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Maternal Oxygen Administration for Fetal Distress

Primary Purpose

Oxygen Inhalation Therapy, Second Stage of Labour, Fetal Distress

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low flow nasal oxygen
Low flow room air
Sponsored by
Navy General Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxygen Inhalation Therapy

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynecology, Navy General Hospital.
  • Navy General Hospital
  • Department of Obstetrics and Gynecology, Navy General Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

air, second stage of labor

oxygen, second stage of labor

Arm Description

Patients randomized to the group will receive sham administered by nasal catheter. The therapy will continue until after delivery

Patients randomized to the group will receive oxygen administered by low flow nasal oxygen at a flow rate of 2 L/min. The therapy will continue until after delivery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
maternal radial arterial partial pressure of oxygen
Immediately after delivery (within 30-60 seconds of birth), radial artery blood gas sample will be obtained.
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.

Full Information

First Posted
August 16, 2014
Last Updated
May 21, 2020
Sponsor
Navy General Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02221440
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navy General Hospital, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Inhalation Therapy, Second Stage of Labour, Fetal Distress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
air, second stage of labor
Arm Type
Placebo Comparator
Arm Description
Patients randomized to the group will receive sham administered by nasal catheter. The therapy will continue until after delivery
Arm Title
oxygen, second stage of labor
Arm Type
Experimental
Arm Description
Patients randomized to the group will receive oxygen administered by low flow nasal oxygen at a flow rate of 2 L/min. The therapy will continue until after delivery
Intervention Type
Device
Intervention Name(s)
Low flow nasal oxygen
Intervention Description
Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery
Intervention Type
Device
Intervention Name(s)
Low flow room air
Intervention Description
Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.
Primary Outcome Measure Information:
Title
cord arterial pH values (hydrogen ion concentration) less than 7.2
Description
Immediately after delivery (within 30-60 seconds of birth), umbilical cord arterial blood gas sample will be obtained.
Time Frame
within 30-60 seconds of birth
Secondary Outcome Measure Information:
Title
Apgar score less than 7
Description
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.
Time Frame
at one and five minutes after birth
Title
maternal radial arterial partial pressure of oxygen
Description
Immediately after delivery (within 30-60 seconds of birth), radial artery blood gas sample will be obtained.
Time Frame
within 30-60 seconds of birth
Title
umbilical cord venous partial pressure of oxygen
Description
Immediately after delivery (within 30-60 seconds of birth), umbilical cord venous blood gas sample will be obtained.
Time Frame
within 30-60 seconds of birth
Other Pre-specified Outcome Measures:
Title
cesarean delivery rate
Time Frame
during the second stage of labor
Title
assisted vaginal delivery
Time Frame
during the second stage of labor
Title
maternal dissatisfaction
Time Frame
during the second stage of labor
Title
abnormal fetal heart rate tracing
Time Frame
during the second stage of labor
Title
neonatal resuscitation
Time Frame
within 10 mins of birth
Title
neonatal encephalopathy
Time Frame
within 24 hours of birth
Title
serious neonatal morbidity or death
Time Frame
within 28 days of birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunhai Chuai, Dr
Organizational Affiliation
Navy General Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Navy General Hospital.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Facility Name
Navy General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Facility Name
Department of Obstetrics and Gynecology, Navy General Hospital.
City
Beijing
ZIP/Postal Code
100048
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28224745
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.
Results Reference
result
PubMed Identifier
32887557
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.
Results Reference
derived

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Maternal Oxygen Administration for Fetal Distress

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