Clinical Trial: Maternal Oxygen Administration for Fetal Distress
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress
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.
Detailed Summary:
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.
Sponsor: Navy General Hospital, Beijing
Current Primary Outcome: cord arterial pH values (hydrogen ion concentration) less than 7.2 [ Time Frame: within 30-60 seconds of birth ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
- 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.
Original Secondary Outcome: 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.
Information By: Navy General Hospital, Beijing
Dates:
Date Received: August 16, 2014
Date Started: September 2014
Date Completion:
Last Updated: May 25, 2015
Last Verified: May 2015
