Completed

NCT Number: NCT03764696

Maternal Oxygen Administration for Fetal Distress II

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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Key information

Conditions

Oxygen Inhalation Therapy Fetal Distress Labour Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center, Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tight-fitting simple facemask

Device

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

Primary outcomes

Cord arterial pH values

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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 carbon dioxide

Time frame: within 30 to 60 seconds of birth

Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.

Secondary outcomes

Rate of abnormal fetal heart tracing

Time frame: at 1 minute after birth

Other outcomes

Rate of cesarean delivery

Time frame: at 1 minute after birth
Rate of assisted vaginal delivery

Time frame: at 1 minute after birth
Apgar score less than 7

Time frame: 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

Time frame: within 28 days of birth
Cord arterial plasma liquid chromatography mass spectrometry analysis

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

The Effect of Maternal Long Term High Flow Oxygen Administration During Labor on Umbilical Cord Blood Gases

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Dec 5, 2018
Registry last updated: Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed