Maternal Oxygen Administration for Fetal Distress II

Fetal Distress Clinical Trial

Official title:

The Effect of Maternal Long Term High Flow Oxygen Administration During Labor on Umbilical Cord Blood Gases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764696
• Other study ID #: CYH002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2023
• 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.

The investigators found the use of 2 L/min maternal oxygen during the second stage of labor did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR) pattern distribution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

at term (>37 weeks, <42 weeks), singleton, cephalic presentation, spontaneous or induced labor, normal labor, category I FHR tracings, 2 to 3 cm of cervical dilation in nulliparity, 1 to 2 cm of cervical dilation in multipara, informed consent.

Exclusion Criteria:

respiratory or cardiovascular disease, diabetes mellitus or insulin-treated gestational diabetes mellitus, hypertension or preeclampsia, oligohydramnios, fetal growth restriction, placental abruption, cephalopelvic disproportion, meconium-stained amniotic fluid, tachysystole, having received O2, uterine incision (myomectomy or perforation), anemia, fever, chorioamnionitis, tobacco or alcohol use, disorders in oxygen saturations, hypotension, uncomfortable with facemask.

Related Conditions & MeSH terms

• Fetal Distress
• Labour
• Oxygen Inhalation Therapy

Intervention

Device:
• tight-fitting simple facemask
Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center	Beijing
China	Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital	Beijing
China	Department of Obstetrics and Gynecology, Sixth Medical Center, Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (2)

Chuai F, Dong T, Liu Y, Jiang W, Zhang L, Chen L, Chuai Y, Zhou Y. The effect of intrapartum prolonged oxygen exposure on fetal metabolic status: secondary analysis from a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Jun 27;14:1204956. doi: 10.3389/fendo.2023.1204956. eCollection 2023. — View Citation

Chuai Y, Jiang W, Zhang L, Chuai F, Sun X, Peng K, Gao J, Dong T, Chen L, Yao Y. Effect of long-duration oxygen vs room air during labor on umbilical cord venous partial pressure of oxygen: a randomized controlled trial. Am J Obstet Gynecol. 2022 Oct;227(4):629.e1-629.e16. doi: 10.1016/j.ajog.2022.05.028. Epub 2022 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of cesarean delivery		at 1 minute after birth
Other	Rate of assisted vaginal delivery		at 1 minute after birth
Other	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 (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 1 and 5 minutes after birth
Other	Rate of serious neonatal morbidity or death		within 28 days of birth
Other	Cord arterial plasma liquid chromatography mass spectrometry analysis	The systematic identification and quantitation of all the metabolic products (mainly endogenous small molecule compounds with relative molecular weight within 1000 Da) of cord arterial plasma under oxygen and room air conditions. Immediately after delivery (within 30-60 seconds of birth), blood plasma sample will be obtained.	within 30 to 60 seconds of birth
Primary	Cord arterial pH values	Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.	within 30 to 60 seconds of birth
Primary	Cord arterial partial pressure of oxygen	Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.	within 30 to 60 seconds of birth
Primary	Cord arterial partial pressure of carbon dioxide	Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.	within 30 to 60 seconds of birth
Primary	Cord venous pH values	Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.	within 30 to 60 seconds of birth
Primary	Cord venous partial pressure of oxygen	Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.	within 30 to 60 seconds of birth
Primary	Cord venous partial pressure of carbon dioxide	Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.	within 30 to 60 seconds of birth
Secondary	Rate of abnormal fetal heart tracing		at 1 minute after birth