Clinical Trials Directory

Trials / Completed

CompletedNCT02221440

Maternal Oxygen Administration for Fetal Distress

Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
443 (actual)
Sponsor
Navy General Hospital, Beijing · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Accepted

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 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.

Conditions

Interventions

TypeNameDescription
DEVICELow flow nasal oxygenOxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery
DEVICELow flow room airSham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.

Timeline

Start date
2014-09-01
Primary completion
2015-05-01
Completion
2015-05-01
First posted
2014-08-20
Last updated
2020-05-26

Locations

3 sites across 1 country: China

Source: ClinicalTrials.gov record NCT02221440. Inclusion in this directory is not an endorsement.