title: Randomized comparison of nifedipine and placebo in fibronectin-negative women with symptoms of preterm labor and a short cervix (APOSTEL-I Trial).
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.
  
  
  METHODS
  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.
  
  
  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.
  
  
  CONCLUSIONS
  In symptomatic women with preterm labor, a shortened cervix, and negative fibronectin test, placebo treatment is not inferior to tocolysis with nifedipine.
authors.affiliation: Department of Clinical Chemistry and Haematology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Jolande Y
authors.initials: JY
authors.lastname: Vis
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Gert-Jan
authors.initials: GJ
authors.lastname: van Baaren
authors.affiliation: Department of Obstetrics and Gynaecology, Máxima Medical Center, Veldhoven, The Netherlands.
authors.forename: Femke F
authors.initials: FF
authors.lastname: Wilms
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Martijn A
authors.initials: MA
authors.lastname: Oudijk
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Anneke
authors.initials: A
authors.lastname: Kwee
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Maastricht, Maastricht, The Netherlands.
authors.forename: Martina M
authors.initials: MM
authors.lastname: Porath
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Maastricht, Maastricht, The Netherlands.
authors.forename: Hubertina C
authors.initials: HC
authors.lastname: Scheepers
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Maastricht, Maastricht, The Netherlands.
authors.forename: Marc E
authors.initials: ME
authors.lastname: Spaanderman
authors.affiliation: Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Kitty W
authors.initials: KW
authors.lastname: Bloemenkamp
authors.affiliation: Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Jan M
authors.initials: JM
authors.lastname: van Lith
authors.affiliation: Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Antoinette C
authors.initials: AC
authors.lastname: Bolte
authors.affiliation: Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Caroline J
authors.initials: CJ
authors.lastname: Bax
authors.affiliation: Department of Obstetrics and Gynaecology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Cornette
authors.affiliation: Department of Obstetrics and Gynaecology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: Duvekot
authors.affiliation: Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, The Netherlands.
authors.forename: Sebastiaan W
authors.initials: SW
authors.lastname: Nij Bijvank
authors.affiliation: Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, The Netherlands.
authors.forename: Jim
authors.initials: J
authors.lastname: van Eyck
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Maureen T
authors.initials: MT
authors.lastname: Franssen
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Krystyna M
authors.initials: KM
authors.lastname: Sollie
authors.affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
authors.forename: Mallory
authors.initials: M
authors.lastname: Woiski
authors.affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
authors.forename: Frank P
authors.initials: FP
authors.lastname: Vandenbussche
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Joris A
authors.initials: JA
authors.lastname: van der Post
authors.affiliation: Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Bossuyt
authors.affiliation: Clinical Research Unit, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Brent C
authors.initials: BC
authors.lastname: Opmeer
authors.affiliation: School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
authors.forename: Ben W
authors.initials: BW
authors.lastname: Mol
mesh_terms: D000328:Adult; D054791:Cervical Length Measurement; D005260:Female; D005353:Fibronectins / Q000032:analysis*; D005865:Gestational Age; D006801:Humans; D009426:Netherlands; D009543:Nifedipine / Q000627:therapeutic use*; D007752:Obstetric Labor, Premature / Q000188:drug therapy* / Q000517:prevention & control; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000517:prevention & control; D015149:Tocolytic Agents / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005353:Fibronectins; D015149:Tocolytic Agents; D009543:Nifedipine