Tags

Type your tag names separated by a space and hit enter

Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial).
BMC Pregnancy Childbirth. 2009 Sep 09; 9:42.BP

Abstract

BACKGROUND

Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours.

METHODS/DESIGN

The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, beta 0.2 at alpha 0.05).

DISCUSSION

This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks.

CLINICAL TRIAL REGISTRATION

http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. C.Roos@obgyn.umcn.nlNo 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 availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19737426

Citation

Roos, Carolien, et al. "Assessment of Perinatal Outcome After Sustained Tocolysis in Early Labour (APOSTEL-II Trial)." BMC Pregnancy and Childbirth, vol. 9, 2009, p. 42.
Roos C, Scheepers LH, Bloemenkamp KW, et al. Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial). BMC Pregnancy Childbirth. 2009;9:42.
Roos, C., Scheepers, L. H., Bloemenkamp, K. W., Bolte, A., Cornette, J., Derks, J. B., Duvekot, H. J., van Eyck, J., Kok, J. H., Kwee, A., Merién, A., Opmeer, B. C., van Pampus, M. G., Papatsonis, D. N., Porath, M. M., van der Post, J. A., Scherjon, S. A., Sollie, K., Spaanderman, M. E., ... Lotgering, F. K. (2009). Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial). BMC Pregnancy and Childbirth, 9, 42. https://doi.org/10.1186/1471-2393-9-42
Roos C, et al. Assessment of Perinatal Outcome After Sustained Tocolysis in Early Labour (APOSTEL-II Trial). BMC Pregnancy Childbirth. 2009 Sep 9;9:42. PubMed PMID: 19737426.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial). AU - Roos,Carolien, AU - Scheepers,Liesbeth Hcj, AU - Bloemenkamp,Kitty Wm, AU - Bolte,Annemiek, AU - Cornette,Jerome, AU - Derks,Jan B, AU - Duvekot,Hans Jj, AU - van Eyck,Jim, AU - Kok,Joke H, AU - Kwee,Anneke, AU - Merién,Ashley, AU - Opmeer,Brent C, AU - van Pampus,Mariëlle G, AU - Papatsonis,Dimitri Nm, AU - Porath,Martina M, AU - van der Post,Joris Am, AU - Scherjon,Sicco A, AU - Sollie,Krystyne, AU - Spaanderman,Marc Ea, AU - Vijgen,Sylvia Mc, AU - Willekes,Christine, AU - Mol,Ben Willem J, AU - Lotgering,Fred K, Y1 - 2009/09/09/ PY - 2009/06/29/received PY - 2009/09/09/accepted PY - 2009/9/10/entrez PY - 2009/9/10/pubmed PY - 2010/2/26/medline SP - 42 EP - 42 JF - BMC pregnancy and childbirth JO - BMC Pregnancy Childbirth VL - 9 N2 - BACKGROUND: Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. METHODS/DESIGN: The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, beta 0.2 at alpha 0.05). DISCUSSION: This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. CLINICAL TRIAL REGISTRATION: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008. SN - 1471-2393 UR - https://www.unboundmedicine.com/medline/citation/19737426/Assessment_of_perinatal_outcome_after_sustained_tocolysis_in_early_labour__APOSTEL_II_trial__ L2 - https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/1471-2393-9-42 DB - PRIME DP - Unbound Medicine ER -