To inform the frequency of women at higher FNAIT risk among pregnant women of different racial and ethnic characteristics who present for pre-natal care and to assess the occurrence of HPA-1a alloimmunization in these women. It is planned that data…
ID
Source
Brief title
Condition
- Platelet disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective:
To inform the frequency of women at higher FNAIT risk among pregnant women of
different racial and ethnic characteristics who present for
pre-natal care.
Primary outcome:
The number of participants that are determined to be at higher FNAIT risk
compared to the total number of pregnant women assessed for higher
FNAIT risk, with attention to self-characterized race and ethnicity.
Secondary outcome
Secondary objectives:
* To inform the frequency of human platelet antigen (HPA)-1a alloimmunization
among pregnant women identified at higher FNAIT risk.
* To inform the frequency of pregnancy outcomes among pregnant women identified
at higher FNAIT risk
* To inform the frequency, where data are available, of neonatal
thrombocytopenia in infants born to women who have alloimmunized, as determined
by detectable anti-HPA-1a antibody at Week 10 postpartum
Secondary outcomes:
* Occurrence of anti-HPA-1a maternal alloimmunization at Week 10 postpartum
* Rate of spontaneous abortion, defined as non-deliberate fetal death which
occurs prior to 19 weeks of gestation
• Rate of elective abortion, defined as deliberate termination of pregnancy
at any time in gestation
• Rate of still birth, defined as non-deliberate fetal death anytime in
gestation on or after 19 weeks of gestation
• Rate of premature delivery, defined as live birth prior to 37 completed
weeks of gestation
• Rate of live births (>= 37 completed weeks of gestation)
* Neonatal thrombocytopenia, as determined by a platelet count < 50 × 109/L
within 72 hours of birth, where data are available
Background summary
Of the approximately 2% of Caucasian pregnant women who are HPA-1a negative
(ie, HPA-1b/b), approximately 85% will be carrying an HPA-1a positive fetus.
Overall, approximately 10% of these pregnant women will become alloimmunized
and among the fetuses or neonates of lloimmunized women, about 10% will have
severe thrombocytopenia (50 x 109/L; < 50,000 platelets/mL)), many with
bleeding sequelae; about 1% of the incompatible fetuses or neonates will suffer
intracranial hemorrhage. Among the women who become alloimmunized, 90%-98% will
come from among the approximately 27% who are HLA-DRB3*01:01 positive, meaning
that those women with this HLA allele face an alloimmunization risk of
approximately 25%-30%, vs 1% to 2% for those without the allele. Human platelet
antigen genotype frequencies vary by race, and an alloimmune response to
HPA-1a, the immunodominant platelet antigen in Caucasians (~75% to 80% of
cases), is implicated in the majority of FNAIT cases (ie, in HPA-1bb homozygous
pregnant women exposed to fetal platelets expressing HPA-1a derived from a
HPA-1a positive father). Data reporting on the frequency of the HPA-1b/b
genotype in non-Caucasian populations is limited, with reports showing a lower
frequency in African populations and in Asians. Data reporting on the
frequency of a population reporting Hispanic ethnicity are sparse. Data from
this study will inform the frequency of women at higher FNAIT risk among
pregnant women of different racial and ethnic characteristics obtaining
pre-natal care at the involved institutions and consenting for the study and
will assess the occurrence of HPA-1a alloimmunization in these women. It is
planned that data from this study be used as an external control for a future
single arm registration study of an anti-HPA-1a antibody therapeutic for the
prevention of FNAIT.
Study objective
To inform the frequency of women at higher FNAIT risk among pregnant women of
different racial and ethnic characteristics who present for pre-natal care and
to assess the occurrence of HPA-1a alloimmunization in these women. It is
planned that data from this study be used as an external control for a future
single arm registration study of an anti-HPA-1a antibody therapeutic for the
prevention of FNAIT.
Study design
This is a prospective, non-interventional, natural history study into FNAIT.
Study burden and risks
This is a low-risk study: in the vast majority of cases, an extra tube of blood
will be taken from women during a regular venipuncture. In a (very) small
number of cases, there will be an increased risk of FNAIT and an extra tube of
blood will be taken as part of a study. Being aware of an increased risk of
FNAIT can be a psychological burden.
234 Church Street, Suite 1020 1020
New Haven, US CT 06510
US
234 Church Street, Suite 1020 1020
New Haven, US CT 06510
US
Listed location countries
Inclusion criteria
Pregnant women (>= 18 years of age) who have provided informed consent for the
study.
Exclusion criteria
Prior history of FNAIT
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78636.058.21 |