Birth Asphyxia Clinical Trial
— Intra-OOfficial title:
Birth Asphyxia in Uganda: Prevalence, Associated Factors and Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes
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.
Status | Recruiting |
Enrollment | 1108 |
Est. completion date | October 30, 2020 |
Est. primary completion date | August 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Uganda | Kawempe National Referral Hospital | Kampala |
Lead Sponsor | Collaborator |
---|---|
Makerere University | Swedish International Development Cooperation Agency (SIDA) |
Uganda,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normalization of the fetal heart rate | The fetal heart rate will be between 120 to 160 beats per minute | 30 minutes | |
Secondary | Birth Asphyxia | 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. | At 5 minutes after birth | |
Secondary | Hypoxic Ischemic encephalopathy | 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. | 24 hours and 7 days after birth | |
Secondary | Neonatal Acidosis | Neonatal acidosis defined by cord artery lactate of more than 5.5mmol/l taken after delivery | Within 5 minutes of birth | |
Secondary | Status of newborn | Status of newborn indicating whether baby is alive or dead | 7 days after birth |
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