Maternal Oxygen Administration for Fetal Distress

Navy General Hospital, Beijing

Status: Completed

Conditions: Second Stage of Labour; Oxygen Inhalation Therapy; Fetal Distress

Treatments: Device: Low flow room air; Device: Low flow nasal oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02221440

CYH001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 443 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

443 participants in 2 patient groups, including a placebo group

air, second stage of labor

Placebo Comparator group

Description:

Patients randomized to the group will receive sham administered by nasal catheter. The therapy will continue until after delivery

Treatment:

Device: Low flow room air

oxygen, second stage of labor

Experimental group

Description:

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

Treatment:

Device: Low flow nasal oxygen