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Maternal Oxygen Administration for Fetal Distress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221440
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Yunhai Chuai, Navy General Hospital, Beijing

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.

Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second stage of labor can relieve fetal distress.


Condition or disease Intervention/treatment Phase
Oxygen Inhalation Therapy Second Stage of Labour Fetal Distress Device: Low flow nasal oxygen Device: Low flow room air Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Placebo Comparator: air, second stage of labor

Patients randomized to the group will receive sham administered by nasal catheter.

The therapy will continue until after delivery

Device: Low flow room air
Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.

Experimental: oxygen, second stage of labor

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

Device: Low flow nasal oxygen
Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Apgar score less than 7 [ Time Frame: at one and five minutes after birth ]

    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.


  2. maternal radial arterial partial pressure of oxygen [ Time Frame: within 30-60 seconds of birth ]
    Immediately after delivery (within 30-60 seconds of birth), radial artery blood gas sample will be obtained.

  3. umbilical cord venous partial pressure of oxygen [ Time Frame: within 30-60 seconds of birth ]
    Immediately after delivery (within 30-60 seconds of birth), umbilical cord venous blood gas sample will be obtained.


Other Outcome Measures:
  1. cesarean delivery rate [ Time Frame: during the second stage of labor ]
  2. assisted vaginal delivery [ Time Frame: during the second stage of labor ]
  3. maternal dissatisfaction [ Time Frame: during the second stage of labor ]
  4. abnormal fetal heart rate tracing [ Time Frame: during the second stage of labor ]
  5. neonatal resuscitation [ Time Frame: within 10 mins of birth ]
  6. neonatal encephalopathy [ Time Frame: within 24 hours of birth ]
  7. serious neonatal morbidity or death [ Time Frame: within 28 days of birth ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • respiratory disease
  • cardiovascular disease
  • diabetes mellitus or insulin-treated gestational diabetes mellitus
  • hypertension or preeclampsia
  • oligohydramnios
  • fetal growth restriction
  • placental abruption
  • anemia
  • disorders in oxygen saturations
  • received oxygen therapy in the first stage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221440


Locations
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China, Beijing
Department of Obstetrics and Gynecology, Navy General Hospital.
Beijing, Beijing, China, 100048
Navy General Hospital
Beijing, Beijing, China, 100048
China
Department of Obstetrics and Gynecology, Navy General Hospital.
Beijing, China, 100048
Sponsors and Collaborators
Navy General Hospital, Beijing
Investigators
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Principal Investigator: Yunhai Chuai, Dr Navy General Hospital, Beijing
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yunhai Chuai, Department of Obstetrics and Gynecology, Navy General Hospital, Beijing, Navy General Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02221440    
Other Study ID Numbers: CYH001
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Fetal Distress