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Maternal Hyperoxygenation for Left Heart Hypoplasia (MHO Trial)
N/A
Waitlist Available
Led By Shaine A Morris, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group D: Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and any of the following: Any mitral annulus, aortic annulus, left ventricular end-diastolic dimension, or aortic diameter z-score less than or equal to 2.0; Right-left ventricular size discrepancy with no other explanation of discrepancy; Continuous Doppler flow in the aortic arch concerning for coarctation; Significantly less aortic flow than pulmonary artery flow; Severe atrial septal aneurysm with possible obstruction of mitral valve flow; Left superior vena cava to coronary sinus with dilated coronary sinus; Retrograde blood flow in the aortic arch from the ductus arteriosus; Hypoplastic left heart syndrome (HLHS) and variants of HLHS; Total anomalous pulmonary venous return
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years
Awards & highlights
MHO Trial Summary
This trial tested a new type of treatment that could help infants with LHH.
Who is the study for?
This trial is for pregnant women with normal ultrasounds or those whose fetuses have specific heart issues like left heart hypoplasia, at risk of aortic coarctation, or related conditions. It's not for mothers with multiple pregnancies, certain health problems (like severe hypertension), or poor ultrasound images.Check my eligibility
What is being tested?
The study tests if giving extra oxygen to the mother can help babies who might be born with small left-sided heart structures. Mothers breathe in more oxygen and doctors check if it improves the baby's heart condition before birth.See study design
What are the potential side effects?
While maternal hyperoxygenation is generally considered safe, potential side effects are not detailed here. Typically, increased oxygen levels could lead to changes in blood flow or oxidative stress but would be closely monitored.
MHO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My fetus has a heart condition affecting the left side or aorta.
MHO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aortic annular dimension
Secondary outcome measures
Mitral annular dimension
MHO Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Chonic Maternal Hyperoxygenation w/ LHHExperimental Treatment1 Intervention
Mothers who have a fetus diagnosed with LHH and elect daily maternal hyperoxygenation therapy.
Group II: Acute Maternal Hyperoxygenation with LHHExperimental Treatment1 Intervention
Mothers who have a fetus diagnosed with LHH and elect acute maternal hyperoxygenation challenge testing.
Group III: Historical LHH ControlsActive Control1 Intervention
Previous women with a dx of fetal LHH and whose care was continued at Texas Children's Hospital.
Group IV: Healthy Fetal ControlsPlacebo Group1 Intervention
Healthy mothers with healthy fetuses that will come in monthly for fetal echcos starting at 20 wks.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,155 Total Patients Enrolled
Shaine A Morris, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition during pregnancy that could affect my baby's heart and blood flow.My fetus has a heart condition affecting the left side or aorta.My cancer cells have an abnormal number of chromosomes.I have a constant irregular heartbeat.My fetus has a heart condition with specific measurements and blood flow issues.
Research Study Groups:
This trial has the following groups:- Group 1: Chonic Maternal Hyperoxygenation w/ LHH
- Group 2: Acute Maternal Hyperoxygenation with LHH
- Group 3: Healthy Fetal Controls
- Group 4: Historical LHH Controls
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots left for applicants to join this research?
"The information hosted on clinicaltrials.gov suggests that this medical trial is not currently seeking participants, with its last update occuring on the 8th of September 2023. However, there are 1 other trials actively recruiting at this time."
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