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Maternal Oxygen Supplementation for Fetal Distress (MOXY Trial)
N/A
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gestational age>=37 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 and 10 minutes of neonatal life
Awards & highlights
MOXY Trial Summary
This trial will measure safety and efficacy of supplemental oxygen for women in labor with Category II EFM.
Who is the study for?
This trial is for pregnant women at or beyond 37 weeks of gestation, in spontaneous labor or induction, who speak English or Spanish and are having single babies with planned continuous fetal monitoring. It excludes those scheduled for cesarean delivery, with the most severe fetal heart rate issues (Category III), major fetal anomalies, multiple pregnancies, maternal oxygen levels below 95%, or preterm gestation.Check my eligibility
What is being tested?
The study tests whether giving extra oxygen to mothers during labor when there's a concern about the baby's oxygen supply (Category II EFM) is safe and effective compared to just breathing room air. This large study will randomly assign participants to either receive supplemental oxygen or breathe normal air to see which is better.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally speaking, potential concerns could include effects on the mother's and baby’s respiratory systems due to increased oxygen levels. The trial aims to establish safety data for this common practice.
MOXY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pregnancy has reached or passed 37 weeks.
MOXY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of neonates meeting criteria for composite neonatal morbidity
Secondary outcome measures
Apgar<5 at 5 and 10 mins
Apgars at 5 and 10 minutes
Percentage of neonates with Neonatal Intensive care unit admission
+14 moreMOXY Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OxygenExperimental Treatment1 Intervention
Group II: Room airActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,297,571 Total Patients Enrolled
1 Trials studying Fetal Hypoxia
114 Patients Enrolled for Fetal Hypoxia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,670,673 Total Patients Enrolled
University of MichiganOTHER
1,798 Previous Clinical Trials
6,376,014 Total Patients Enrolled
1 Trials studying Fetal Hypoxia
23 Patients Enrolled for Fetal Hypoxia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were born prematurely.You are pregnant with only one baby.You are in the third category of fetal monitoring when you are admitted.The baby has a serious birth defect.The mother has low oxygen levels below 95%.My pregnancy has reached or passed 37 weeks.I speak English or Spanish.You are going into labor naturally or having labor induced.
Research Study Groups:
This trial has the following groups:- Group 1: Oxygen
- Group 2: Room air
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being accepted into this research project?
"Affirmative, clinicaltrials.gov conveys that this medical experiment is actively recruiting participants. It was initially listed on May 22nd 2023 and updated most recently on June 6th 2023; the study aims to recruit 2124 patients from a single site."
Answered by AI
Is the recruitment stage of this trial still open?
"That is correct. Per the information available on clinicaltrials.gov, this medical trial posted on May 22nd 2023 and was recently updated June 6th 2023 is actively recruiting patients with a target of 2124 participants from 1 site."
Answered by AI
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