Completed

NCT Number: NCT02221440

Maternal Oxygen Administration for Fetal Distress

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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Navy General Hospital., Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Low flow nasal oxygen

Device

Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery

Low flow room air

Device

Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.

Primary outcomes

cord arterial pH values (hydrogen ion concentration) less than 7.2

Time frame: within 30-60 seconds of birth

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

Secondary outcomes

Apgar score less than 7

Time frame: at one and five 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 to form a backronym (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.
maternal radial arterial partial pressure of oxygen

Time frame: within 30-60 seconds of birth

Immediately after delivery (within 30-60 seconds of birth), radial artery blood gas sample will be obtained.
umbilical cord venous partial pressure of oxygen

Time frame: within 30-60 seconds of birth

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

Other outcomes

cesarean delivery rate

Time frame: during the second stage of labor
assisted vaginal delivery

Time frame: during the second stage of labor
maternal dissatisfaction

Time frame: during the second stage of labor
abnormal fetal heart rate tracing

Time frame: during the second stage of labor
neonatal resuscitation

Time frame: within 10 mins of birth
neonatal encephalopathy

Time frame: within 24 hours of birth
serious neonatal morbidity or death

Time frame: within 28 days of birth

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 20, 2014
Registry last updated: May 26, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed