RESUMO
BACKGROUND AND OBJECTIVE: There has been concerns regarding the safety of Warfarin in pregnant females due to its teratogenic potential. At the same time warfarin provides best anticoagulation in patients with prosthetic valves. Various dosage regimes have been tried to strike a balance between safety of mother and the avoidance of congenital anomalies in the newborn. This study was conducted to observe the effect of Warfarin in pregnant mothers taking different doses of warfarin, and their neonatal outcome, in our outdoor patients. METHODS: This is a cross sectional observational study conducted at the Faisalabad Institute of Cardiology. The pregnant mothers taking warfarin for prosthetic valve replacement who presented to our specialized clinic between November 2016 to April 2017 were included in the study. These included a total of 75 females between the age of 20-35 years. To compare the dose related effect of warfarin, two groups of the patients were formed. One group comprised of patients taking warfarin ≤5mg while the other group consisted of those who were taking >5mg of warfarin daily. These patients were followed till their delivery. The information was collected about the maternal and fetal outcomes. The maternal outcomes including mode of delivery/miscarriage, peripartum bleeding and any valve related thromboembolic complications. The fetal outcomes included birth weight, maturity, embryopathy and congenital anomaly in the baby. RESULTS: Patient's mean age was 29.25±3.75 years. The mitral valve replacement was present in 60% patients (n=45) while 25.3% patients (n=19) had aortic valve replacement and 14.7% patients (n=11) had double valve replacement. In this group 30 patients (40%) had taken <5 mg warfarin and 45 patients (60%) had received >5 mg warfarin medicine. Miscarriages, cesarean sections, low birth weight and prematurity were more common in patients receiving warfarin >5 mg with p-values 0.005, 0.046, 0.01 and 0.033 respectively. No case of fetal embryopathy was found in both groups. CONCLUSION: No case of embryopathy was found in each group which signifies that warfarin in lower doses is safe anticoagulant in patients with prosthetic valve replacements.
RESUMO
OBJECTIVES: To evaluate the effect of oral progesterone for the treatment of abnormal uterine bleeding in patients taking warfarin after prosthetic valve replacement. METHODS: A total of 85 women of reproductive age, who were on warfarin due to prosthetic valve replacement were enrolled in the study. After detailed evaluation, their menstrual bleeding was quantified using Pictorial Bleeding Evaluation Chart. The patients were then prescribed an oral progesterone (Norethisterone) 5mg three times daily. The first follow up was done after one-month then at 3-months and at six months. The improvement in PBAC score was recorded at each visit. Data was entered and analyzed using SPSS (version 23.0). The mean ± Standard Deviation were calculated for quantitative variables while qualitative variables were presented in frequency table. The normality of data was checked using Kolmogorov-Smirnov test. Due lack of normal distribution of data in various groups, the Wilcoxon Sign Rank test was used to test the significance before and after treatment. The p-value of <0.05 was taken as statistically significant. RESULTS: The mean age of the patients was 30.13±7.69 years. The mean PBAC score was 162.8 ± 24.86 before initiation of treatment while at the end of the treatment it was 105.48 ± 8.38. Forty-six (54.1%) patients had continuous per vaginal bleeding, 33 (38.8%) had menorrhagia, 4 (4.7%) had inter-menstrual bleeding and 2 (2.4%) had menorrhagia along with polymenorrhea. The mean dose of warfarin taken by the patients was 5.85 ± 2.69 mg. The median parity of the patients was 2. The Wilcoxon Sign Rank test showed p-value of <0.00001 for comparison of the pre-treatment PCBA values with those of one, three and six-months after the treatment. The Friedman's test also had a p-value of <0.00001. This confirmed that the post treatment bleeding was significantly less than pretreatment bleeding. CONCLUSION: The warfarin induced abnormal uterine bleeding can be controlled effectively and safely with low dose of oral progesterone.