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
Y1 - 2015
N2 - To evaluate whether tocolysis with nifedipine can be omitted in women with symptoms of preterm labor, a shortened cervix, and negative fetal fibronectin test. 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 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. 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. In symptomatic women with preterm labor, a shortened cervix, and negative fibronectin test, placebo treatment is not inferior to tocolysis with nifedipine
AB - To evaluate whether tocolysis with nifedipine can be omitted in women with symptoms of preterm labor, a shortened cervix, and negative fetal fibronectin test. 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 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. 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. In symptomatic women with preterm labor, a shortened cervix, and negative fibronectin test, placebo treatment is not inferior to tocolysis with nifedipine
U2 - https://doi.org/10.1055/s-0034-1390346
DO - https://doi.org/10.1055/s-0034-1390346
M3 - Article
C2 - 25486290
SN - 0735-1631
VL - 32
SP - 451
EP - 460
JO - American Journal of Perinatology
JF - American Journal of Perinatology
IS - 5
ER -