Oxygen Inhalation TherapyNCT03764696
Maternal Oxygen Administration for Fetal Distress II
A study testing tight-fitting simple facemask in people with Oxygen Inhalation Therapy and Labour, run by Navy General Hospital, Beijing at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxygen Inhalation Therapy, Labour, Fetal Distress
- What is being tested?
- tight-fitting simple facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center
Beijing
Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital
Beijing
Department of Obstetrics and Gynecology, Sixth Medical Center, Chinese PLA General Hospital
Beijing
About this study
Official title: The Effect of Maternal Long Term High Flow Oxygen Administration During Labor on Umbilical Cord Blood Gases
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.
- Conditions
- Oxygen Inhalation Therapy, Labour, Fetal Distress
- Being tested
- tight-fitting simple facemask
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tight-fitting simple facemaskDevice
Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery
| Study group | Role | What they receive |
|---|---|---|
| air, the first and second stage of labor | No intervention | Patients randomized to the group will receive room air. The therapy will continue until after delivery |
| oxygen, the first and second stage of labor | Experimental | 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 Receives: Device: tight-fitting simple facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cord arterial pH values
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Measured: within 30 to 60 seconds of birth
Cord arterial partial pressure of oxygen
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Measured: within 30 to 60 seconds of birth
Cord arterial partial pressure of carbon dioxide
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Measured: within 30 to 60 seconds of birth
Cord venous pH values
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Measured: within 30 to 60 seconds of birth
Cord venous partial pressure of oxygen
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Measured: within 30 to 60 seconds of birth
Cord venous partial pressure of carbon dioxide
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Measured: within 30 to 60 seconds of birth
Secondary outcomes (1)
Rate of abnormal fetal heart tracing
Measured: at 1 minute after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jan 2021
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oxygen Inhalation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunhai Chuai, Navy General Hospital, Beijing
- Investigators
- Yunhai Chuai, Dr, Principal investigator, Sixth Medical Center, Chinese PLA General HospitalFang Chuai, Principal investigator, Sixth Medical Center, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764696
- Sponsor's protocol ID
- CYH002
- Status last verified
- Aug 2023
- First submitted
- 3 Dec 2018
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37441500Chuai 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.
PubMed 35580635
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Long Term High Flow Oxygen Administration During Labor on Umbilical Cord Blood Gases
- ClinicalTrials.gov ID
- NCT03764696
- Acronym / sponsor ID
- CYH002
- Conditions
- Oxygen Inhalation Therapy, Labour, Fetal Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| air, the first and second stage of labor | No intervention | –Patients randomized to the group will receive room air. The therapy will continue until after delivery |
| oxygen, the first and second stage of labor | Experimental | Device: tight-fitting simple facemaskPatients 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tight-fitting simple facemaskOxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery | Device | oxygen, the first and second stage of labor |
Primary outcome
Cord arterial pH values
Time frame: within 30 to 60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord arterial partial pressure of oxygen
Time frame: within 30 to 60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord arterial partial pressure of carbon dioxide
Time frame: within 30 to 60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord venous pH values
Time frame: within 30 to 60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord venous partial pressure of oxygen
Time frame: within 30 to 60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
Cord venous partial pressure of carbon dioxide
Time frame: within 30 to 60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
1 secondary outcome
Rate of abnormal fetal heart tracing
Time frame: at 1 minute after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 37441500Chuai 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.
- Background: PubMed 35580635Chuai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunhai Chuai, Dr principal investigator
Sixth Medical Center, Chinese PLA General Hospital
Fang Chuai principal investigator
Sixth Medical Center, Chinese PLA General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tight-fitting simple facemask in people with Oxygen Inhalation Therapy and Labour, run by Navy General Hospital, Beijing at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cord arterial pH values (time frame: within 30 to 60 seconds of birth). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764696, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.