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Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes

NCT04043299 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1108

Last updated 2020-03-26

No results posted yet for this study

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

Interventions

DRUG

100% Oxygen

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

DRUG

21% oxygen

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

Sponsors & Collaborators

  • Swedish International Development Cooperation Agency (SIDA)

    collaborator OTHER_GOV

  • Makerere University

    lead OTHER

Principal Investigators

  • James K Tumwine, PhD · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-16
Primary Completion
2020-08-30
Completion
2020-10-30

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04043299 on ClinicalTrials.gov