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Obstetrics & Gynecology 2007;110:249-255
© 2007 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Antepartum Treatment Without Early Cordocentesis for Standard-Risk Alloimmune Thrombocytopenia

A Randomized Controlled Trial

Richard L. Berkowitz, MD1, Martin L. Lesser, PhD2, Janice G. McFarland, MD3, Megan Wissert, RN4, Andrea Primiani4, Crystal Hung4 and James B. Bussel, MD4

From the 1Department of Obstetrics and Gynecology, Columbia Presbyterian Medical Center, New York, New York; 2Biostatistics Unit, Feinstein Institute for Medical Research, North Shore–LIJ Health System, New York, New York; the 3Blood Center of Wisconsin, Milwaukee, Wisconsin; and the 4Division of Hematology-Oncology, Department of Pediatrics, Weill Medical College of Cornell University, New York, New York.

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/mL3 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/mL3 and 116,100/mL3, and the average birth platelet counts were 169,400/mL3 and 134,000/mL3 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/mL3. 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.

CONCLUSION: 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.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00194987

LEVEL OF EVIDENCE: I






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