Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)

BACKGROUND: Perinatal asphyxia is, even in developed countries, one the major causes of neonatal morbidity and mortality. Therefore, if foetal distress during labour is suspected, one should try to restore foetal oxygen levels or aim for immediate delivery. However, studies on the effect of intraute...

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Autores principales: Bullens, Lauren M., Hulsenboom, Alexandra D. J., Moors, Suzanne, Joshi, Rohan, van Runnard Heimel, Pieter J., van der Hout-van der Jagt, M. Beatrijs, van den Heuvel, Edwin R., Guid Oei, S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Study Protocol
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5865381/
https://www.ncbi.nlm.nih.gov/pubmed/29566729
http://dx.doi.org/10.1186/s13063-018-2567-x
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author Bullens, Lauren M.
Hulsenboom, Alexandra D. J.
Moors, Suzanne
Joshi, Rohan
van Runnard Heimel, Pieter J.
van der Hout-van der Jagt, M. Beatrijs
van den Heuvel, Edwin R.
Guid Oei, S.
author_facet Bullens, Lauren M.
Hulsenboom, Alexandra D. J.
Moors, Suzanne
Joshi, Rohan
van Runnard Heimel, Pieter J.
van der Hout-van der Jagt, M. Beatrijs
van den Heuvel, Edwin R.
Guid Oei, S.
author_sort Bullens, Lauren M.
collection PubMed
description BACKGROUND: Perinatal asphyxia is, even in developed countries, one the major causes of neonatal morbidity and mortality. Therefore, if foetal distress during labour is suspected, one should try to restore foetal oxygen levels or aim for immediate delivery. However, studies on the effect of intrauterine resuscitation during labour are scarce. We designed a randomised controlled trial to investigate the effect of maternal hyperoxygenation on the foetal condition. In this study, maternal hyperoxygenation is induced for the treatment of foetal distress during the second stage of term labour. METHODS/DESIGN: This study is a single-centre randomised controlled trial being performed in a tertiary hospital in The Netherlands. From among cases of a suboptimal or abnormal foetal heart rate pattern during the second stage of term labour, a total of 116 patients will be randomised to the control group, where normal care is provided, or to the intervention group, where before normal care 100% oxygen is supplied to the mother by a non-rebreathing mask until delivery. The primary outcome is change in foetal heart rate pattern. Secondary outcomes are Apgar score, mode of delivery, admission to the neonatal intensive care unit and maternal side effects. In addition, blood gas values and malondialdehyde are determined in umbilical cord blood. DISCUSSION: This study will be the first randomised controlled trial to investigate the effect of maternal hyperoxygenation for foetal distress during labour. This intervention should be recommended only as a treatment for intrapartum foetal distress, when improvement of the foetal condition is likely and outweighs maternal and neonatal side effects. TRIAL REGISTRATION: EudraCT, 2015-001654-15; registered on 3 April 2015. Dutch Trial Register, NTR5461; registered on 20 October 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2567-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-58653812018-03-27 Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2) Bullens, Lauren M. Hulsenboom, Alexandra D. J. Moors, Suzanne Joshi, Rohan van Runnard Heimel, Pieter J. van der Hout-van der Jagt, M. Beatrijs van den Heuvel, Edwin R. Guid Oei, S. Trials Study Protocol BACKGROUND: Perinatal asphyxia is, even in developed countries, one the major causes of neonatal morbidity and mortality. Therefore, if foetal distress during labour is suspected, one should try to restore foetal oxygen levels or aim for immediate delivery. However, studies on the effect of intrauterine resuscitation during labour are scarce. We designed a randomised controlled trial to investigate the effect of maternal hyperoxygenation on the foetal condition. In this study, maternal hyperoxygenation is induced for the treatment of foetal distress during the second stage of term labour. METHODS/DESIGN: This study is a single-centre randomised controlled trial being performed in a tertiary hospital in The Netherlands. From among cases of a suboptimal or abnormal foetal heart rate pattern during the second stage of term labour, a total of 116 patients will be randomised to the control group, where normal care is provided, or to the intervention group, where before normal care 100% oxygen is supplied to the mother by a non-rebreathing mask until delivery. The primary outcome is change in foetal heart rate pattern. Secondary outcomes are Apgar score, mode of delivery, admission to the neonatal intensive care unit and maternal side effects. In addition, blood gas values and malondialdehyde are determined in umbilical cord blood. DISCUSSION: This study will be the first randomised controlled trial to investigate the effect of maternal hyperoxygenation for foetal distress during labour. This intervention should be recommended only as a treatment for intrapartum foetal distress, when improvement of the foetal condition is likely and outweighs maternal and neonatal side effects. TRIAL REGISTRATION: EudraCT, 2015-001654-15; registered on 3 April 2015. Dutch Trial Register, NTR5461; registered on 20 October 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2567-x) contains supplementary material, which is available to authorized users. BioMed Central 2018-03-23 /pmc/articles/PMC5865381/ /pubmed/29566729 http://dx.doi.org/10.1186/s13063-018-2567-x Text en © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Bullens, Lauren M.
Hulsenboom, Alexandra D. J.
Moors, Suzanne
Joshi, Rohan
van Runnard Heimel, Pieter J.
van der Hout-van der Jagt, M. Beatrijs
van den Heuvel, Edwin R.
Guid Oei, S.
Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)
title Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)
title_full Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)
title_fullStr Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)
title_full_unstemmed Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)
title_short Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)
title_sort intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (interest o2)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5865381/
https://www.ncbi.nlm.nih.gov/pubmed/29566729
http://dx.doi.org/10.1186/s13063-018-2567-x
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