Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor APOSTEL-II trial Dutch trial register: NTR 1336 Carolien Roos, MD, PhD student, UMC St Radboud Dutch APOSTEL-II Collaborative Trial Group Marc EA Spaanderman, Liesbeth HCJ Scheepers, Kitty WM Bloemenkamp, Annemiek Bolte, Jerome J Cornette, Johannes J Duvekot, Jim van Eyck, Joke H Kok, Anneke Kwee, Ashley Merién, Brent C Opmeer, Martijn A Oudijk, Mariëlle G van Pampus, Dimitri NM Papatsonis, Martina M Porath, Sicco A Scherjon, Ewoud Schuit, Krystyne Sollie, Sylvia MC Vijgen, Christine Willekes, Ben WJ Mol, Joris AM van der Post, Fred K Lotgering
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Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor APOSTEL-II trial
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Assessment of Perinatal Outcomewith Sustained Tocolysis
in Early Labor
APOSTEL-II trialDutch trial register: NTR 1336
Carolien Roos, MD, PhD student, UMC St Radboud
Dutch APOSTEL-II Collaborative Trial Group
Marc EA Spaanderman, Liesbeth HCJ Scheepers, Kitty WM Bloemenkamp, Annemiek Bolte, Jerome J Cornette, Johannes J Duvekot, Jim van
Eyck, Joke H Kok, Anneke Kwee, Ashley Merién, Brent C Opmeer, Martijn A Oudijk, Mariëlle G van Pampus, Dimitri NM Papatsonis, Martina M Porath, Sicco A Scherjon, Ewoud Schuit, Krystyne Sollie, Sylvia MC Vijgen, Christine Willekes,
Ben WJ Mol, Joris AM van der Post, Fred K Lotgering
1 Ananth et al. Epidemiology of preterm birth and its clinical subtypes. J Matern Fetal Neonatal Med 20062 Gilbert et al. The cost of prematurity: quantification by gestational age and birth weight. Obstet Gynecol 2003 3 Gaunekar NN, et al. Maintenance therapy with calcium channel blockers for preventing preterm birth after threatened preterm labour. Cochrane Database Syst Rev 2004; CD 004071
Hypothesis
Sustained tocolysis with
nifedipine
reduces perinatal mortality and
severe perinatal morbidity
Inclusion criteria
Diagnosis of threatened preterm
labor
Gestational age: 26 to 32+2 weeks
Corticosteroids and tocolytic
treatment for 48 hours
Exclusion criteria
Pre-eclampsia or HELLP syndrome
Intrauterine infection / fetal
distress
Lethal congenital anomalies
Maternal hypertension
Placenta previa
Intervention
12 days sustained tocolysis:
Nifedipine 4 dd 20 mg orally
Placebo
Randomization
Nifedipine 4dd 20 mg orally
Placebo
t=-2 t=0 t=12
48 hrs tocolysis &
corticosteroids
Methods
Primary outcome
Composite adverse perinatal outcome
Perinatal death Chronic lung disease Intraventricular hemorrhage > grade II Periventricular leucomalacia > grade I Necrotizing enterocolitis Proven neonatal sepsis
Secondary outcomes
Gestational age at delivery Birth weight Ventilation support (days) NICU admission (days) Hospital admission (days)
Statistics
To detect a reduction of 11% in
adverse perinatal outcome,
we needed to enroll 406 patients
Intention-to-treat analysis
RR and HR; 95% CI
Kaplan-Meier curve
Eligible (n=636)
Non-randomization (n=230)
Nifedipine (n=201)
Placebo (n=205)
Allocation
Analysis
Randomized (n=406)
Exclusion
Analyzed (n=205)
Analyzed (n=201)
Baseline characteristics at randomizationRandomization
n=406Non-
randomization n=230
Nifedipinen=201
Placebon=205
Age – yrs 30.2 ± 5.1 30.2 ± 5.1
Body Mass Index # 23.3 ± 4.7 23.2 ± 4.0
Caucasian – no. (%) 166 (83) 155 (76)
Nulliparous – no.(%) 116 (58) 106 (52)
Previous preterm birth – no. (%)
39 (19) 55 (27)
Gestational age – wks 29.2 ± 1.7 29.2 ± 1.7
Multifetal gestation – no. (%)
42 (21) 48 (23)
PPROM – no. (%) 53 (26) 48 (23)
Vaginal bleeding – no. (%) 38 (19) 38 (19)
Vaginal examinationDilatation (cm)
n=1340 (0 – 1)
n=1321 (0 – 2)
Cervical length (mm) 26 (15 - 35) 23 (15 - 30)
# kg/m2Data are presented as mean ± SD or median (IQR: 25th to 75th percentile)
Baseline characteristics at randomizationRandomization
n=406Non-
randomization n=230
Nifedipinen=201
Placebon=205
Age – yrs 30.2 ± 5.1 30.2 ± 5.1 28.7 ± 5.5
Body Mass Index # 23.3 ± 4.7 23.2 ± 4.0 23.5 ± 5.0