Alloimmune Thrombocytopenia, Fetal Alloimmune Thrombocytopenia
Conditions
Keywords
Alloimmune thrombocytopenia, Fetal alloimmune thrombocytopenia
Brief 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).
Interventions
one gram per kg of IVIG per infusion given either once or twice
DRUGprednisone
in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day
Sponsors
New York Presbyterian Hospital
Columbia University
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
participants and their physicians will know if they are receiving IVIG x 2 or IVIG x1 plus prednisone
Intervention model description
randomization between 2 groups
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Newborns With a Birth Platelet Count > 50,000/uL | 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40 | this uses the birth platelet count of the fetuses from the study when they are born |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study | time of ICH (range 20-40 wks) | number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation |
| Number of Fetal Platelet Counts > 50,000/uL | 32 +/- 2 weeks | Number of Fetal Platelet Counts \> 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined |
Countries
United States
Participant flow
Recruitment details
pregnant women with a fetus affected by FNAIT were enrolled at multiple sites with local IRB permission and local consents fetuses were tracked in utero and after birth for 2 weeks
Participants by arm
| Arm | Count |
|---|---|
| IVIG (Intravenous Gamma Globulin) 2g/kg/Week pregnant women with alloimmune thrombocytopenia and a previous affected fetus/newborn and a current affected fetus starting IVIG 2 g/kg/week | 51 |
| IVIG 1g/kg/wk and Prednisone 0.5mg/kg/Day pregnant women with alloimmune thrombocytopenia and a previous affected fetus/newborn and a current affected fetus starting IVIG 1 g/kg/week + prednisone 0.5mg/kg/day | 51 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | IVIG (Intravenous Gamma Globulin) 2g/kg/Week | IVIG 1g/kg/wk and Prednisone 0.5mg/kg/Day | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 51 Participants | 102 Participants |
| Region of Enrollment Canada | 3 participants | 5 participants | 8 participants |
| Region of Enrollment United States | 48 participants | 46 participants | 94 participants |
| Sex: Female, Male Female | 51 Participants | 51 Participants | 102 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 12 / 51 | 8 / 51 | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 14 / 51 | 12 / 51 | 4 / 51 | 3 / 51 |
Outcome results
Primary
Number of Newborns With a Birth Platelet Count > 50,000/uL
this uses the birth platelet count of the fetuses from the study when they are born
Time frame: 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IVIG 1g/kg Twice Per Week | Number of Newborns With a Birth Platelet Count > 50,000/uL | 48 number of newborns with >50,000 pets |
| IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day | Number of Newborns With a Birth Platelet Count > 50,000/uL | 47 number of newborns with >50,000 pets |
Secondary
Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study
number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation
Time frame: time of ICH (range 20-40 wks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IVIG 1g/kg Twice Per Week | Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study | 0 number of newborns with ICH |
| IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day | Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study | 0 number of newborns with ICH |
Secondary
Number of Fetal Platelet Counts > 50,000/uL
Number of Fetal Platelet Counts \> 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined
Time frame: 32 +/- 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IVIG 1g/kg Twice Per Week | Number of Fetal Platelet Counts > 50,000/uL | 44 number newborns with >50,000 pats |
| IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day | Number of Fetal Platelet Counts > 50,000/uL | 43 number newborns with >50,000 pats |