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

Trials

Rohan Joshi¹  Edwin R. van den Heuvel²  S. Guid Oei³  Alexandra D. J. Hulsenboom³  Lauren M. Bullens³  M. Beatrijs van der Hout-van der Jagt³  Pieter J. van Runnard Heimel³  Suzanne Moors³ 

[1]Department of Clinical Physics, Máxima Medical Centre

[2]Department of Mathematics and Computer Science, Eindhoven University of Technology

[3]Department of Obstetrics and Gynaecology, Máxima Medical Centre

关键词: Foetal distress;    Foetal heart rate;    Cardiotocogram;    Intrauterine resuscitation;    Maternal hyperoxygenation;    Neonatal outcome;   

DOI  :  10.1186/s13063-018-2567-x

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown