Abstract
OBJECTIVE: To assess cytokines(TNFα, IL6) and pentraxin3(PTX3) in unexplained recurrent pregnancy loss(RPL) compared to controls and to evaluate immunomodulatory effect of oral micronized progesterone. METHODS: This prospective comparative trial was conducted in 90 pregnant females: 60 RPL(group-1) and 30 controls(group-2). Group-1 was randomized into group-1a (n = 30) receiving oral micronized progesterone 200 mg twice daily and group-1b (n = 30) not receiving progesterone. TNFα(Th1-cytokine), IL6(Th2-cytokine) and PTX3 were measured at baseline(< 8 weeks), 16 weeks and at abortion/delivery. RESULTS: In all three groups, baseline TNFα, IL6 and PTX3 were similar; and levels increased as pregnancy advanced. However, progesterone modulated the rise favorably in group-1a, which was similar to controls (group-2). A significant rise at 16 weeks was noted for TNFα in group-1b (p = 0.0002); IL6 in group-1a (p = 0.0001) and group-2 (p = 0.04); and PTx3 in group-1b (p = 0.028); number of previous abortions not affecting rise. The abortion rate was 3.5% vs. 16.7% in group-1a and 1b, respectively. No patient aborted if baseline TNFα was < 6.5 pg/ml and PTx3 was < 3441 pg/ml. CONCLUSION: Favorable shift in TNFα, IL6 and PTx3 levels with oral micronized progesterone appears to exert immunomodulatory effect that support pregnancy continuation in RPL. Baseline TNFα < 6.5 pg/ml and PTx3 < 3441 pg/ml have good pregnancy outcome even without progesterone support. Women with higher levels than these can be offered progesterone therapy. Trial registration Clinical trial registry of India (CTRI/2016/09/007278).