Randomized comparison of nifedipine and placebo in fibronectin-negative women with symptoms of preterm labor and a short cervix (APOSTEL-I Trial)
Vis, Jolande Y; van Baaren, Gert-Jan; Wilms, Femke F; Oudijk, Martijn A; Kwee, Anneke; Porath, Martina M; Scheepers, Hubertina C; Spaanderman, Marc E; Bloemenkamp, Kitty W; van Lith, Jan M; Bolte, Antoinette C; Bax, Caroline J; Cornette, Jérôme; Duvekot, Johannes J; Nij Bijvank, Sebastiaan W; van Eyck, Jim; Franssen, Maureen T; Sollie, Krystyna M; Woiski, Mallory; Vandenbussche, Frank P; van der Post, Joris A; Bossuyt, Patrick M; Opmeer, Brent C; Mol, Ben W
(2015) American Journal of Perinatology, volume 32, issue 5, pp. 451 - 60
(Article)
Abstract
OBJECTIVE: To evaluate whether tocolysis with nifedipine can be omitted in women with symptoms of preterm labor, a shortened cervix, and negative fetal fibronectin test. STUDY DESIGN: A randomized noninferiority trial was performed in all Dutch perinatal centers. Women with symptoms of preterm labor between 24 and 34 weeks, intact
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membranes, cervical length between 10 and 30 mm, and negative fibronectin test were randomly allocated to nifedipine (80 mg/day) or placebo. The primary outcome was delivery within 7 days. Secondary outcomes were severe neonatal morbidity and mortality. We also followed all eligible nonrandomized women. RESULTS: We allocated 37 women to nifedipine and 36 women to placebo. In the nifedipine group, three women (8.1%) delivered within 7 days, compared with one woman (2.8%) in the placebo group (difference -5.3%; one-sided 95% confidence limit 4.5%). Median gestational age at delivery were respectively 37 + 0 (interquartile range [IQR] 34 + 6 to 38 + 5) and 38 + 2 (IQR 37 + 0 to 39 + 6) weeks (p = 0.008). In the nifedipine group, three pregnancies (8.1%) had a poor outcome; there were no poor outcomes in the placebo group. We observed similar trends in eligible nonrandomized women. CONCLUSION: In symptomatic women with preterm labor, a shortened cervix, and negative fibronectin test, placebo treatment is not inferior to tocolysis with nifedipine.
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Keywords: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
ISSN: 0735-1631
Publisher: Thieme Medical Publishers
Note: Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
(Peer reviewed)