Antepartum treatment without early cordocentesis for standard-risk alloimmune thrombocytopenia: a randomized controlled trial.
OBJECTIVE
To evaluate the effectiveness and safety of two antenatal treatment regimens designed to optimally protect fetuses against intracranial hemorrhage resulting from alloimmune thrombocytopenia while minimizing the risks associated with fetal blood sampling. The study was limited to "standard-risk" patients, who were defined as women with documented alloimmune thrombocytopenia who had not delivered an infant with an intracranial hemorrhage in a prior pregnancy.


METHODS
In this prospective multicenter study of 73 women with documented alloimmune thrombocytopenia, patients were randomized to receive either intravenous immunoglobulin (IVIG) 2 g/kg/wk (group A) or IVIG 1 g/kg/wk plus prednisone 0.5 mg/kg/d (group B), starting at approximately 20 weeks of gestation. Fetal blood sampling was performed at approximately 32 weeks of gestation, and those with fetal platelet counts less than 30,000/mL(3) were given salvage therapy.


RESULTS
There were two intracranial hemorrhages; neither was due to treatment failure. The average platelet counts at the time of fetal blood sampling were 121,600/mL(3) and 116,100/mL(3), and the average birth platelet counts were 169,400/mL(3) and 134,000/mL(3) for groups A and B, respectively. Twenty-seven percent of patients in group A and 17% in group B received salvage therapy, and only one neonate in each of these subsets had a birth platelet count less than 30,000/mL(3). There were four complications after 79 fetal blood sampling procedures, leading to cesarean deliveries between 32 and 37 weeks. There was a higher incidence of gestational diabetes and a tendency to more fluid retention, mood swings, insomnia, and jitteriness in patients on prednisone and of moderate-to-severe fatigue in those on high-dose IVIG alone.


CONCLUSIONS
The outcomes of both treatment groups were excellent and comparable. Early cordocentesis is not necessary when treating alloimmune thrombocytopenia in patients who have not delivered an infant with an intracranial hemorrhage in a prior pregnancy.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00194987


METHODS
I.
Berkowitz
Richard L
RL
Department of Obstetrics and Gynecology, Columbia Presbyterian Medical Center, 622 West 168th Street, New York, NY 10032, USA. rb2212@columbia.edu
Lesser
Martin L
ML
McFarland
Janice G
JG
Wissert
Megan
M
Primiani
Andrea
A
Hung
Crystal
C
Bussel
James B
JB
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D016824:Antigens, Human Platelet / Q000276:immunology; D017218:Cordocentesis / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D005312:Fetal Blood / Q000166:cytology / Q000187:drug effects; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage*; D020300:Intracranial Hemorrhages / Q000517:prevention & control*; D010976:Platelet Count; D011241:Prednisone / Q000008:administration & dosage*; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000188:drug therapy / Q000276:immunology; D011256:Pregnancy Outcome; D011446:Prospective Studies; D013921:Thrombocytopenia / Q000188:drug therapy / Q000276:immunology
D000893:Anti-Inflammatory Agents; D016824:Antigens, Human Platelet; D004338:Drug Combinations; D016756:Immunoglobulins, Intravenous; D011241:Prednisone