Maternal Oxygen Administration for Fetal Distress

Fetal Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221440
• Other study ID #: CYH001
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2020
• Source: Navy General Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Distress
• Oxygen Inhalation Therapy
• Second Stage of Labour

Intervention

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

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynecology, Navy General Hospital.	Beijing	Beijing
China	Department of Obstetrics and Gynecology, Navy General Hospital.	Beijing
China	Navy General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (1)

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: 10.1111/1471-052 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cesarean delivery rate		during the second stage of labor
Other	assisted vaginal delivery		during the second stage of labor
Other	maternal dissatisfaction		during the second stage of labor
Other	abnormal fetal heart rate tracing		during the second stage of labor
Other	neonatal resuscitation		within 10 mins of birth
Other	neonatal encephalopathy		within 24 hours of birth
Other	serious neonatal morbidity or death		within 28 days of birth
Primary	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	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
Secondary	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
Secondary	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