Healthy Pregnant Women Needed for Research Study
What is the purpose of this study?
This is a research study to learn more about babies born with heart and lung disease by studying the effect of oxygen on the blood vessels of a baby’s lungs before birth.
The information gained from this study may help us identify those babies who need more urgent and critical care prior to their birth. This may enable us to advise their mothers how to plan ahead of time for the kind of care their baby may need.
Who can participate?Healthy pregnant women who are 18 years or older may be eligible to participate.
What is involved?
If you choose to participate, you will be in the research study for one study visit. The study visit will include a fetal echocardiogram (echo) and oxygen test.
A fetal echo is a test that will get an image of your baby’s heart using ultrasound. It is a safe procedure for both mother and baby and does not involve radiation exposure.
If you do decide to take part in this study, the study doctor or staff will have you come to Cincinnati Children’s when you are between 31 and 36 weeks of your pregnancy. You will undergo the fetal echo to make sure the baby’s heart is normal. Then, you will breathe in oxygen by mask for 10 minutes. After 10 minutes, a repeat, limited echo will be done. The echo results taken before you breathed in the oxygen will be compared to those after you breathed in the oxygen. The fetal echo and oxygen test will be done free of charge for research purposes only. The entire visit will last 60-90 minutes.
A detailed list of procedures will be provided to anyone interested in knowing more about this study.
What are the benefits?
You may or may not receive a direct medical benefit from being in this study. However, the information gained from this study may help researchers understand more about babies born with heart and lung disease in the future.
Will I get all the facts about the study?
You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the risks and discomforts of the study?
This is a minimal risk study but all possible discomforts or risks will be discussed with you if you are interested in learning more about the study.
Do participants receive pay, compensation or reimbursement?
Participants will not receive payment for this one-time study visit lasting 60 to 90 minutes. However, participants will receive a free fetal echo of their baby’s heart.