Maternal Oxygen Administration for Fetal Distress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oxygen Inhalation Therapy Second Stage of Labour Fetal Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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air, second stage of labor

Patients randomized to the group will receive sham administered by nasal catheter.

The therapy will continue until after delivery

Group Type PLACEBO_COMPARATOR

Low flow room air

Intervention Type DEVICE

Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.

oxygen, second stage of labor

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

Group Type EXPERIMENTAL

Low flow nasal oxygen

Intervention Type DEVICE

Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery

Interventions

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Low flow nasal oxygen

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

Low flow room air

Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes