The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor

NCT ID: NCT02752490

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 844 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-07-31

Brief Summary

The objective of this study is to determine if a strategy of indicated compared to liberal oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is that women who undergo a strategy of indicated compared to liberal oxygen administration in labor will have lower rate of cesarean delivery and fetal acidemia at birth.

Detailed Description

This is a single-site before and after study comparing the strategy of liberal versus indicated use of maternal oxygen in the first and second stages of labor in the setting of a category 2 fetal heart rate tracing (FHR) tracing, as defined by American Congress of Obstetrics and Gynecology (ACOG) and National Institute of Child Health and Human Development (NICHD) guidelines. All patients who are at term and are undergoing labor at Memorial Hermann Hospital in Houston, Texas during the time frame of the study will be included in the study. The study will be conducted over 18 weeks. It will involve two 8 week time periods during which all patients will under either a strategy of liberal administration of oxygen use (current practice) in the "before" portion of the study and indicated administration of oxygen in the "after" portion of the study (new practice). There will be a transition period where training, education, and audit + feedback will be done to prepare for a strategy of indicated administration of oxygen.

Conditions

Maternal Oxygen Use in Labor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liberal use of maternal oxygen

Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician

Group Type: ACTIVE_COMPARATOR

Liberal use of maternal oxygen

Intervention Type: DRUG

Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by ACOG10 at the discretion of the primary nurse or physician

Indicated use of maternal oxygen

Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.

Group Type: EXPERIMENTAL

Indicated use of maternal oxygen

Intervention Type: DRUG

Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.

Interventions

Liberal use of maternal oxygen

Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by ACOG10 at the discretion of the primary nurse or physician

Intervention Type: DRUG

Indicated use of maternal oxygen

Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pregnant women with singleton gestation between 37 weeks 0 days to 42 weeks 0 days gestation who present to labor and delivery at Memorial Hermann Hospital in Houston, TX for planned labor attempt.

Exclusion Criteria

• Lethal fetal anomaly defined as anomaly in which the fetus is unlikely to survive or the neonate is not expected to survive to initial hospital discharge
• Antepartum or intrapartum fetal demise
• Preexisting maternal conditions requiring oxygen for maternal indication, including but not limited to: Asthma that has required intubation or hospitalization in the past or currently requiring steroids (either inhaled or oral); Chronic obstructive pulmonary disease; Chronic bronchitis; Congestive heart failure/peripartum cardiomyopathy; Pneumonia; Pulmonary edema; Pulmonary embolus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Nanaama Ankumah Bentum

Clinical Fellow PGY 6

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nana-Ama E Ankumah, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Children's Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-16-0142

Identifier Type: -

Identifier Source: org_study_id