Clinical trials help researchers build scientific knowledge that supports the development of future treatments, even when a study does not achieve the expected outcome.
Taking part in a clinical trial is usually an unfamiliar experience, especially when you have a rare condition such as fetal and neonatal alloimmune thrombocytopenia (FNAIT), and you may not know other people who have participated in one.
Understanding what happens before, during and after a clinical trial can make the process easier to navigate. Here is what you can expect if you are considering taking part.
Sign up here to get the latest news, perspectives, and information about FNAITFetal and neonatal alloimmune thrombocytopenia A rare condition in which a mother’s immune system attacks fetal platelets, leading to dangerously low platelet levels before and/or after birth. sent directly to your inbox. Registration is free and only takes a minute.
Who can participate in an FNAIT clinical trial?
Eligibility is based on factors such as pregnancy history and specific blood test results, which vary according to the treatment being studied. FNAIT trials generally focus on pregnancies in which the fetus is at increased risk of the condition.
For example, in the FREESIA-1 trial, the eligibility criteria include a previous FNAIT-affected pregnancy and specific maternal antibody and fetal platelet-antigen findings.
Before enrollment, the research team reviews your medical and pregnancy history and performs screening tests. You should also receive information about the study, including its potential risks and benefits, before providing informed consent. Participation is voluntary, and you can leave a clinical trial after enrolling if you change your mind.
What happens during the trial?
Once enrolled, you will have scheduled study visits during pregnancy. The number and timing of visits depend on the study protocol.
Treatment trials for FNAIT often begin during pregnancy. The research team will explain the possible treatment groups and how you will be assigned to one of them. Some trials are blinded, meaning you won’t know which treatment you are receiving until the study is completed.
Read more about FNAIT therapies
How is safety monitored?
In studies involving pregnant participants, safety monitoring is especially important because researchers need to consider how the treatment could affect both the participant and the developing baby. They monitor both throughout the study for side effects and other pregnancy-related outcomes.
You may have additional blood tests, physical assessments or fetal monitoringFetal monitoring Can include Ultrasounds, Doppler studies and other evaluations that help the care team track fetal health and watch for potential complications. depending on the study. Before enrolling, the research team should explain the known and potential risks of the treatment and what will happen if a safety concern arises.
What happens when the baby is born?
Monitoring continues after delivery. For example, in the FREESIA-3 trial, each baby’s platelet countPlatelet count A measure of how many platelets are in the blood. FNAIT is characterized by severely reduced counts in a fetus or newborn. was checked at birth, and the infants were monitored for serious FNAIT-related symptoms, including bleeding and the need for platelet transfusions.
Monitoring after delivery can continue for weeks or longer.
What about costs?
Ask which costs the study will cover before enrolling. ClinicalTrials.gov notes that many trials pay for study-related treatment, tests and visits, while participants or their insurance are still responsible for routine medical care. Travel or lodging can also be covered.
What should you know before joining?
Before enrolling, here are some questions you can ask the study team:
- Will I know which treatment I am receiving?
- What are the known and potential risks?
- What tests and procedures will I need?
- How often will I need to attend study visits?
- How will my baby’s health be monitored?
- What happens if I have a health problem or there is a concern about my baby?
- How long will follow-up continue?
If you are interested in a clinical trial, you can search for FNAIT studies through ClinicalTrials.gov and discuss participation with your healthcare provider. Study eligibility and availability can change, so check the individual trial record for the most up-to-date information.
