N/A
N=844
The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor
Maternal Oxygen Use in Labor
Bottom Line
View on ClinicalTrials.gov: NCT02752490 ↗Enrolled (actual)
844
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Number of Participants Who Delivered by Cesarean — 83; 75 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Liberal use of maternal oxygen (Drug); Indicated use of maternal oxygen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Delivered by Cesarean |
83; 75 | — |
| SECONDARY Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth |
7; 12 | — |
| SECONDARY Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status |
37; 39 | — |
| SECONDARY Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes |
4; 13 | — |
| SECONDARY Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU) |
38; 42 | — |
| SECONDARY Total Duration of Maternal Oxygen Use |
89; 87 | — |
| SECONDARY Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen |
240; 236; 121; 118; 13; 11 | — |
| SECONDARY Number of Participants With Clinical Chorioamnionitis |
16; 14 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02752490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.