clarify the effectiveness as well as the risks
of this therapy.
Key words
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Article Info
Publication History
Accepted:
June 1,
2006
Received in revised form:
May 8,
2006
Received:
March 9,
2006
Footnotes
Presented at the Twenty-Sixth Annual Meeting of the Society for Maternal Fetal Medicine, Miami, FL, January 30-February 4, 2006.
Reprints not available from the authors.
Identification
Copyright
© 2006 Mosby, Inc. Published by Elsevier Inc. All rights reserved.