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
| Type | Name | Description |
|---|---|---|
| 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 |
| DEVICE | Low flow room air | Sham: 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.