Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities

NCT03996317 | Withdrawn DMC

• 1 other identifier: 5190191
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Perinatal death

  Death during intrapartum or neonatal period

  Delivery through discharge and average of 1 week

• Respiratory distress syndrome

  Need for respiratory support up to 72 hours of life

  Delivery through 72 hrs of life

• Low 5 minute Apgar score

  5 minute Apgar score \<=3

  At 5 minute of life

• Hypoxic-ischemic encephalopathy

  Delivery through discharge and average of 1 week

• Neonatal seizure

  Seizure or seizure like activity during the neonatal period.

  Delivery through discharge and average of 1 week

• Meconium aspiration syndrome

  Delivery through discharge and average of 1 week

• Intracranial hemorrhage

  Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma

  Delivery through discharge and average of 1 week

• Neonatal hypotension

  hypotension (low average blood pressure) based on weight requiring vasopressor support (medication to increase blood pressure).

  Delivery through discharge and average of 1 week

Study Arms (2)

Standard care

NO INTERVENTION

Standard practice where 10L/min O2 is delivered to patient by mask when any fetal tracing abnormalities are identified.

Room air

EXPERIMENTAL

O2 will be withheld at times when fetal tracing abnormalities are identified. Patient will continue to breath room air.

Other: Room air

Interventions

Room air OTHER

Avoidance of hyperoxygenation

Room air

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Perinatal Death; Respiratory Distress Syndrome, Newborn; Hypoxia-Ischemia, Brain; Meconium Aspiration Syndrome; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Lung Injury; Fetal Diseases; Hemorrhage

Study Officials

• Ruofan Yao, MD MPH

  Loma Linda University Medical Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 24, 2019
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)