Maternal Oxygen Administration for Fetal Distress II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Oxygen Inhalation Therapy Labour Fetal Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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air, the first and second stage of labor

Patients randomized to the group will receive room air.

The therapy will continue until after delivery

Group Type NO_INTERVENTION

No interventions assigned to this group

oxygen, the first and second stage of labor

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

Group Type EXPERIMENTAL

tight-fitting simple facemask

Intervention Type DEVICE

Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery

Interventions

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tight-fitting simple facemask

Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes