Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial.
OBJECTIVE
To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant.


METHODS
Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo.


METHODS
Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire.


METHODS
Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry.


RESULTS
Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29-9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04).


CONCLUSIONS
This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time.


CONCLUSIONS
No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome.
Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands.
Eog
E
van Vliet
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
L
L
Seinen
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
C
C
Roos
Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.|Stanford Prevention Research Centre, Department of Medicine, Stanford University, Stanford, CA, USA.
E
E
Schuit
Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands.
Hcj
H
Scheepers
Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands.
Kwm
K
Bloemenkamp
Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands.
J J
JJ
Duvekot
Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, the Netherlands.
J
J
van Eyck
Department of Neonatology, Academic Medical Centre, Amsterdam, the Netherlands.
J H
JH
Kok
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
F K
FK
Lotgering
Utrecht Centre for Child and Adolescent Studies, Utrecht University, Utrecht, the Netherlands.
A
A
van Baar
Department of Neonatology, Academic Medical Centre, Amsterdam, the Netherlands.
A G
AG
van Wassenaer-Leemhuis
Department of Obstetrics, University Medical Centre, University of Groningen, Groningen, the Netherlands.
M T
MT
Franssen
Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands.
M M
MM
Porath
Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands.
Jam
J
van der Post
Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands.
A
A
Franx
The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia.
Bwj
B
Mol
Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands.|Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands.
M A
MA
Oudijk
D000328:Adult; D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000517:prevention & control; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D065886:Neurodevelopmental Disorders / Q000139:chemically induced*; D009543:Nifedipine / Q000627:therapeutic use*; D007752:Obstetric Labor, Premature / Q000517:prevention & control*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D011263:Pregnancy Trimester, Third; D011297:Prenatal Exposure Delayed Effects; D015145:Tocolysis / Q000379:methods; D015149:Tocolytic Agents / Q000627:therapeutic use*
D015149:Tocolytic Agents; D009543:Nifedipine
Maintenance tocolysis; nifedipine; outcome; preterm birth