Dataset Information

Pregnancy and Birth Outcomes among Women with Idiopathic Thrombocytopenic Purpura.

ABSTRACT:

Objective

To examine pregnancy and birth outcomes among women with idiopathic thrombocytopenic purpura (ITP) or chronic ITP (cITP) diagnosed before or during pregnancy.

Methods

A linkage of mothers and babies within a large U.S. health insurance database that combines enrollment data, pharmacy claims, and medical claims was carried out to identify pregnancies in women with ITP or cITP. Outcomes included preterm birth, elective and spontaneous loss, and major congenital anomalies.

Results

Results suggest that women diagnosed with ITP or cITP prior to their estimated date of conception may be at higher risk for stillbirth, fetal loss, and premature delivery. Among 446 pregnancies in women with ITP, 346 resulted in live births. Women with cITP experienced more adverse outcomes than those with a pregnancy-related diagnosis of ITP. Although 7.8% of all live births had major congenital anomalies, the majority were isolated heart defects. Among deliveries in women with cITP, 15.2% of live births were preterm.

Conclusions

The results of this study provide further evidence that cause and duration of maternal ITP are important determinants of the outcomes of pregnancy.

SUBMITTER: Wyszynski DF

PROVIDER: S-EPMC4820621 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

Pregnancy and Birth Outcomes among Women with Idiopathic Thrombocytopenic Purpura.

Wyszynski Diego F DF Carman Wendy J WJ Cantor Alan B AB Graham John M JM Kunz Liza H LH Slavotinek Anne M AM Kirby Russell S RS Seeger John J

Journal of pregnancy 20160322

<h4>Objective</h4>To examine pregnancy and birth outcomes among women with idiopathic thrombocytopenic purpura (ITP) or chronic ITP (cITP) diagnosed before or during pregnancy.<h4>Methods</h4>A linkage of mothers and babies within a large U.S. health insurance database that combines enrollment data, pharmacy claims, and medical claims was carried out to identify pregnancies in women with ITP or cITP. Outcomes included preterm birth, elective and spontaneous loss, and major congenital anomalies.< ...[more]

PMID: 27092275

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Project description:Background and objectivesThis multicentre, open-label study investigated the safety and efficacy of Gammaplex, a 5% Intravenous Immunoglobulin (IVIg), in patients with idiopathic (immune) thrombocytopenic purpura (ITP).Materials and methodsPatients were between the ages of 6 and 70 years; had ITP for at least six months and had a platelet count ≤ 20 × 10(9)/L. Eligible patients were dosed with 1 g/kg of Gammaplex on two consecutive days, followed by assessment of safety and efficacy on Days 3, 5, 9, 14, 21, 32 and 90. Response was defined as the increase in platelet count to a threshold of ≥ 50 × 10(9)/L on or before Day 9 after the first dose of Gammaplex.ResultsAll 35 patients received at least one infusion of Gammaplex. Twenty-nine (83%) patients responded to Gammaplex, similar to the historical control, with a 95% lower one-sided confidence interval of 68.9%. Median duration of response was 10.0 days, with an overall reduction in bleeding episodes. Gammaplex provided supranormal concentrations of total IgG; mean peak concentration (Cmax) of 45.3 g/L (4.53 g/dL), with a mean half-life of 28.5 days. Fifteen patients reported 63 Adverse Drug Reactions (ADRs); the most common were headache (10 patients), vomiting (6 patients) and pyrexia (5 patients). Five of these ADRs were considered serious, one patient had three concurrent Serious Adverse Events (SAEs); these were vomiting, dehydration and headache. Two other patients each had one SAE (headache). There were no unexpected Adverse Events (AEs) or thromboembolic episodes and no significant changes in vital signs, biochemical, haematological and virology results.ConclusionGammaplex achieved a very high concentration of serum IgG but was well-tolerated and effective in the treatment of ITP with a similar degree of efficacy to the pre-determined historical control group and the pre-set statistical criteria.Trial registrationClinicalTrials.gov NCT00504075 Clinical Trials Registry India 000016.

Dataset Information

Pregnancy and Birth Outcomes among Women with Idiopathic Thrombocytopenic Purpura.

Objective

Methods

Results

Conclusions

Publications

Pregnancy and Birth Outcomes among Women with Idiopathic Thrombocytopenic Purpura.

Similar Datasets

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