N/A
N=114
Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings
Electronic Fetal Monitoring · Fetal Hypoxia · Fetal-Placental Circulation
Bottom Line
View on ClinicalTrials.gov: NCT02741284 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Mean Umbilical Artery Lactate at Delivery — 3.5; 3.4 mmol/L — p=0.69
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Room air (Drug); 10L Oxygen by nonrebreather mask (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Umbilical Artery Lactate at Delivery |
3.5; 3.4 | 0.69 |
| SECONDARY Umbilical Artery pH |
7.26; 7.25 | <0.05 sig |
| SECONDARY Mode of Delivery |
2; 6; 0; 2; 6; 1 | <0.05 sig |
| SECONDARY Umbilical Artery pCO2 |
55.9; 57.4 | 0.44 |
| SECONDARY Umbilical Artery pO2 |
19.7; 24.4 | 0.06 |
| SECONDARY Umbilical Artery Base Deficit |
-3.6; -3.6 | 0.99 |
Summary
Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is common practice on Labor and Delivery units in the United States. Despite the broad use of oxygen, it is unclear if this practice is beneficial for the fetus. The purpose of this study is to compare oxygen to room air in patients with Category II fetal heart tracings with regard to neonatal acid-base status, subsequent tracings, and production of reactive oxygen species
Eligibility Criteria
Inclusion Criteria
- Term, singleton patients admitted to Labor& Delivery for spontaneous labor or labor induction
Exclusion Criteria
- Multiple pregnancy
- Significant fetal anomalies
- Category III FHT
- Umbilical artery doppler abnormalities
- Maternal hypooxygenation or need for oxygen
Data sourced from ClinicalTrials.gov (NCT02741284). 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.