Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and… (NCT05345561) | Clinical Trial Compass
CompletedNot Applicable
Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
United States, Canada, Germany14,390 participantsStarted 2022-03-14
Plain-language summary
A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women (≥ 18 years of age) who have provided informed consent for the study.
Exclusion Criteria:
* Participants with prior history of FNAIT
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study focused on women at higher risk for FNAIT and looked at how race and ethnicity relate to that risk — does my own background or ethnicity put me in a group that should be screened or monitored more closely for HPA-1a alloimmunization?
2Since this trial has already been completed, has my doctor seen or reviewed any of its findings about who is most likely to develop FNAIT, and could those results change how my pregnancy is monitored?
3The study was measuring how often HPA-1a alloimmunization actually occurs in higher-risk women — based on that kind of data, should I be tested for HPA-1a antibodies, and what would a positive result mean for my baby's care plan?
4If I am identified as being at higher risk for FNAIT, what are the current standard-of-care options available to me now, and are there any newer trials or interventions my doctor would recommend based on what studies like this one have found?
5FNAIT can cause serious bleeding in newborns — if this completed study has helped clarify which women are most at risk, how does my doctor use that information to decide whether I need additional specialist referrals or fetal monitoring during my pregnancy?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with higher FNAIT risk characterized by race and ethnicity