Clinical trial NCT03764696: Maternal Oxygen Administration for Fetal Distress II
Official title: The Effect of Maternal Long Term High Flow Oxygen Administration During Labor on Umbilical Cord Blood Gases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Inhalation Therapy
Labour
Fetal Distress
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Supplementary oxygen is routinely administered to patients, even those with adequate oxygen saturations, in the belief that it increases oxygen delivery. However, oxygen delivery depends not just on arterial oxygen content but also on perfusion.

Maternal oxygen administration has been used in an attempt to lessen fetal distress by increasing the available oxygen from the mother. However, the effect of supplemental maternal oxygen therapy on fetal acid base status has been debated for more than seven decades.

The investigators found the use of 2 L/min maternal oxygen during the second stage of labor did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR) pattern distribution.


Eligibility criteria: Inclusion Criteria:

at term (\>37 weeks, \<42 weeks), singleton, cephalic presentation, spontaneous or induced labor, normal labor, category I FHR tracings, 2 to 3 cm of cervical dilation in nulliparity, 1 to 2 cm of cervical dilation in multipara, informed consent.

Exclusion Criteria:

respiratory or cardiovascular disease, diabetes mellitus or insulin-treated gestational diabetes mellitus, hypertension or preeclampsia, oligohydramnios, fetal growth restriction, placental abruption, cephalopelvic disproportion, meconium-stained amniotic fluid, tachysystole, having received O2, uterine incision (myomectomy or perforation), anemia, fever, chorioamnionitis, tobacco or alcohol use, disorders in oxygen saturations, hypotension, uncomfortable with facemask.

Primary outcomes:
measure: Cord arterial pH values
timeFrame: within 30 to 60 seconds of birth
measure: Cord arterial partial pressure of oxygen
timeFrame: within 30 to 60 seconds of birth
measure: Cord arterial partial pressure of carbon dioxide
timeFrame: within 30 to 60 seconds of birth
measure: Cord venous pH values
timeFrame: within 30 to 60 seconds of birth
measure: Cord venous partial pressure of oxygen
timeFrame: within 30 to 60 seconds of birth
measure: Cord venous partial pressure of carbon dioxide
timeFrame: within 30 to 60 seconds of birth
Secondary outcomes:
measure: Rate of abnormal fetal heart tracing
timeFrame: at 1 minute after birth
Other outcomes:
measure: Rate of cesarean delivery
timeFrame: at 1 minute after birth
measure: Rate of assisted vaginal delivery
timeFrame: at 1 minute after birth
measure: Apgar score less than 7
timeFrame: at 1 and 5 minutes after birth
measure: Rate of serious neonatal morbidity or death
timeFrame: within 28 days of birth
measure: Cord arterial plasma liquid chromatography mass spectrometry analysis
timeFrame: within 30 to 60 seconds of birth
Locations:
city: Beijing
country: China
facility: Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center
city: Beijing
country: China
facility: Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital
city: Beijing
country: China
facility: Department of Obstetrics and Gynecology, Sixth Medical Center, Chinese PLA General Hospital
Study officials:
affiliation: Sixth Medical Center, Chinese PLA General Hospital
name: Yunhai Chuai, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Sixth Medical Center, Chinese PLA General Hospital
name: Fang Chuai
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chuai F, Dong T, Liu Y, Jiang W, Zhang L, Chen L, Chuai Y, Zhou Y. The effect of intrapartum prolonged oxygen exposure on fetal metabolic status: secondary analysis from a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Jun 27;14:1204956. doi: 10.3389/fendo.2023.1204956. eCollection 2023.
citation: Chuai Y, Jiang W, Zhang L, Chuai F, Sun X, Peng K, Gao J, Dong T, Chen L, Yao Y. Effect of long-duration oxygen vs room air during labor on umbilical cord venous partial pressure of oxygen: a randomized controlled trial. Am J Obstet Gynecol. 2022 Oct;227(4):629.e1-629.e16. doi: 10.1016/j.ajog.2022.05.028. Epub 2022 May 14.