Two Different Doses of Self-Administered Vaginal Misoprostol for Successful Copper Intrauterine Device Insertion in Parous Women Previously Delivered By Cesarean Section. A Double Blinded Randomized Clinical Trial

Abstract

Background: The main reasons associated with a low IUCD use are high cost in some settings and fear of pain at insertion by women. This double blind randomized controlled clinical trial study will evaluated and compare the efficacy and safety of misoprostol 200 mcg versus 400 mcg administered vaginally prior to IUCD insertion regarding the success and ease of insertion procedure among parous women beside the rate of occurrence of adverse effects. Objective: To evaluate and compare the efficacy and safety of misoprostol 200 mcg plus placebo versus 400 mcg administered vaginally prior to IUCD insertion in regard to the success and ease of insertion procedure among parous women previously delivered by cesarean section beside the rate of occurrence of adverse effects. Patients and Methods: This double blind randomized controlled clinical trial was conducted at Ain Shams University Maternity Hospital (Family planning clinic) during the period from January 2020 till July 2020, to evaluate and compare the efficacy and safety of misoprostol 200 mcg plus placebo versus 400 mcg administered vaginally prior to IUCD insertion in regard to the success and ease of insertion procedure among parous women beside the rate of occurrence of adverse. One hundred parous women previously delivered by cesarean section were randomized into 2 equal groups; group (1): 50 women received misoprostol 400 mcg (2 tablets) vaginally 3 hours prior to IUCD insertion and group (2): 50 women received misoprostol 200 mcg plus placebo vaginally 3 hours prior to IUCD insertion (the placebo tablet has the same color, size and shape of tab of misoprostol). Results: Regarding baseline patient’s characteristics (Age, BMI, parity, previous miscarriages, previous CS, previous use of contraceptives and previous insertion of IUD); statistical analysis of current results showed that there were insignificantly different between both groups. Statistical analysis of current results showed that VAS ranged between 1 and 5 with a mean value of 2.16 ± 0.93 in group 1 and between 1 and 5 with a mean value of 2.55 ± 1.21 in group 2. It was insignificantly different between both groups. However, needing for analgesia was significantly lower in group 1 than group 2 (P = 0.004). Successful IUD insertion was insignificantly different between both groups. Woman's level of satisfaction was insignificantly different between both groups. All side effects were insignificantly different between both groups except abdominal cramping and shivering were significantly lower in group 2 than group 1. Conclusion: In cases of intrauterine contraceptive devices (IUCDs) insertion, there was between different doses of misoprostol (400 vs. 200) regarding degree of pain, success of insertion, women’s satisfaction or pharmacological side effects However needing for analgesia was significantly lower and adverse effects as abdominal cramping and shivering were significantly higher in women received higher doses of misoprostol.