Amnifiltration in early amniocentesis for cytogenetic evaluation : randomized clinical trial

Abstract

Objective: To improve the culture quality of early amniocentesis by using the filter technique to reduce the duration of the culture time and improve the success rate of cell culture with minimize pregnancy and fetal outcome. Design: Randomized clinical trial with single blinding and stratified randomization. Intervention: Amnifiltration by using the sterivex filter with 0.45 micron pore size made of polivinyladine membrane. Result: 58 patients were included in the study, 6, 23 and 23 patients werel2 weeks, 13 weeks and 14 weeks respectively. The patients were randomized allocated into two groups, control group and treatment group, with 29 patients in each group. The culture time in the treatment group was 12.32 days and the culture time in the control group was 15.86 days, the difference was statistical significant (P=0.006). The culture failure was 13.79% in treatment group and 10.35% in the control group. The corrected culture failure in the treatment group was 3.8% after exclude the procedure related problem cases. No serious complication in both treatment and control group in 6-3 weeks follow up.