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Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities

NCT03996317 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-08-17

No results posted yet for this study

Summary

Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice. Recent literature have either found no associated benefit to intrapartum maternal oxygen administration, or in a number of studies demonstrated higher risk of neonatal complications. Despite these studies, the evidences have not been adequate to change the clinical practice because the majority of these studies either focused on biological differences rather than clinical outcomes data or were retrospective rather than randomized trials. Therefore, the investigators propose a large single center randomized clinical trial to determine the effects of maternal hyperoxygenation therapy for the treatment of fetal heart rate tracing abnormalities.

Conditions

  • Perinatal Death
  • Respiratory Distress Syndrome, Newborn
  • Hypoxic-Ischemic Encephalopathy
  • Neonatal Seizure
  • Meconium Aspiration Syndrome
  • Intracranial Hemorrhages
  • Neonatal Hypotension

Interventions

OTHER

Room air

Avoidance of hyperoxygenation

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Ruofan Yao, MD MPH · Loma Linda University Medical Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-06-30
Completion
2022-12-30

Countries

  • United States

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 NCT03996317 on ClinicalTrials.gov