Oxygen Inhalation TherapyNCT02221440
Maternal Oxygen Administration for Fetal Distress
A study testing Low flow nasal oxygen and Low flow room air in people with Oxygen Inhalation Therapy and Second Stage of 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 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxygen Inhalation Therapy, Second Stage of Labour, Fetal Distress
- What is being tested?
- Low flow nasal oxygen and Low flow room air
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 443 participants
- Where
- 3 sitesChina
- Study dates
- Sep 2014to May 2015
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at term
- singleton
- primigraida
- cephalic presentation
- spontaneous or induced labor
- normal labor
- normal FHR tracings in the first stage
- at the onset of second stage
Who cannot join
- respiratory disease
- cardiovascular disease
- diabetes mellitus or insulin-treated gestational diabetes mellitus
- hypertension or preeclampsia
- oligohydramnios
- fetal growth restriction
Show all 10Show fewer
- placental abruption
- anemia
- disorders in oxygen saturations
- received oxygen therapy in the first stage
Trial locations and contacts
3 sites in 1 country.
China3 sites
Department of Obstetrics and Gynecology, Navy General Hospital.
Beijing, Beijing Municipality, 100048
Navy General Hospital
Beijing, Beijing Municipality, 100048
Department of Obstetrics and Gynecology, Navy General Hospital.
Beijing, 100048
About this study
Official title: Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress
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.
Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second stage of labor can relieve fetal distress.
Read the detailed description
A report from the cochran library (Cochrane Database Syst Rev. 2012 Dec 12;12:CD000136.):
Too little evidence to show whether oxygen administration to the woman during labour is beneficial to the baby.
Some babies show signs of distress, such as unusual heart rates or the passing of a bowel motion (meconium) during their mother's labour. This may be caused by a lack of oxygen passing from the woman to the baby through the placenta. Sometimes, women may be encouraged to breathe extra oxygen through a facemask (oxygen administration) to increase the oxygen available to the unborn baby. A review of two trials found too little evidence to show whether oxygen administration to the woman during the second stage of labour is beneficial to the baby. No trials of oxygen administration when the baby is showing signs of distress were found. Further research is needed.
- Being tested
- Low flow nasal oxygen, Low flow room air
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow nasal oxygenDevice
Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery
Low flow room airDevice
Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.
| Study group | Role | What they receive |
|---|---|---|
| air, second stage of labor | Placebo comparator | Patients randomized to the group will receive sham administered by nasal catheter.
The therapy will continue until after delivery Receives: Device: Low flow room air |
| oxygen, second stage of labor | Experimental | Patients randomized to the group will receive oxygen administered by low flow nasal oxygen at a flow rate of 2 L/min.
The therapy will continue until after delivery Receives: Device: Low flow nasal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
cord arterial pH values (hydrogen ion concentration) less than 7.2
Immediately after delivery (within 30-60 seconds of birth), umbilical cord arterial blood gas sample will be obtained.
Measured: within 30-60 seconds of birth
Secondary outcomes (3)
Apgar score less than 7
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 to form a backronym (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.
Measured: at one and five minutes after birth
maternal radial arterial partial pressure of oxygen
Immediately after delivery (within 30-60 seconds of birth), radial artery blood gas sample will be obtained.
Measured: within 30-60 seconds of birth
umbilical cord venous partial pressure of oxygen
Immediately after delivery (within 30-60 seconds of birth), umbilical cord venous blood gas sample will be obtained.
Measured: within 30-60 seconds of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 443 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, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221440
- Sponsor's protocol ID
- CYH001
- Status last verified
- May 2020
- First submitted
- 16 Aug 2014
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Qian G, Xu X, Chen L, Xia S, Wang A, Chuai Y, Jiang W. The effect of maternal low flow oxygen administration during the second stage of labour on umbilical cord artery pH: a randomised controlled trial. BJOG. 2017 Mar;124(4):678-685. doi: 10.1111/1471-0528.14418.
PubMed 28224745Chuai Y, Jiang W, Xu X, Wang A, Yao Y, Chen L. Maternal oxygen exposure may not change umbilical cord venous partial pressure of oxygen: non-random, paired venous and arterial samples from a randomised controlled trial. BMC Pregnancy Childbirth. 2020 Sep 4;20(1):510. doi: 10.1186/s12884-020-03212-3.
PubMed 32887557
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress
- ClinicalTrials.gov ID
- NCT02221440
- Acronym / sponsor ID
- CYH001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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.
Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second stage of labor can relieve fetal distress.
Detailed description
A report from the cochran library (Cochrane Database Syst Rev. 2012 Dec 12;12:CD000136.):
Too little evidence to show whether oxygen administration to the woman during labour is beneficial to the baby.
Some babies show signs of distress, such as unusual heart rates or the passing of a bowel motion (meconium) during their mother's labour. This may be caused by a lack of oxygen passing from the woman to the baby through the placenta. Sometimes, women may be encouraged to breathe extra oxygen through a facemask (oxygen administration) to increase the oxygen available to the unborn baby. A review of two trials found too little evidence to show whether oxygen administration to the woman during the second stage of labour is beneficial to the baby. No trials of oxygen administration when the baby is showing signs of distress were found. Further research is needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| air, second stage of labor | Placebo comparator | Device: Low flow room airPatients randomized to the group will receive sham administered by nasal catheter. The therapy will continue until after delivery |
| oxygen, second stage of labor | Experimental | Device: Low flow nasal oxygenPatients randomized to the group will receive oxygen administered by low flow nasal oxygen at a flow rate of 2 L/min. The therapy will continue until after delivery |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- at term
- singleton
- primigraida
- cephalic presentation
- spontaneous or induced labor
Key exclusion criteria (10 listed)
- respiratory disease
- cardiovascular disease
- diabetes mellitus or insulin-treated gestational diabetes mellitus
- hypertension or preeclampsia
- oligohydramnios
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 |
|---|---|---|
| Low flow nasal oxygenOxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery | Device | oxygen, second stage of labor |
| Low flow room airSham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min. | Device | air, second stage of labor |
Primary outcome
cord arterial pH values (hydrogen ion concentration) less than 7.2
Time frame: within 30-60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), umbilical cord arterial blood gas sample will be obtained.
3 secondary outcomes
Apgar score less than 7
Time frame: at one and five minutes after birth
maternal radial arterial partial pressure of oxygen
Time frame: within 30-60 seconds of birth
umbilical cord venous partial pressure of oxygen
Time frame: within 30-60 seconds of 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 26 May 2020.
- Results publication: PubMed 28224745Qian G, Xu X, Chen L, Xia S, Wang A, Chuai Y, Jiang W. The effect of maternal low flow oxygen administration during the second stage of labour on umbilical cord artery pH: a randomised controlled trial. BJOG. 2017 Mar;124(4):678-685. doi: 10.1111/1471-0528.14418.
- Derived from this study: PubMed 32887557Chuai Y, Jiang W, Xu X, Wang A, Yao Y, Chen L. Maternal oxygen exposure may not change umbilical cord venous partial pressure of oxygen: non-random, paired venous and arterial samples from a randomised controlled trial. BMC Pregnancy Childbirth. 2020 Sep 4;20(1):510. doi: 10.1186/s12884-020-03212-3.
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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
Navy General Hospital, Beijing
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low flow nasal oxygen and Low flow room air in people with Oxygen Inhalation Therapy and Second Stage of 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 8 inclusion and 10 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 26 May 2020. 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. Some participants in this study may receive a placebo. 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 (hydrogen ion concentration) less than 7.2 (time frame: within 30-60 seconds of birth). 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 NCT02221440, 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 26 May 2020.