Clinical Outcome of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Before T380A Copper Intrauterine Device Insertion in Adolescent and Young Women: A Double-Blind Randomized Controlled Study

Abstract

Background & Objective: To see if 900 mg of vaginal isonicotinic acid hydrazide (INH) given 12 hours before insertion of a T380A copper intrauterine device (IUD) was more effective than placebo in increasing insertion ease and reducing insertion discomfort in nulliparous ladies. Materials & Methods: A double-blind, randomized controlled study recruited nulliparous women who wanted to use the Copper IUD for contraception. Women who were WHO-eligible for IUD implantation were recruited and randomly assigned (1:1) to vaginal INH 900 mg or placebo (n=100 in each group), 12 hours before the IUD was placed. The primary endpoint was the ease of insertion for the providers. The number of unsuccessful IUD insertions was also recorded. Results: The groups had similar baseline characteristics. The ease of insertion score in the INH group was lower than in the placebo group (3 (2-5).5 vs. 6 (3-8); P= 0.01), indicating that physicians in the INH group had an easier time inserting the device. The INH group had a reduced mean pain score during the procedure (3.97 ± 0.991 vs. 6.42 ± 0.66; P= 0.001). In the INH group, two incidences of failed IUD insertion occurred (2%) compared to four cases in the control group (4 percent). 0.594 is the p-value. Conclusion: Self-administered INH 900 mg vaginally 12 hours before a copper T380A IUD insertion successfully reduced discomfort during insertion and improved women's satisfaction and ease of insertion as measured by physicians in nulliparous teenagers and young ladies.