Clinical trial NCT02752490: The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor
Official title: The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor: a Controlled Before and After Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Oxygen Use in Labor
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 844
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Delivered by Cesarean
timeFrame: at time of birth
Secondary outcomes:
measure: Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth
timeFrame: at time of birth
measure: Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status
timeFrame: at time of birth
measure: Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes
timeFrame: 5 minutes after birth
measure: Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU)
timeFrame: from time of birth to discharge from hospital (an average of 2-4 days)
measure: Total Duration of Maternal Oxygen Use
timeFrame: during labor
measure: Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen
timeFrame: during labor
measure: Number of Participants With Clinical Chorioamnionitis
timeFrame: during labor
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nana-Ama E Ankumah, MD
role: PRINCIPAL_INVESTIGATOR
References: