Prevention Of Hemolytic Anemia Of The Fetus Using A Novel Intravenous Infusion
Posted Date: Jul 5, 2019
- Investigator: Kara Markham
- Type of Study: Drug
The purpose of this research study is to measure how well and how safe M281 is in treating patients with Hemolytic Disease of the Fetus and Newborn (HDFN). M281 is an investigational drug. Investigational means that the drug has not been approved by the regulatory authorities in the United States. You are being asked to consider your baby participating in this study because of your history of HDFN onset earlier than 24 weeks (gestational age) in your previous pregnancy, thus increasing your risk for developing HDFN in the current pregnancy. It is up to you to decide if you wish for your baby to participate. Before you decide whether or not your baby will take part in this study, we would like to explain why the research is being done and what it would involve for your baby. Your study doctor or member of the study staff will go through this consent form with you and answer any questions you might have. Ask the study doctor or member of the study staff if there is anything you do not understand. Talk to others about the study if you wish. If you agree for your baby to take part, you will be asked to sign and date the Consent Form. You are free to withdraw your baby at any time, without giving a reason. If you decide to stop your baby’s participation in the study, we encourage you to talk to the researcher and your regular doctor first so that stopping can be done safely. Another reason to tell your study doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful to your baby. This will not affect the standard of care your baby receives.
Women May Be Eligible If They Are Currently Pregnant With A History Of A Prior Pregnancy Complicated By Severe Hemolytic Disease Of The Fetus Diagnosed At Less Than 24 Weeks Of Gestation.
Hemolytic Anemia, Intrauterine Transfusion, Pubs
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