Maternal Oxygen Administration for Fetal Distress

Not Applicable

Completed

• Conditions: Fetal Distress; Oxygen Inhalation Therapy; Second Stage of Labour

• Registration Number: NCT02221440
• Lead Sponsor: Navy General Hospital, Beijing

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.

Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second stage of labor can relieve fetal distress.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-08-16
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Study Start: 2014-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 443

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cord arterial pH values (hydrogen ion concentration) less than 7.2	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 Outcome Measures

Name	Time	Method
Apgar score less than 7	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	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	within 30-60 seconds of birth	Immediately after delivery (within 30-60 seconds of birth), umbilical cord venous blood gas sample will be obtained.

Trial Locations

Locations (2)

Department of Obstetrics and Gynecology, Navy General Hospital.; 🇨🇳 Beijing, China

Navy General Hospital; 🇨🇳 Beijing, Beijing, China