Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion: A Randomized Double-Blind Clinical Trial

Abstract

Objective This study aims to compare the efficacy and safety of different doses of vaginal misoprostol prior to IUCD insertion among women with nulliparous cervix “those who 29never delivered-vaginally”. Study design: The current study was a randomized, double-blind, placebo-controlled trial conducted in the Family Planning Clinic of Ain Shams University’s Maternity Hospital Egypt. It involved women who delivered only by elective CD (cesarean delivery). One hundred and eighty women were randomized into three groups, Group 1 received misoprostol 200 mcg. Group 2 received misoprostol 100 mcg. Group 3 received placebo. The primary outcome was pain scores which were measured using a visual analogue scale (VAS), the secondary outcome was the ease of insertion score (ES). Results VAS and ES were significantly lower in group 1 compared to group 2 and group 3 (P < 0.001).There was insignificant difference among the three groups as regards successful IUD insertion (P = 0.477). Duration of insertion was significantly lower in group 1 than group 2 (P < 0.001). Satisfaction was significantly higher in group 1 compared to group 2 and group 3 (P < 0.001) Conclusion The effect of misoprostol seems to be dose-dependent. Dose of 200mcg seems to be ideal with best efficacy and with no significant increase in the adverse effects Implications: The dose of 200mcg vaginal misoprostol prior to IUD insertion in women, who had never delivered vaginally before, seems to be the most effective dose. Trail to lower the dose to100mcg significantly compromises the efficacy without remarkable benefit on the side effect profile.

Different Routes for Misoprostol Usage Before Intra Uterine Contraceptive Device Insertion in Women with Previous Cesarean Section

“…Before inserting an IUD, Helmy et al [19] assessed the effectiveness of various vaginal misoprostol dosages in women with nulliparous cervixes. They discovered that a 200-g dosage of misoprostol made IUD insertion simpler and significantly reduced VAS pain levels.…”

Comparative efficacy of lidocaine–prilocaine cream and vaginal misoprostol in reducing pain during levonorgestrel intrauterine device insertion in women delivered only by cesarean delivery: A randomized controlled trial

“…51 We used a small dose of misoprostol (200 μg) for better tolerability and safety as the side effects are dose-dependent. 45,50 Lower doses of misoprostol (e.g.,100 μg) significantly compromise the efficacy without remarkable benefit on the side effect profile. 45 Several studies have addressed cervical local anesthetics to reduce pain during IUD insertion.…”

“…We also preferred the vaginal route for misoprostol administration as it is associated with faster cervical priming and dilatation with fewer side effects 51 . We used a small dose of misoprostol (200 μg) for better tolerability and safety as the side effects are dose‐dependent 45,50 . Lower doses of misoprostol (e.g.,100 μg) significantly compromise the efficacy without remarkable benefit on the side effect profile 45 …”

“…45,50 Lower doses of misoprostol (e.g.,100 μg) significantly compromise the efficacy without remarkable benefit on the side effect profile. 45 Several studies have addressed cervical local anesthetics to reduce pain during IUD insertion. They were used in different formulations (e.g., gel, injections, and spray) and with different techniques for administration (intracervical and paracervical).…”

“…Numerous studies agreed with our findings and reported reduced pain scores and easier insertions with misoprostol or dinoprostone utilization compared to placebo, [10][11][12][13]38,39 while other studies recommended against their routine utilization due to lack of efficacy and frequent side effects. 14,[40][41][42][43][44] Helmy et al 45 evaluated the efficacy of different doses of vaginal misoprostol prior to IUD insertion among women with a nulliparous cervix. They found a significant reduction of VAS pain scores with easier IUD insertion with a 200μg dose of misoprostol.…”