title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Egypt 28 Aly Ameen Street, Naser City, Cairo, Egypt, mostafafouadg@gmail.com.
authors.forename: Mostafa F
authors.initials: MF
authors.lastname: Gomaa
authors.forename: Abdellatif G
authors.initials: AG
authors.lastname: Elkholy
authors.forename: Mourrad M
authors.initials: MM
authors.lastname: El-Said
authors.forename: Nermine E
authors.initials: NE
authors.lastname: Abdel-Salam
mesh_terms: D000026:Abortion, Habitual / Q000517:prevention & control*; D000284:Administration, Oral; D000328:Adult; D001241:Aspirin / Q000627:therapeutic use; D019002:CD56 Antigen / Q000097:blood; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D058851:GPI-Linked Proteins / Q000097:blood; D005938:Glucocorticoids / Q000627:therapeutic use*; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D007694:Killer Cells, Natural / Q000187:drug effects*; D011239:Prednisolone / Q000627:therapeutic use*; D011247:Pregnancy; D017452:Receptors, IgG / Q000097:blood; D055815:Young Adult
chemical_list: D019002:CD56 Antigen; C428200:FCGR3B protein, human; D005343:Fibrinolytic Agents; D058851:GPI-Linked Proteins; D005938:Glucocorticoids; C522918:NCAM1 protein, human; D017452:Receptors, IgG; D006493:Heparin; D011239:Prednisolone; D001241:Aspirin