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Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes (Intra-O)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04043299
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Swedish International Development Cooperation Agency (SIDA)
Information provided by (Responsible Party):
Makerere University

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.


Condition or disease Intervention/treatment Phase
Fetal Distress Birth Asphyxia Drug: 100% Oxygen Drug: 21% oxygen Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention group will receive 100% medical oxygen while the control group will receive medical air
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Similar gas tanks will be used for both the intervention and control group
Primary Purpose: Supportive Care
Official Title: Birth Asphyxia in Uganda: Prevalence, Associated Factors and Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Intervention
This arm will receive 100% oxygen at a rate of 10L/min for 15 minutes
Drug: 100% Oxygen
High flow cylinder oxygen will be administered to women with fetal distress during labor
Other Name: Medical oxygen

Active Comparator: Control
This arm will receive medical air (21% oxygen) at a rate of 10 L/min for 15 minutes
Drug: 21% oxygen
High flow cylinder packaged medical air will be administered to women with fetal distress during labr
Other Name: Medical air




Primary Outcome Measures :
  1. Normalization of the fetal heart rate [ Time Frame: 30 minutes ]
    The fetal heart rate will be between 120 to 160 beats per minute


Secondary Outcome Measures :
  1. Birth Asphyxia [ Time Frame: At 5 minutes after birth ]
    Five minute Apgar score of less than 7 at 5 minutes. Apgar Score refers to Appearance, pulse, grimace, activity and respiration. Each of these 5 elements are scored from 0-2 where by 0 is the worst score meaning absence of the parameter while 2 is the best score. A total of 0 means that the newborn has no signs of life, 1-6 refers to an infant with asphyxia while infants with scores of 7 to 10 are considered normal.

  2. Hypoxic Ischemic encephalopathy [ Time Frame: 24 hours and 7 days after birth ]
    Hypoxic ischemic encephalopathy defined by Thompson Scores of 15 or more. This score is made of 9 signs assessed on a scale of 0-3. These are tone, level of consciousness, fits, posture, moro reflex, grasp reflex, suck, respiration and fontanel. Tone, level of consiciousness and posture are scored on a scale of 0-3 while the rest are scored on a scale of 0-2. A score of 0 for each individual item means normal while 2 or 3 refers to more severe problems. The lower the score, the better for a newborn.The maximum total score is 22 and scores of less than 10 are considered normal. However in this study, we shall consider scores of 15 or more as hypoxic ischemic encephalopathy.

  3. Neonatal Acidosis [ Time Frame: Within 5 minutes of birth ]
    Neonatal acidosis defined by cord artery lactate of more than 5.5mmol/l taken after delivery

  4. Status of newborn [ Time Frame: 7 days after birth ]
    Status of newborn indicating whether baby is alive or dead



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043299


Contacts
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Contact: Elizabeth Ayebare, MN +256(0)704878874 lizayeby@gmail.com
Contact: Grace Ndeezi, PhD +256(0)772453191 gndeezi@gmail.com

Locations
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Uganda
Kawempe National Referral Hospital Recruiting
Kampala, Uganda, 256
Contact: Elizabeth Ayebare, MN    0704878874    lizayeby@gmail.com   
Contact: Grace Ndeezi, PhD    0772453191    gndeezi@gmail.com   
Principal Investigator: Elizabeth Ayebare, MN         
Sub-Investigator: Jolly Nankunda, PhD         
Sponsors and Collaborators
Makerere University
Swedish International Development Cooperation Agency (SIDA)
Investigators
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Study Director: James K Tumwine, PhD Makerere University
Publications:
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.

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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT04043299    
Other Study ID Numbers: SHSREC 2017-051
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data may be shared with other researchers on request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Makerere University:
Intrapartum oxygen administration
first stage of labour
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Fetal Distress
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases