Hiroshi Sameshima1, Yuki Kodama, Tsuyomu Ikenoue, Yayoi Kajiwara. 1. Department of Obstetrics and Gynecology and Perinatal Center, Faculty of Medicine, University of Miyazaki, Kiyotake, Miyazaki, Japan. hsameshima@fc.miyazaki-u.ac.jp
Abstract
AIM: To see if antithrombin (AT) supplementation improved fetal outcomes in early onset (<32 weeks) severe pre-eclampsia. METHODS: A subgroup re-analysis of an original randomized controlled trial of AT in pre-eclampsia between 24 and 35 weeks of gestation was performed. Either AT (3000 IU/day, n=42) or placebo (Albumin 582 mg/day, n=42) were administered for 7 days. Fetal weight gain, biophysical profile score and fetal heart rate monitoring were evaluated during the treatment week and until delivery. Comparisons were performed by intent-to-treat and relative risk (RR) and 95% Confidence Intervals (CI) were obtained. RESULTS: In each group, 27 women (64%) completed the allocated intervention. AT significantly decreased the worsening of the fetal biophysical profile score or fetal heart rate monitoring (RR 0.24, 95% CI 0.07-0.8), increased the incidence of estimated weight gain >15 g/day during the intervention week (3.1, 1.0-9.9), and prolonged gestational age to >or= 34 weeks (3.6, 1.05-12.6), however infant mortality rates did not differ between the two groups. No adverse events related to AT were observed. CONCLUSIONS: Supplementation of AT preserves fetal biophysical condition and weight gain in early onset severe pre-eclampsia and most likely prolongs pregnancies >or= 34 weeks of gestation.
RCT Entities:
AIM: To see if antithrombin (AT) supplementation improved fetal outcomes in early onset (<32 weeks) severe pre-eclampsia. METHODS: A subgroup re-analysis of an original randomized controlled trial of AT in pre-eclampsia between 24 and 35 weeks of gestation was performed. Either AT (3000 IU/day, n=42) or placebo (Albumin 582 mg/day, n=42) were administered for 7 days. Fetal weight gain, biophysical profile score and fetal heart rate monitoring were evaluated during the treatment week and until delivery. Comparisons were performed by intent-to-treat and relative risk (RR) and 95% Confidence Intervals (CI) were obtained. RESULTS: In each group, 27 women (64%) completed the allocated intervention. AT significantly decreased the worsening of the fetal biophysical profile score or fetal heart rate monitoring (RR 0.24, 95% CI 0.07-0.8), increased the incidence of estimated weight gain >15 g/day during the intervention week (3.1, 1.0-9.9), and prolonged gestational age to >or= 34 weeks (3.6, 1.05-12.6), however infant mortality rates did not differ between the two groups. No adverse events related to AT were observed. CONCLUSIONS: Supplementation of AT preserves fetal biophysical condition and weight gain in early onset severe pre-eclampsia and most likely prolongs pregnancies >or= 34 weeks of gestation.