Back to resultsMaternal Oxygen Administration for Fetal Distress II
Primary Purpose
Oxygen Inhalation Therapy, Labour, Fetal Distress
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tight-fitting simple facemask
Sponsored by
About this trial
This is an interventional prevention trial for Oxygen Inhalation Therapy
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.
Sites / Locations
- Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center
- Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital
- Department of Obstetrics and Gynecology, Sixth Medical Center, Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
air, the first and second stage of labor
oxygen, the first and second stage of labor
Arm Description
Patients randomized to the group will receive room air. The therapy will continue until after delivery
Patients randomized to the group will receive oxygen administered by high flow facemask oxygen at 10 L/min oxygen. The therapy will continue until after delivery
Outcomes
Primary Outcome Measures
Cord arterial pH values
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord arterial partial pressure of oxygen
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord arterial partial pressure of carbon dioxide
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord venous pH values
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord venous partial pressure of oxygen
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord venous partial pressure of carbon dioxide
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Secondary Outcome Measures
Rate of abnormal fetal heart tracing
Full Information
NCT ID
NCT03764696
First Posted
December 3, 2018
Last Updated
August 13, 2023
Sponsor
Navy General Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT03764696
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navy General Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Inhalation Therapy, Labour, Fetal Distress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
air, the first and second stage of labor
Arm Type
No Intervention
Arm Description
Patients randomized to the group will receive room air.
The therapy will continue until after delivery
Arm Title
oxygen, the first and second stage of labor
Arm Type
Experimental
Arm Description
Patients randomized to the group will receive oxygen administered by high flow facemask oxygen at 10 L/min oxygen.
The therapy will continue until after delivery
Intervention Type
Device
Intervention Name(s)
tight-fitting simple facemask
Intervention Description
Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery
Primary Outcome Measure Information:
Title
Cord arterial pH values
Description
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Time Frame
within 30 to 60 seconds of birth
Title
Cord arterial partial pressure of oxygen
Description
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Time Frame
within 30 to 60 seconds of birth
Title
Cord arterial partial pressure of carbon dioxide
Description
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Time Frame
within 30 to 60 seconds of birth
Title
Cord venous pH values
Description
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Time Frame
within 30 to 60 seconds of birth
Title
Cord venous partial pressure of oxygen
Description
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Time Frame
within 30 to 60 seconds of birth
Title
Cord venous partial pressure of carbon dioxide
Description
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Time Frame
within 30 to 60 seconds of birth
Secondary Outcome Measure Information:
Title
Rate of abnormal fetal heart tracing
Time Frame
at 1 minute after birth
Other Pre-specified Outcome Measures:
Title
Rate of cesarean delivery
Time Frame
at 1 minute after birth
Title
Rate of assisted vaginal delivery
Time Frame
at 1 minute after birth
Title
Apgar score less than 7
Description
The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar score ranges from 0 to 10. The five criteria are summarized using words chosen (Appearance, Pulse, Grimace, Activity, Respiration). The infant is given a score of 0, 1 or 2. The scores are added up and the total sum is their Apgar score.
The test is generally done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Time Frame
at 1 and 5 minutes after birth
Title
Rate of serious neonatal morbidity or death
Time Frame
within 28 days of birth
Title
Cord arterial plasma liquid chromatography mass spectrometry analysis
Description
The systematic identification and quantitation of all the metabolic products (mainly endogenous small molecule compounds with relative molecular weight within 1000 Da) of cord arterial plasma under oxygen and room air conditions. Immediately after delivery (within 30-60 seconds of birth), blood plasma sample will be obtained.
Time Frame
within 30 to 60 seconds of birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunhai Chuai, Dr
Organizational Affiliation
Sixth Medical Center, Chinese PLA General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fang Chuai
Organizational Affiliation
Sixth Medical Center, Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center
City
Beijing
Country
China
Facility Name
Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital
City
Beijing
Country
China
Facility Name
Department of Obstetrics and Gynecology, Sixth Medical Center, Chinese PLA General Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
37441500
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.
Results Reference
background
PubMed Identifier
35580635
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.
Results Reference
background
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Maternal Oxygen Administration for Fetal Distress II
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