Fetal Distress, Labour, Oxygen Inhalation Therapy
Conditions
Brief 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. 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.
Interventions
DEVICEtight-fitting simple facemask
Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cord venous partial pressure of carbon dioxide | within 30 to 60 seconds of birth | Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained. |
| Cord arterial pH values | within 30 to 60 seconds of birth | Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained. |
| Cord arterial partial pressure of oxygen | within 30 to 60 seconds of birth | Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained. |
| Cord arterial partial pressure of carbon dioxide | within 30 to 60 seconds of birth | Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained. |
| Cord venous pH values | within 30 to 60 seconds of birth | Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained. |
| Cord venous partial pressure of oxygen | within 30 to 60 seconds of birth | Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained. |
Secondary
| Measure | Time frame |
|---|---|
| Rate of abnormal fetal heart tracing | at 1 minute after birth |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of cesarean delivery | at 1 minute after birth | — |
| Rate of assisted vaginal delivery | at 1 minute after birth | — |
| Apgar score less than 7 | at 1 and 5 minutes after birth | 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 (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. |
| Rate of serious neonatal morbidity or death | within 28 days of birth | — |
| Cord arterial plasma liquid chromatography mass spectrometry analysis | within 30 to 60 seconds of birth | The systematic identification and quantitation of all the metabolic products (mainly endogenous small molecule compounds with relative molecular weight within 1000 Da) of cord arterial plasma under oxygen and room air conditions. Immediately after delivery (within 30-60 seconds of birth), blood plasma sample will be obtained. |
Countries
China
Outcome results
None listed