Maternal Hyperoxygenation in Congenital Heart Disease

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

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-02

Study Completion Date

2024-03-22

Brief Summary

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A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease

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Detailed Description

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The aim of the study is to investigate the safety and feasibility of chronic maternal hyperoxygenation in pregnancies affected by fetal congenital heart disease, specifically those pregnancies in which the fetus has single ventricle physiology with aortic arch obstruction. The treatment has a potentially neuroprotective effect on the fetus. This would be desirable as the neurodevelopmental outcomes of the survivors of this form of congenital heart disease are significantly below normal. However, transplacental oxygen has not been tried in this setting, and so before embarking on a trial, the investigators need to establish that the treatment is safe and feasible. This will be accomplished by recruiting subjects which meet the eligibility criteria and commence treatment at the time of diagnosis, usually in the second trimester, and by comparing outcomes with a historical cohort with CHD diagnoses with no oxygen intervention. The oxygen will be delivered to the mother via nasal prongs continuously at a rate of up to 4 L/min. Oxygen concentrators will be supplied to the subjects' homes, and a range of portable devices will also be provided to allow them to continue with usual activities of daily living. A series of follow up appointments will be arranged to check the status of the mother and fetus. Mothers will be invited to keep a diary of their adherence to the treatment. A range of routine clinical and research data on the condition of the fetus and newborn will be collected.

Conditions

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Hypoplastic Left Heart Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pilot

Maternal Hyperoxygenation (4L/min via nasal prongs)

Group Type EXPERIMENTAL

Maternal Hyperoxygenation

Intervention Type DRUG

Oxygen via nasal prongs at up to 4L/min continuously during 2nd and 3rd trimester of pregnancy until birth

Interventions

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Maternal Hyperoxygenation

Oxygen via nasal prongs at up to 4L/min continuously during 2nd and 3rd trimester of pregnancy until birth

Intervention Type DRUG

Other Intervention Names

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Oxygen

Eligibility Criteria

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Inclusion Criteria

* Between 20-32 weeks gestation
* Diagnosis of fetus with a single ventricular ventricular heart
* Delivering at Mount Sinai Hospital
* Written informed consent

Exclusion Criteria

* Opting for termination of pregnancy/ comfort care
* Normal exclusions for MRI (e.g. claustrophobia, cardiac pacemaker, etc.)
* BMI \>37.0
* Infections/ anemia
* Smoker
* Serious cardiorespiratory co-morbidities

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No