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| Name | Class |
|---|---|
| New York Presbyterian Hospital | OTHER |
| Columbia University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG x 2 | Experimental | IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT |
|
| IVIG x 1 + prednisone | Experimental | IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG (Intravenous Immunoglobulin) | Drug | one gram per kg of IVIG per infusion given either once or twice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of ICH (range 20-40 wks) |
| Number of Fetal Platelet Counts > 50,000/uL |
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Inclusion Criteria:
Pregnant women are eligible for inclusion into the Very High Risk Group if they:
Pregnant women are eligible for inclusion into the High Risk Group if they:
Pregnant women are eligible for inclusion into the Standard Risk Group if they:
Exclusion Criteria:
Women are not eligible for inclusion into the Very High Risk Group if they:
Women are not eligible for inclusion into the High Risk Group if they:
Women are not eligible for inclusion into the Standard Risk Group if they:
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| Name | Affiliation | Role |
|---|---|---|
| James B Bussel, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital-Weill Cornell Medical Center | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27611703 | Derived | Lakkaraja M, Jin JC, Manotas KC, Vinograd CA, Ferd P, Gabor J, Wissert M, Berkowitz RL, McFarland JG, Bussel JB. Blood group A mothers are more likely to develop anemia during antenatal intravenous immunoglobulin treatment of fetal and neonatal alloimmune thrombocytopenia. Transfusion. 2016 Oct;56(10):2449-2454. doi: 10.1111/trf.13779. Epub 2016 Sep 9. | |
| 17666597 |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Gammglobulin (IVIG) 1g/kg Twice Per Week | 51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was < 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered |
| FG001 | IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day | IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was < 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be > 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
study describes pregnant women who are receiving treatment but also fetuses and then newborns
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | IVIG 1g/kg/wk and Prednisone 0.5mg/kg/Day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | number of newborns with >50,000 pets | 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 |
|
collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVIG X 2 Weekly | Intravenous Immunoglobulin (IVIG) one gram per kg bodyweight infused twice weekly to mothers during pregnancy fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| preterm labor | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| jaw tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | past history |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr James Bussel | Weill MC | 917-291-5091 | jbussel@med.cornell.edu |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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randomization between 2 groups
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participants and their physicians will know if they are receiving IVIG x 2 or IVIG x1 plus prednisone
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| prednisone | Drug | in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day |
|
Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined |
| 32 +/- 2 weeks |
| Berkowitz RL, Lesser ML, McFarland JG, Wissert M, Primiani A, Hung C, Bussel JB. Antepartum treatment without early cordocentesis for standard-risk alloimmune thrombocytopenia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):249-55. doi: 10.1097/01.AOG.0000270302.80336.dd. |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day | IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was < 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be > 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered |
|
|
| 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 | Posted | Number | number of newborns with ICH | time of ICH (range 20-40 wks) |
|
|
|
| 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 | Posted | Number | number newborns with >50,000 pats | 32 +/- 2 weeks |
|
|
|
| 0 |
| 51 |
| 14 |
| 51 |
| 12 |
| 51 |
| EG001 | IVIG 1 g/kg/wk + Prednisone | intravenous gammaglobulin 1 g/kg/wk infused once weekly to mother and prednisone 0.5 mg/kg/day taken by mothers during pregnancy and then tapered after birth fo newborn fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth | 0 | 51 | 12 | 51 | 8 | 51 |
| EG002 | IVIG X 2 Weekly--fetuses/Newborns | fetuses and newborns of mother receiving IVIG x 2 weekly | 0 | 51 | 4 | 51 | 0 | 51 |
| EG003 | IVIG x 1 + Prednisone---fetuses/Newborns | fetuses and newborns of mother receiving IVIG x 1 weekly + prednisone 0.5mg/kg daily | 0 | 51 | 3 | 51 | 0 | 51 |
| headache | Nervous system disorders | Non-systematic Assessment | 1 aseptic meningitis |
|
| amnionitis | Infections and infestations | Non-systematic Assessment |
|
| gestational diabetes | Endocrine disorders | Non-systematic Assessment | requiring hospitalization |
|
| HELLP | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | hypertension liver low platelets |
|
| thrombosis, venous | Blood and lymphatic system disorders | Non-systematic Assessment | Peripheral Intravenous Catheter thrombosis |
|
| depression | Psychiatric disorders | Non-systematic Assessment |
|
| diabetes mellitus | Endocrine disorders | Non-systematic Assessment |
|
| fetal ICH | Nervous system disorders | Systematic Assessment | Intracranial hemorrhage occurring in fetus |
|
| premature delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | delivery prior to 35 weeks of gestation |
|
| neonatal sepsis | Infections and infestations | Non-systematic Assessment | sepsis in newborn |
|
|
| IVIG dose error | Product Issues | Non-systematic Assessment | once each: 10 grams and 120 grams |
|
| hypertension | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| bells palsy | Nervous system disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| diabetes mellitus | Endocrine disorders | Non-systematic Assessment |
|
| neonatal hypoglycemia | Endocrine disorders | Non-systematic Assessment | low blood sugar in newborn |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |