Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes (Intra-O)
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|ClinicalTrials.gov Identifier: NCT04043299|
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : March 26, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1108 participants|
|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|
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
- Normalization of the fetal heart rate [ Time Frame: 30 minutes ]The fetal heart rate will be between 120 to 160 beats per minute
- 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.
- 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.
- 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
- Status of newborn [ Time Frame: 7 days after birth ]Status of newborn indicating whether baby is alive or dead
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
|Contact: Elizabeth Ayebare, MN||+256(0)firstname.lastname@example.org|
|Contact: Grace Ndeezi, PhD||+256(0)email@example.com|
|Kawempe National Referral Hospital||Recruiting|
|Kampala, Uganda, 256|
|Contact: Elizabeth Ayebare, MN 0704878874 firstname.lastname@example.org|
|Contact: Grace Ndeezi, PhD 0772453191 email@example.com|
|Principal Investigator: Elizabeth Ayebare, MN|
|Sub-Investigator: Jolly Nankunda, PhD|
|Study Director:||James K Tumwine, PhD||Makerere University|