Maternal Oxygen Administration for Fetal Distress II

August 13, 2023 updated by: Yunhai Chuai, Navy General Hospital, Beijing

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: air, the first and second stage of labor

Patients randomized to the group will receive room air.

The therapy will continue until after delivery
Experimental: oxygen, the first and second stage of labor

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
Oxygen will be administered by facemask at 10 L/min oxygen. 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
Time Frame: within 30 to 60 seconds of birth
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
Time Frame: within 30 to 60 seconds of birth
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
Time Frame: within 30 to 60 seconds of birth
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
Time Frame: within 30 to 60 seconds of birth
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
Time Frame: within 30 to 60 seconds of birth
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
Time Frame: within 30 to 60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
within 30 to 60 seconds of birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of abnormal fetal heart tracing
Time Frame: at 1 minute after birth
at 1 minute after birth

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of cesarean delivery
Time Frame: at 1 minute after birth
at 1 minute after birth
Rate of assisted vaginal delivery
Time Frame: at 1 minute after birth
at 1 minute after birth
Apgar score less than 7
Time Frame: at 1 and 5 minutes after birth

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
Rate of serious neonatal morbidity or death
Time Frame: within 28 days of birth
within 28 days of birth
Cord arterial plasma liquid chromatography mass spectrometry analysis
Time Frame: within 30 to 60 seconds of birth
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Principal Investigator: Yunhai Chuai, Dr, Sixth Medical Center, Chinese PLA General Hospital
  • Principal Investigator: Fang Chuai, Sixth Medical Center, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYH002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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