Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low flow nasal oxygen | Device | Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 30-60 seconds of birth |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| cesarean delivery rate | during the second stage of labor | |
| assisted vaginal delivery | during the second stage of labor | |
| maternal dissatisfaction |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yunhai Chuai, Dr | Navy General Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Navy General Hospital. | Beijing | Beijing Municipality | 100048 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28224745 | Result | 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. | |
| 32887557 | Derived | Chuai 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005316 | Fetal Distress |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low flow room air | Device | Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min. |
|
| 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. | 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. | within 30-60 seconds of birth |
| during the second stage of labor |
| abnormal fetal heart rate tracing | during the second stage of labor |
| neonatal resuscitation | within 10 mins of birth |
| neonatal encephalopathy | within 24 hours of birth |
| serious neonatal morbidity or death | within 28 days of birth |
| Navy General Hospital |
| Beijing |
| Beijing Municipality |
| 100048 |
| China |
| Department of Obstetrics and Gynecology, Navy General Hospital. | Beijing | 100048 | China |