Clinical trial NCT05345561: Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
Official title: A Prospective, Natural History Study to Assess the Occurrence of HPA-1a Alloimmunization in Women Identified at Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fetal and Neonatal Alloimmune Thrombocytopenia
Keywords: Alloimmunization
HPA-1a
Fetal and Neonatal Alloimmune Thrombocytopenia
Neonatal thrombocytopenia
Pregnant women
Lead sponsor: Rallybio
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 30000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women presenting at a Gestation Week 10 to 14 pre-natal visit

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women (≥ 18 years of age) who have provided informed consent for the study.

Exclusion Criteria:

* Participants with prior history of FNAIT

Primary outcomes:
measure: Number of participants with higher FNAIT risk characterized by race and ethnicity
timeFrame: At inclusion
Secondary outcomes:
measure: Frequency of anti-HPA-1a maternal alloimmunization
timeFrame: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
measure: Pregnancy outcomes: incidence of live births, spontaneous abortion, elective abortion, still birth, and premature birth
timeFrame: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
measure: Occurrence of neonatal thrombocytopenia
timeFrame: At birth or at the time of the pregnancy terminating event
Other outcomes:
Locations:
city: Chandler
country: United States
facility: New Horizons Clinical Trials, LLC
state: Arizona
city: Gardena
country: United States
facility: Zillan Clinical Research - Gardena
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: New Brunswick
country: United States
facility: St. Peter's University Hospital
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian-Queens
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine-New York Presbyterian Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Dayton
country: United States
facility: Wright State Physicians Obstetrics & Gynecology
state: Ohio
city: Philadelphia
country: United States
facility: Temple Perinatal Diagnosis Center
state: Pennsylvania
city: Dallas
country: United States
facility: Javara Inc. - Forest
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Javara Research Inc. - Dallas - PPDS
state: Texas
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Jena
country: Germany
facility: Klinikum der Friedrich Schiller Universität Jena
state: Thüringen
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-Holland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Ullevål
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord Norge
city: Lund
country: Sweden
facility: Barnmorskestationen Rosengård
state: Skane
city: Stockholm
country: Sweden
facility: Södersjukhuset
state: Stockholms Ian
city: Uppsala
country: Sweden
facility: Clinical Trial Consultants - Uppsala
state: Uppsala Ian
city: London
country: United Kingdom
facility: St. Thomas' Hospital
state: Surrey
Study officials:
References: