Document Detail


Antepartum treatment without early cordocentesis for standard-risk alloimmune thrombocytopenia: a randomized controlled trial.
MedLine Citation:
PMID:  17666597     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. 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.
Authors:
Richard L Berkowitz; Martin L Lesser; Janice G McFarland; Megan Wissert; Andrea Primiani; Crystal Hung; James B Bussel
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  110     ISSN:  0029-7844     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2007 Aug 
Date Detail:
Created Date:  2007-08-01     Completed Date:  2007-08-30     Revised Date:  2009-10-26    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  249-55     Citation Subset:  AIM; IM    
Affiliation:
Department of Obstetrics and Gynecology, Columbia Presbyterian Medical Center, 622 West 168th Street, New York, NY 10032, USA. rb2212@columbia.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00194987
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Inflammatory Agents / administration & dosage*
Antigens, Human Platelet / immunology
Cordocentesis / adverse effects
Drug Combinations
Female
Fetal Blood / cytology,  drug effects
Humans
Immunoglobulins, Intravenous / administration & dosage*
Intracranial Hemorrhages / prevention & control*
Platelet Count
Prednisone / administration & dosage*
Pregnancy
Pregnancy Complications, Hematologic* / drug therapy,  immunology
Pregnancy Outcome
Prospective Studies
Thrombocytopenia* / drug therapy,  immunology
Chemical
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Antigens, Human Platelet; 0/Drug Combinations; 0/Immunoglobulins, Intravenous; 53-03-2/Prednisone

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