Obstetric Cholestasis: Comparison of Maternal and Perinatal Outcome of Ursodeoxycholic Acid versus Placebo

Abstract

Objectives: Objective: To compare the maternal and perinatal outcomes of ursodeoxycholic acid with placebo in obstetric cholestasis. Method: It was an open randomized parallel-group study with convenient sampling, conducted at Pakistan ordinance factories hospital (POF Hospital) Wah Cantt, from 1st June 2016-30th May 2019. Patients with obstetric cholestasis of pregnancy, diagnosed between 24-34 weeks of gestation, were randomized to receive either ursodeoxycholic acid 500mg twice daily or placebo one capsule twice daily for 4 weeks. The data was collected on a pre-designed proforma. The data of 84 patients, who full fill the inclusion criteria were analyzed using SPSS vs 19. Maternal outcomes measured were a relief in pruritus and a decrease in hepatic alanine aminotransferase levels (ALT) at the end of 2 weeks and 4 weeks of treatment. The mode of delivery was noted. Fetal outcomes measured were meconium staining of amniotic fluid and the need for neonatal intensive care unit (NICU) admission. Results: The results showed significant improvement in maternal itch score (P=0.001) and serum transaminases level (p=0.001) in patients using UDCA as compared to placebo. Although there were less number of caesarean sections (p=0.36), meconium-stained liquor (p=0.29) and NICU admissions (P=0.33) in the UDCA group the differences were not statistically significant. Conclusion: Treatment with UDCA in obstetric cholestasis improved maternal complaint of itching and decreased raised transaminases levels but did not affect significantly the mode of delivery, incidence of meconium-stained liquor and NICU admissions. Keywords: Obstetric cholestasis, Ursodeoxycholic acid, perinatal outcome, Pruritus.