Background: Immune reconstitution inflammatory response syndrome (IRIS) is a recovery disease that may be triggered after starting ARV therapy in some individuals. The incidence of adverse pregnancy-fetal outcomes with IRIS has not been studied in Kenya among pregnant women, with focus only, on improved immune response and PMTCT after ART initiation. The indirect effect of ART, the maternal HIV - IRIS on pregnancy outcome has not been elucidated. More than 10% of the global burden of disease is due to pregnancy complications and adverse pregnancy and related birth outcomes and despite recent advances in obstetric medicine, pregnancy complications and adverse birth outcomes are a growing public health concern and economic burden on the health-care system. This has substantial burden of adverse pregnancy-fetal outcomes with prevalence of preterm birth, low birth weight, and small gestational age infants of 19.8%, 14.2%, and 12.6%, respectively, and of still birth and neonatal mortalityat1.9% and 0.4%, respectively. The aim of this study was to evaluate the effect of maternal HIV immune reconstitution inflammatory response syndrome on the risk of adverse pregnancy-fetal outcomes in HIV-1 positive; ART initiated pregnant women of reproductive age in selected hospitals, Nairobi, Kenya. Methodology: The study was conducted among 204 HIV-1 positive, ART initiated pregnant women of reproductive age in selected hospitals, Nairobi, Kenya. A prospective cohort study design was used where the subjects were recruited and followed from the end of first trimester for six and half months after they were confirmed to be HIV positive, and put on ARV treatment using a pretested data collection tool. Bivariate analyses with chi-square test to establish the association between the variables at p-value < 0.05. Logistic regression analysis was performed to identify independent outcome predictors. Adjusted relative risk at 95% confidence interval was determined. Results: The study indicated that, adverse pregnancy-fetal outcome cumulative incidence was 26.47% among women diagnosed with IRIS compared to 10.78% among women not diagnosed with IRIS. The incidence rate estimate was 0.012 and 0.0045 per person’s week respectively with a rate ratio of 012/.0045=2.7. Women with IRIS had 2.46 times the risk of experiencing an adverse pregnancy-fetal outcome compared to those who did not [OR=3; 95%CI: 1.4-6.4; P=.004]. LBW cumulative incidence was the highest with 11 (10.8%) among IRIS exposed women and 3 (2.9%) among non-IRIS exposed women and same case with PTB 8 (7.8%) and 3 (2.9%) respectively. Conclusion: There was a significant relationship of maternal HIV-immune reconstitution inflammatory response syndrome diagnosis with adverse pregnancy-fetal outcomes as a result of ART initiation among HIV-1 positive, pregnant women of reproductive age. This study observes that, being diagnosed with maternal HIV-IRIS following ART initiation during pregnancy among ART naive women is associated with experiencing an adverse pregnancy outcome. This should be a concern in clinical practice as IRIS has self-resolution, it may on the other hand affect pregnancy outcome negatively. PMTCT should integrate monitoring of suspected IRIS cases using the latest defined criteria for its diagnosis in pregnant women starting ant-retroviral therapy especially in resource limited areas.
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