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Thromb Haemost 2000; 84(04): 583-590
DOI: 10.1055/s-0037-1614071
Review Article
Schattauer GmbH

Antithrombin Therapy for Severe Preeclampsia

Results of a Double-blind, Randomized, Placebo-controlled Trial
Masahiro Maki
1   From the Department of Obstetrics & Gynecology, Akita University School of Medicine, Akita, Japan
,
Takao Kobayashi
2   Department of Obstetrics & Gynecology, Hamamatsu University School of Medicine, Shizuoka, Japan
,
Toshihiko Terao
2   Department of Obstetrics & Gynecology, Hamamatsu University School of Medicine, Shizuoka, Japan
,
Tsuyomu Ikenoue
3   Department of Obstetrics & Gynecology, Miyazaki Medical College, Miyazaki, Japan
,
Kazuo Satoh
4   Department of Obstetrics & Gynecology, Nihon University School of Medicine, Tokyo, Japan
,
Masao Nakabayashi
5   Department of Obstetrics & Gynecology, Tokyo Women’s Medical University, Tokyo, Japan
,
Yusuke Sagara
6   Department of Obstetrics & Gynecology, Kochi Medical School, Kochi
,
Yayoi Kajiwara
7   Drug Innovation & Approval, Aventis Pharma, Ltd., Tokyo, Japan
,
Masao Urata
7   Drug Innovation & Approval, Aventis Pharma, Ltd., Tokyo, Japan
,
for BI51.017 Study Group › Author Affiliations
Further Information

Publication History

Received 17 December 1999

Accepted after resubmission 18 April 2000

Publication Date:
11 December 2017 (online)

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Summary

A double-blind, randomized, placebo-controlled trial was conducted to evaluate whether treatment with Antithrombin (AT) concentrates improved the clinical and perinatal outcome in patients with severe preeclampsia. Severe preeclamptic patients (24 to 35 weeks of gestation, Gestosis Index (GI) > 6 points) were randomized into two groups: 66 received AT and 67 received placebo. There were no statistical differences in the clinical profiles of the two groups. Study drugs were given intravenously once daily for 7 consecutive days. Maternal symptoms were evaluated from the difference of GI between before and after treatment, and fetal findings were evaluated from the changes of the biophysical profile score and the estimated fetal weight gain. Improvement was significantly greater in the AT group for both the GI (p = 0.020) and the estimated fetal weight gain (p = 0.029). The improvement of coagulation parameters was also evaluated. The D-dimer levels increased significantly in the placebo group (p = 0.026), but did not change in the AT group. Gestation was significantly prolonged (p = 0.007), and the number of low-birth weight infants was significantly smaller (p = 0.011) in the AT group. No adverse events related to AT were observed. It is revealed that AT concentrate therapy for preeclampsia is effective and safe, leading to an improved perinatal outcome.

Key words

Preeclampsia - hypercoagulable state - vasoconstriction - antithrombin (AT) concentrate - low-birth weight infant

* The members of BI51.017 study group are listed in the Appendix, on pp. 588–9.


 

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