Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes

Summary

Introduction Birth asphyxia is one of leading causes of neonatal mortality in Uganda. It is associated with long term neuro-developmental complications among the babies that survive. Preventive measures for birth asphyxia intrauterine are not clearly understood and thus the need for this study. The aim of the study is to assess the effect of intrapartum oxygen administration on fetal and early neonatal outcomes. Methods A double-blind randomized clinical trial which will be conducted in Gulu regional referral and Kawempe National referral hospitals in Uganda. A total sample size of 1108 women in labour will be enrolled with 554 participants per group. The intervention will include administration of 10 L/min of 100% oxygen for 15 minutes to women in established labor who have signs of fetal distress with fetal heart rate of less than 120 or above 160 beats per minute. The control group will receive medical air (21% oxygen) using the same criteria. Women and babies will be followed up until 7 days after birth to document the outcomes. Statistical analysis to identify difference in outcomes between the control and intervention groups will be performed. Ethical considerations Ethical approval and permission was received from relevant research and ethics committees. Informed consent will be sought from the participants. A data and safety monitoring board will be set up to review periodically the progress of the clinical trial study. Participants will be monitored for adverse events and severe adverse events; reporting will be done according to the research and ethics committee guidelines.

Timeline

Start

2020-03-16

Primary completion

2020-08-30

Completion

2020-10-30

Publications

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• Background Simpson KR. Intrauterine resuscitation during labor: review of current methods and supportive evidence. J Midwifery Womens Health. 2007 May-Jun;52(3):229-37. doi: 10.1016/j.jmwh.2006.12.010.
• Background Bullens LM, Moors S, van Runnard Heimel PJ, van der Hout-van der Jagt MB, Oei SG. Practice variation in the management of intrapartum fetal distress in The Netherlands and the Western world. Eur J Obstet Gynecol Reprod Biol. 2016 Oct;205:48-53. doi: 10.1016/j.ejogrb.2016.08.012. Epub 2016 Aug 16.
• Background Adanikin AI, Awoleke JO. Clinical suspicion, management and outcome of intrapartum foetal distress in a public hospital with limited advanced foetal surveillance. J Matern Fetal Neonatal Med. 2017 Feb;30(4):424-429. doi: 10.1080/14767058.2016.1174991. Epub 2016 Apr 25.
• Background Fawole B, Hofmeyr GJ. Maternal oxygen administration for fetal distress. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD000136. doi: 10.1002/14651858.CD000136.pub2.
• Background Weeke LC, Vilan A, Toet MC, van Haastert IC, de Vries LS, Groenendaal F. A Comparison of the Thompson Encephalopathy Score and Amplitude-Integrated Electroencephalography in Infants with Perinatal Asphyxia and Therapeutic Hypothermia. Neonatology. 2017;112(1):24-29. doi: 10.1159/000455819. Epub 2017 Feb 17.
• Background Vernon G, Alfirevic Z, Weeks A. Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258]. Trials. 2006 May 11;7:13. doi: 10.1186/1745-6215-7-13.
• Background Lawton J, Snowdon C, Morrow S, Norman JE, Denison FC, Hallowell N. Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals. Trials. 2016 Apr 11;17:195. doi: 10.1186/s13063-016-1323-3.
• Background Pildner von Steinburg S, Boulesteix AL, Lederer C, Grunow S, Schiermeier S, Hatzmann W, Schneider KT, Daumer M. What is the "normal" fetal heart rate? PeerJ. 2013 Jun 4;1:e82. doi: 10.7717/peerj.82. Print 2013.
• Background Siriussawakul A, Triyasunant N, Nimmannit A, Ngerncham S, Hirunkanokpan P, Luang-Aram S, Pechpaisit N, Wangdee A, Ruangvutilert P. Effects of supplemental oxygen on maternal and neonatal oxygenation in elective cesarean section under spinal anesthesia: a randomized controlled trial. Biomed Res Int. 2014;2014:627028. doi: 10.1155/2014/627028. Epub 2014 Feb 20.
• Background Thorp JA, Trobough T, Evans R, Hedrick J, Yeast JD. The effect of maternal oxygen administration during the second stage of labor on umbilical cord blood gas values: a randomized controlled prospective trial. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):465-74. doi: 10.1016/0002-9378(95)90558-8.
• Background Dawood MA, Al-Arnous MA. The Effect of Maternal Oxygen Adminstration During The Second Stage of Normal Vaginal Delivery Or During Cesarean Section Under General Anaesthesia On Umblical Cord Blood Gases and Acid-Base State. Alexandria Journal of Pediatrics. 2002;16(2):233.
• Background Casey BM, McIntire DD, Leveno KJ. The continuing value of the Apgar score for the assessment of newborn infants. N Engl J Med. 2001 Feb 15;344(7):467-71. doi: 10.1056/NEJM200102153440701.
• Background Morales P, Bustamante D, Espina-Marchant P, Neira-Pena T, Gutierrez-Hernandez MA, Allende-Castro C, Rojas-Mancilla E. Pathophysiology of perinatal asphyxia: can we predict and improve individual outcomes? EPMA J. 2011 Jun;2(2):211-30. doi: 10.1007/s13167-011-0100-3. Epub 2011 Jul 26.

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