Maternal Oxygen Administration for Fetal Distress II

NCT03764696 | Completed

• 1 other identifier: CYH002
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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. 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.

Conditions

Oxygen Inhalation Therapy; Labour; Fetal Distress

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Rate of abnormal fetal heart tracing

  at 1 minute after birth

Other Outcomes (5)

• Rate of cesarean delivery

  at 1 minute after birth

• Rate of assisted vaginal delivery

  at 1 minute after birth

• Apgar score less than 7

  at 1 and 5 minutes after birth

Study Arms (2)

air, the first and second stage of labor

NO INTERVENTION

Patients randomized to the group will receive room air. The therapy will continue until after delivery

oxygen, the first and second stage of labor

EXPERIMENTAL

Patients randomized to the group will receive oxygen administered by high flow facemask oxygen at 10 L/min oxygen. The therapy will continue until after delivery

Device: tight-fitting simple facemask

Interventions

tight-fitting simple facemask DEVICE

Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery

oxygen, the first and second stage of labor

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (3)

Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center

Beijing, China

Location

Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital

Beijing, China

Location

Department of Obstetrics and Gynecology, Sixth Medical Center, Chinese PLA General Hospital

Beijing, China

Location

Related 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.

  PMID: 37441500 BACKGROUND

• 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.

  PMID: 35580635 BACKGROUND

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yunhai Chuai, Dr

  Sixth Medical Center, Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Fang Chuai

  Sixth Medical Center, Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Obstetrics and Gynecology, Principal Investigator

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: January 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

CN (3)