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Nifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial).
BMC Pregnancy Childbirth. 2014 Mar 03; 14:93.BP

Abstract

BACKGROUND

Preterm birth is the most common cause of neonatal morbidity and mortality. Postponing delivery for 48 hours with tocolytics to allow for maternal steroid administration and antenatal transportation to a centre with neonatal intensive care unit facilities is the standard treatment for women with threatening preterm delivery in most centres. However, there is controversy as to which tocolytic agent is the drug of first choice. Previous trials have focused on tocolytic efficacy and side effects, and are probably underpowered to detect clinically meaningfull differences in neonatal outcome. Thus, the current evidence is inconclusive to support a balanced recommendation for clinical practice. This multicenter randomised clinical trial aims to compare nifedipine and atosiban in terms of neonatal outcome, duration of pregnancy and maternal side effects.

METHODS/DESIGN

The Apostel III trial is a nationwide multicenter randomised controlled study. Women with threatened preterm labour (gestational age 25 - 34 weeks) defined as at least 3 contractions per 30 minutes, and 1) a cervical length of ≤ 10 mm or 2) a cervical length of 11-30 mm and a positive Fibronectin test or 3) ruptured membranes will be randomly allocated to treatment with nifedipine or atosiban. Primary outcome is a composite measure of severe neonatal morbidity and mortality. Secondary outcomes will be time to delivery, gestational age at delivery, days on ventilation support, neonatal intensive care (NICU) admittance, length admission in neonatal intensive care, total days in hospital until 3 months corrected age, convulsions, apnoea, asphyxia, proven meningitis, pneumothorax, maternal side effects and costs. Furthermore, an economic evaluation of the treatment will be performed. Analysis will be by intention to treat principle. The power calculation is based on an expected 10% difference in the prevalence of adverse neonatal outcome. This implies that 500 women have to be randomised (two sided test, β 0.2 at alpha 0.05).

DISCUSSION

This trial will provide evidence on the optimal drug of choice in acute tocolysis in threatening preterm labour.

CLINICAL TRIAL REGISTRATION

NTR2947, date of registration: June 20th 2011.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands. e.o.g.vanvliet@umcutrecht.nl.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24589124

Citation

van Vliet, Elvira Og, et al. "Nifedipine Versus Atosiban in the Treatment of Threatened Preterm Labour (Assessment of Perinatal Outcome After Specific Tocolysis in Early Labour: APOSTEL III-Trial)." BMC Pregnancy and Childbirth, vol. 14, 2014, p. 93.
van Vliet EO, Schuit E, Heida KY, et al. Nifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial). BMC Pregnancy Childbirth. 2014;14:93.
van Vliet, E. O., Schuit, E., Heida, K. Y., Opmeer, B. C., Kok, M., Gyselaers, W., Porath, M. M., Woiski, M., Bax, C. J., Bloemenkamp, K. W., Scheepers, H. C., Jaquemyn, Y., van Beek, E., Duvekot, H. J., Franssen, M. T., Bijvank, B. N., Kok, J. H., Franx, A., Mol, B. W., & Oudijk, M. A. (2014). Nifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial). BMC Pregnancy and Childbirth, 14, 93. https://doi.org/10.1186/1471-2393-14-93
van Vliet EO, et al. Nifedipine Versus Atosiban in the Treatment of Threatened Preterm Labour (Assessment of Perinatal Outcome After Specific Tocolysis in Early Labour: APOSTEL III-Trial). BMC Pregnancy Childbirth. 2014 Mar 3;14:93. PubMed PMID: 24589124.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial). AU - van Vliet,Elvira Og, AU - Schuit,Ewoud, AU - Heida,Karst Y, AU - Opmeer,Brent C, AU - Kok,Marjolein, AU - Gyselaers,Wilfried, AU - Porath,Martina M, AU - Woiski,Mallory, AU - Bax,Caroline J, AU - Bloemenkamp,Kitty Wm, AU - Scheepers,Hubertina Cj, AU - Jaquemyn,Yves, AU - van Beek,Erik, AU - Duvekot,Hans Jj, AU - Franssen,Maureen Tm, AU - Bijvank,Bas N, AU - Kok,Joke H, AU - Franx,Arie, AU - Mol,Ben Willem J, AU - Oudijk,Martijn A, Y1 - 2014/03/03/ PY - 2014/01/29/received PY - 2014/02/27/accepted PY - 2014/3/5/entrez PY - 2014/3/5/pubmed PY - 2014/11/5/medline SP - 93 EP - 93 JF - BMC pregnancy and childbirth JO - BMC Pregnancy Childbirth VL - 14 N2 - BACKGROUND: Preterm birth is the most common cause of neonatal morbidity and mortality. Postponing delivery for 48 hours with tocolytics to allow for maternal steroid administration and antenatal transportation to a centre with neonatal intensive care unit facilities is the standard treatment for women with threatening preterm delivery in most centres. However, there is controversy as to which tocolytic agent is the drug of first choice. Previous trials have focused on tocolytic efficacy and side effects, and are probably underpowered to detect clinically meaningfull differences in neonatal outcome. Thus, the current evidence is inconclusive to support a balanced recommendation for clinical practice. This multicenter randomised clinical trial aims to compare nifedipine and atosiban in terms of neonatal outcome, duration of pregnancy and maternal side effects. METHODS/DESIGN: The Apostel III trial is a nationwide multicenter randomised controlled study. Women with threatened preterm labour (gestational age 25 - 34 weeks) defined as at least 3 contractions per 30 minutes, and 1) a cervical length of ≤ 10 mm or 2) a cervical length of 11-30 mm and a positive Fibronectin test or 3) ruptured membranes will be randomly allocated to treatment with nifedipine or atosiban. Primary outcome is a composite measure of severe neonatal morbidity and mortality. Secondary outcomes will be time to delivery, gestational age at delivery, days on ventilation support, neonatal intensive care (NICU) admittance, length admission in neonatal intensive care, total days in hospital until 3 months corrected age, convulsions, apnoea, asphyxia, proven meningitis, pneumothorax, maternal side effects and costs. Furthermore, an economic evaluation of the treatment will be performed. Analysis will be by intention to treat principle. The power calculation is based on an expected 10% difference in the prevalence of adverse neonatal outcome. This implies that 500 women have to be randomised (two sided test, β 0.2 at alpha 0.05). DISCUSSION: This trial will provide evidence on the optimal drug of choice in acute tocolysis in threatening preterm labour. CLINICAL TRIAL REGISTRATION: NTR2947, date of registration: June 20th 2011. SN - 1471-2393 UR - https://www.unboundmedicine.com/medline/citation/24589124/Nifedipine_versus_atosiban_in_the_treatment_of_threatened_preterm_labour__Assessment_of_Perinatal_Outcome_after_Specific_Tocolysis_in_Early_Labour:_APOSTEL_III_Trial__ L2 - https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/1471-2393-14-93 DB - PRIME DP - Unbound Medicine ER -