TY - JOUR
T1 - Randomized comparison of nifedipine and placebo in fibronectin-negative women with symptoms of preterm labor and a short cervix (APOSTEL-I Trial)
AU - Vis, Jolande Y.
AU - Van Baaren, Gert Jan
AU - Wilms, Femke F.
AU - Oudijk, Martijn A.
AU - Kwee, Anneke
AU - Porath, Martina M.
AU - Scheepers, Hubertina C.
AU - Spaanderman, Marc E.
AU - Bloemenkamp, Kitty W.
AU - Van Lith, Jan M.
AU - Bolte, Antoinette C.
AU - Bax, Caroline J.
AU - Cornette, Jérôme
AU - Duvekot, Johannes J.
AU - Nij Bijvank, Sebastiaan W.
AU - Van Eyck, Jim
AU - Franssen, Maureen T.
AU - Sollie, Krystyna M.
AU - Woiski, Mallory
AU - Vandenbussche, Frank P.
AU - Van Der Post, Joris A.
AU - Bossuyt, Patrick M.
AU - Opmeer, Brent C.
AU - Mol, Ben W.
PY - 2015/4/1
Y1 - 2015/4/1
N2 - 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 membranes, cervical length between 10 and 30mm, 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.
AB - 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 membranes, cervical length between 10 and 30mm, 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.
KW - cervical length
KW - fetal fibronectin
KW - nifedipine
KW - preterm labor
KW - tocolysis
UR - http://www.scopus.com/inward/record.url?scp=84927605934&partnerID=8YFLogxK
U2 - 10.1055/s-0034-1390346
DO - 10.1055/s-0034-1390346
M3 - Article
C2 - 25486290
AN - SCOPUS:84927605934
VL - 32
SP - 451
EP - 459
JO - American journal of perinatology
JF - American journal of perinatology
SN - 0735-1631
IS - 5
ER -