Maternal Oxygen Administration for Fetal Distress II

Navy General Hospital, Beijing

Status: Completed

Conditions: Labour; Oxygen Inhalation Therapy; Fetal Distress

Treatments: Device: tight-fitting simple facemask

Study type: Interventional

Funder types: Other

Identifiers

NCT03764696

CYH002

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.

The investigators found the use of 2 L/min maternal oxygen during the second stage of labor did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR) pattern distribution.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

at term (>37 weeks, <42 weeks), singleton, cephalic presentation, spontaneous or induced labor, normal labor, category I FHR tracings, 2 to 3 cm of cervical dilation in nulliparity, 1 to 2 cm of cervical dilation in multipara, informed consent.

Exclusion criteria

respiratory or cardiovascular disease, diabetes mellitus or insulin-treated gestational diabetes mellitus, hypertension or preeclampsia, oligohydramnios, fetal growth restriction, placental abruption, cephalopelvic disproportion, meconium-stained amniotic fluid, tachysystole, having received O2, uterine incision (myomectomy or perforation), anemia, fever, chorioamnionitis, tobacco or alcohol use, disorders in oxygen saturations, hypotension, uncomfortable with facemask.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

air, the first and second stage of labor

No Intervention group

Description:

Patients randomized to the group will receive room air. The therapy will continue until after delivery

oxygen, the first and second stage of labor

Experimental group

Description:

Patients randomized to the group will receive oxygen administered by high flow facemask oxygen at 10 L/min oxygen. The therapy will continue until after delivery

Treatment:

Device: tight-fitting simple facemask