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Oxygen Supplementation for Intrauterine Resuscitation (O2P2 Trial)

N/A

Waitlist Available

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

English speaking

Gestational age ≥37 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 hour of delivery

Awards & highlights

O2P2 Trial Summary

This trial is looking at the safety of giving oxygen to women in labor who are showing signs of fetal distress. They will be measuring levels of markers for oxidative stress in the mother and baby to see if there are any harmful effects from the oxygen.

Who is the study for?

This trial is for English-speaking women in labor or induced labor at ≥37 weeks with a single baby. They must be able to consent and have Category II EFM patterns. It excludes those with multiple babies, severe fetal monitoring issues, growth-restricted fetuses, pre-existing diabetes, smokers, major fetal anomalies, maternal hypoxia or preeclampsia.Check my eligibility

What is being tested?

The study compares the effects of giving oxygen (O2) versus room air (RA) to laboring women on both mothers and newborns. It focuses on whether O2 increases oxidative stress as shown by markers like MDA and 4-HNE in umbilical cord blood and maternal samples.See study design

What are the potential side effects?

While not explicitly stated for this trial, potential side effects of oxygen supplementation could include dry or irritated throat for the mother and increased risk of conditions related to high oxygen levels such as retinopathy in neonates.

O2P2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English.

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My pregnancy has reached or passed 37 weeks.

O2P2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 hour of delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 hour of delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 hour of delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maternal 4-hydroxynonenal

Maternal malondialdehyde

Umbilical artery 4-hydroxynonenal

+1 more

O2P2 Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Room airActive Control1 Intervention

Room air (no mask)

Group II: OxygenPlacebo Group1 Intervention

10L/min Oxygen by facemask

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,497 Total Patients Enrolled

Media Library

No oxygen Clinical Trial Eligibility Overview. Trial Name: NCT03581214 — N/A

Intrauterine Resuscitation Research Study Groups: Room air, Oxygen

Intrauterine Resuscitation Clinical Trial 2023: No oxygen Highlights & Side Effects. Trial Name: NCT03581214 — N/A

No oxygen 2023 Treatment Timeline for Medical Study. Trial Name: NCT03581214 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this experiment?

"Affirmative. Clinicaltrials.gov indicates that recruitment for this research endeavour is still ongoing, following its initial posting on July 15th 2018 and most recent alteration on August 24th 2022. The team requires 212 participants from one site to complete the trial."

Answered by AI

Can anyone still participate in this scientific investigation?

"Affirmative. Clinicaltrials.gov documents that the medical trial, initially published on July 15th 2018, is currently recruiting patients. 212 individuals will be accepted from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Nandini Raghuraman 2018. "Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03581214.