Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities

Withdrawn before enrolling · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03996317

Run by

Loma Linda University

People needed

0

Starts

2021-06-01

Expected to finish

2022-12-30

Last updated by the study team

2021-08-17

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Singleton pregnancy
• Gestational age between 37and0 weeks and 41and6 weeks
• Admitted for induction of labor or in active labor
• No known fetal anomalies

You may not qualify if…

• History of 2 or more cesarean delivery
• Maternal contraindications to labor
• Fetal contraindications to labor
• Maternal hemoglobin <8 on admission
• Maternal medical conditions requiring oxygen supplement at baseline (including but not limited to: severe cardiac conditions, uncontrolled asthma, pulmonary embolism, pulmonary fibrosis, pulmonary edema, pneumonia, sepsis etc.)

Where it is running

• Loma Linda University Children's Hospital — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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