Combined oral prednisolone and heparin versus heparin: the effect on peripheral
NK cells and clinical outcome in patients with unexplained recurrent miscarriage.
A double-blind placebo randomized controlled trial.
Author(s): Gomaa MF(1), Elkholy AG, El-Said MM, Abdel-Salam NE.
Affiliation(s): Author information:
(1)Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams
University, Egypt 28 Aly Ameen Street, Naser City, Cairo, Egypt,
mostafafouadg@gmail.com.
Publication date & source: 2014, Arch Gynecol Obstet. , 290(4):757-62
PURPOSE: To evaluate the efficacy of the use of oral Prednisolone and heparin
versus the use of heparin alone in treatment of patients with unexplained
recurrent miscarriage.
METHODOLOGY: The study was a double-blind placebo randomized control trial
conducted on 160 patients with unexplained recurrent miscarriage. Patients
recruited were randomized into two groups. The first group received oral
Prednisolone in addition to low dose aspirin and heparin, while the other group
received a placebo in addition to low dose aspirin and heparin. A peripheral
venous blood sample was taken from all included patients before starting
treatment and collected in heparinized tubes. Natural Killer (NK) cells were
checked in each sample and then re-checked in another sample at 20 weeks of
gestation.
RESULTS: We found that in the prednisolone group, 70.3 % of women had successful
outcome (defined as an ongoing pregnancy beyond 20 weeks gestation), while 29.7 %
miscarried before this gestation. On the contrary, among women in the placebo
group, 9.2 % had successful outcome while 90.8 % miscarried before 20 weeks,
which was statistically significant. On the other hand, we found that there were
no significant paired differences between initial serum levels of the NK cells
markers CD16 and CD56 and their levels at 20 weeks gestation in both groups.
CONCLUSION: The addition of prednisolone to heparin and low dose aspirin might be
beneficial in patients with unexplained recurrent miscarriage, and this effect
might be due to a suppressive effect of steroids on the peripheral CD16 NK cells
concentration.
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