Clinical trial NCT02221440: Maternal Oxygen Administration for Fetal Distress
Official title: Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Inhalation Therapy
Second Stage of Labour
Fetal Distress
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 443
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: cord arterial pH values (hydrogen ion concentration) less than 7.2
timeFrame: within 30-60 seconds of birth
Secondary outcomes:
measure: Apgar score less than 7
timeFrame: at one and five minutes after birth
measure: maternal radial arterial partial pressure of oxygen
timeFrame: within 30-60 seconds of birth
measure: umbilical cord venous partial pressure of oxygen
timeFrame: within 30-60 seconds of birth
Other outcomes:
measure: cesarean delivery rate
timeFrame: during the second stage of labor
measure: assisted vaginal delivery
timeFrame: during the second stage of labor
measure: maternal dissatisfaction
timeFrame: during the second stage of labor
measure: abnormal fetal heart rate tracing
timeFrame: during the second stage of labor
measure: neonatal resuscitation
timeFrame: within 10 mins of birth
measure: neonatal encephalopathy
timeFrame: within 24 hours of birth
measure: serious neonatal morbidity or death
timeFrame: within 28 days of birth
Locations:
city: Beijing
country: China
facility: Department of Obstetrics and Gynecology, Navy General Hospital.
state: Beijing
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Obstetrics and Gynecology, Navy General Hospital.
Study officials:
affiliation: Navy General Hospital, Beijing
name: Yunhai Chuai, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.