Phase 3 N=102 Randomized Treatment

A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Alloimmune Thrombocytopenia · Fetal Alloimmune Thrombocytopenia

Bottom Line

View on ClinicalTrials.gov: NCT00194987 ↗

Enrolled (actual)

102

Serious AEs

16.2%

Results posted

Nov 2018

Primary outcome: Primary: Number of Newborns With a Birth Platelet Count > 50,000/uL — 48; 47 number of newborns with >50,000 pets

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: IVIG (Intravenous Immunoglobulin) (Drug); prednisone (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Weill Medical College of Cornell University
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Newborns With a Birth Platelet Count > 50,000/uL	48; 47	—
SECONDARY Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study	0; 0	—
SECONDARY Number of Fetal Platelet Counts > 50,000/uL	44; 43	—

Summary

The purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).

Eligibility Criteria

Inclusion Criteria

Pregnant women are eligible for inclusion into the Very High Risk Group if they:

are PLA-1 (platelet antigen A1) negative and have known platelet incompatibility with their fetus
have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation (as best as could be estimated)
are less than 19 weeks gestation

Pregnant women are eligible for inclusion into the High Risk Group if they:

are PLA-1 negative and have known platelet incompatibility with the fetus
have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation (as best as could be estimated)
are between 12-30 weeks gestation

Pregnant women are eligible for inclusion into the Standard Risk Group if they:

are PLA-1 negative and have known platelet incompatibility with the fetus
have not had a previous child who suffered an antenatal hemorrhage
are between 20-30 weeks gestation

Exclusion Criteria

Women are not eligible for inclusion into the Very High Risk Group if they:

have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation
are greater than 19 weeks gestation

Women are not eligible for inclusion into the High Risk Group if they:

have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation
are greater than 30 weeks gestation

Women are not eligible for inclusion into the Standard Risk Group if they:

have had a previous child who suffered an antenatal hemorrhage
are greater than 30 weeks gestation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00194987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.