Trial · NCT04043299
Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes
NCT04043299, Phase 3, Unknown, Makerere University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes. Trials, record NCT04043299. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04043299
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes
- NCT number
- NCT04043299
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 1,108 participants, estimated
- Lead sponsor
- Makerere University
- Conditions
- Fetal Distress, Birth Asphyxia
- Interventions
- 100% Oxygen, 21% oxygen
- First posted
- 2019-08-02
- Last updated
- 2020-03-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Normalization of the fetal heart rate | 30 minutes | The fetal heart rate will be between 120 to 160 beats per minute |
| Secondary | Birth Asphyxia | 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. |
| Secondary | Hypoxic Ischemic encephalopathy | 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. |
| Secondary | Neonatal Acidosis | Within 5 minutes of birth | Neonatal acidosis defined by cord artery lactate of more than 5.5mmol/l taken after delivery |
| Secondary | Status of newborn | 7 days after birth | Status of newborn indicating whether baby is alive or dead |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04043299
GET https://conductscience.org/api/trials/v1/NCT04043299/registered