Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes

NCT04043299 | Unknown Phase 3 DMC

• 1 other identifier: SHSREC 2017-051
• Study Type: interventional
• Target: 1,108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Distress; Birth Asphyxia

Keywords

Intrapartum oxygen administration; first stage of labour

Outcome Measures

Primary Outcomes (1)

• Normalization of the fetal heart rate

  The fetal heart rate will be between 120 to 160 beats per minute

  30 minutes

Secondary Outcomes (4)

• Birth Asphyxia

  At 5 minutes after birth

• Hypoxic Ischemic encephalopathy

  24 hours and 7 days after birth

• Neonatal Acidosis

  Within 5 minutes of birth

• Status of newborn

  7 days after birth

Study Arms (2)

Intervention

EXPERIMENTAL

This arm will receive 100% oxygen at a rate of 10L/min for 15 minutes

Drug: 100% Oxygen

Control

ACTIVE COMPARATOR

This arm will receive medical air (21% oxygen) at a rate of 10 L/min for 15 minutes

Drug: 21% oxygen

Interventions

100% Oxygen DRUG

High flow cylinder oxygen will be administered to women with fetal distress during labor

Also known as: Medical oxygen

Intervention

21% oxygen DRUG

High flow cylinder packaged medical air will be administered to women with fetal distress during labr

Also known as: Medical air

Control

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women in active first stage of labor who develop fetal distress will be included

You may not qualify if:

• Women in labor with critical conditions such as eclampsia, chronic heart disease, chronic lung disease and chronic renal failure
• Women in preterm labor
• Those taking Bleomycin and Amiodarone medications

Sponsors & Collaborators

• Makerere University: lead
• Swedish International Development Cooperation Agency (SIDA): collaborator

Study Sites (1)

Kawempe National Referral Hospital

Kampala, 256, Uganda

RECRUITING

Related Publications (14)

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  PMID: 21278499 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.

  PMID: 17467589 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.

  PMID: 27566222 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.

  PMID: 27050656 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.

  PMID: 23235574 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.

  PMID: 28208138 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.

  PMID: 16689989 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.

  PMID: 27066777 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.

  PMID: 23761161 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.

  PMID: 24696860 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.

  PMID: 7856671 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.

  PMID: 11172187 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.

  PMID: 23199150 BACKGROUND

MeSH Terms

Conditions

Fetal Distress; Asphyxia Neonatorum

Interventions

Oxygen; Air

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• James K Tumwine, PhD

  Makerere University

  STUDY DIRECTOR

Central Study Contacts

Elizabeth Ayebare, MN

CONTACT

+256(0)704878874; lizayeby@gmail.com

Grace Ndeezi, PhD

CONTACT

+256(0)772453191; gndeezi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Similar gas tanks will be used for both the intervention and control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group will receive 100% medical oxygen while the control group will receive medical air

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: March 16, 2020
• Primary Completion: August 30, 2020
• Study Completion: October 30, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)