Maternal Oxygen Administration for Fetal Distress

Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor 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.

Study Overview

• Status: Completed
• Conditions: Fetal Distress; Oxygen Inhalation Therapy; Second Stage of Labour
• Intervention / Treatment: Device: Low flow room air; Device: Low flow nasal oxygen

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 Type: Interventional
• Enrollment (Actual): 443
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100048
    • Department of Obstetrics and Gynecology, Navy General Hospital.
  • Beijing
    • Beijing, Beijing, China, 100048
      • Navy General Hospital
    • Beijing, Beijing, China, 100048
      • Department of Obstetrics and Gynecology, Navy General Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: air, second stage of labor; Patients randomized to the group will receive sham administered by nasal catheter. The therapy will continue until after delivery	Device: Low flow room air; Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.
EXPERIMENTAL: oxygen, second stage of labor; Patients randomized to the group will receive oxygen administered by low flow nasal oxygen at a flow rate of 2 L/min. The therapy will continue until after delivery	Device: Low flow nasal oxygen; Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cord arterial pH values (hydrogen ion concentration) less than 7.2	Immediately after delivery (within 30-60 seconds of birth), umbilical cord arterial blood gas sample will be obtained.	within 30-60 seconds of birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apgar score less than 7	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.	at one and five minutes after birth
maternal radial arterial partial pressure of oxygen	Immediately after delivery (within 30-60 seconds of birth), radial artery blood gas sample will be obtained.	within 30-60 seconds of birth
umbilical cord venous partial pressure of oxygen	Immediately after delivery (within 30-60 seconds of birth), umbilical cord venous blood gas sample will be obtained.	within 30-60 seconds of birth

Other Outcome Measures

Outcome Measure	Time Frame
cesarean delivery rate	during the second stage of labor
assisted vaginal delivery	during the second stage of labor
maternal dissatisfaction	during the second stage of labor
abnormal fetal heart rate tracing	during the second stage of labor
neonatal resuscitation	within 10 mins of birth
neonatal encephalopathy	within 24 hours of birth
serious neonatal morbidity or death	within 28 days of birth

Collaborators and Investigators

• Sponsor: Navy General Hospital, Beijing

Publications and helpful links

General Publications

• Qian G, Xu X, Chen L, Xia S, Wang A, Chuai Y, Jiang W. The effect of maternal low flow oxygen administration during the second stage of labour on umbilical cord artery pH: a randomised controlled trial. BJOG. 2017 Mar;124(4):678-685. doi: 10.1111/1471-0528.14418.
• Chuai Y, Jiang W, Xu X, Wang A, Yao Y, Chen L. Maternal oxygen exposure may not change umbilical cord venous partial pressure of oxygen: non-random, paired venous and arterial samples from a randomised controlled trial. BMC Pregnancy Childbirth. 2020 Sep 4;20(1):510. doi: 10.1186/s12884-020-03212-3.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: August 16, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (ESTIMATE): August 20, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fetal Distress
• Other Study ID Numbers: CYH001