Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial.

OBJECTIVE(S): To assess efficacy and safety of self-administered 3 mg dinoprostone vaginally in reducing pain during copper intrauterine device (IUD) insertion in parous women. DESIGN: Randomized, double-blinded, placebo-controlled trial. SETTING: Family planning clinic in a tertiary referral hospital. PATIENT(S): Multiparous women who were attending a family planning clinic and requesting copper IUD insertion. INTERVENTIONS(S): We randomly assigned 160 participants into two groups: The dinoprostone group (n = 80) received 3 mg dinoprostone vaginally, and the placebo group (n = 80) received placebo vaginally. MAIN OUTCOME MEASURE(S): Our primary outcome was mean pain scores during IUD insertion. Our secondary outcomes were mean pain scores during tenaculum application, during uterine sounding, and 15 minutes after insertion, ease of insertion, satisfaction score, need for additional analgesics, and side-effects. RESULT(S): Both groups showed no significant difference in anticipated pain score (P=.41), pain during tenaculum placement (P=.22), and pain during sound insertion (P=.07). The dinoprostone group had significantly lower pain scores during IUD insertion (34.8 ± 10.1 vs. 57.8 ± 11.8) and 15 minutes after insertion (20.6 ± 6.4 vs. 29.6 ± 6.2), easier IUD insertion (43.6 ± 21.9 vs. 64.7 ± 18.1), and higher satisfaction (83.9 ± 11.6 vs. 63.0 ± 9.1) compared with the placebo group. Fewer patients required additional analgesics in the dinoprostone group compared with the placebo group (P=.01). Side-effects were similar between the groups. CONCLUSION(S): Self-administered 3 mg dinoprostone vaginally before copper IUD insertion in parous women reduces pain scores during IUD insertion, making insertion easier and increasing women's satisfaction, with tolerable side-effects. CLINICAL TRIAL REGISTRATION NUMBER: NCT04046302.

Comparative study regarding effect of pH on Misoprostol in induction of labor in full term primigravida pregnant women, a double blind randomized controlled trial.

OBJECTIVES: To evaluate the effect of altering vaginal pH on induction of labor in full-term pregnancies using Misoprostol. METHODS: This randomized controlled trial was conducted at Kasralainy Hospital, Cairo University, Egypt and Algezeera Hospital, Egypt. A total of 218 healthy term primigravida pregnant women who were scheduled for pregnancy termination were recruited in the study. The included patients were divided into three groups; Group A: Those who received normal saline vaginal wash (0.9% NaCl), Group B: those who received alkaline vaginal wash (5% sodium bicarbonate) and Group C: those who received acidic vaginal wash (5% acetic acid). Patients received 25 µg of Misoprostol E1 (Vagiprost® Adwia Pharmaceuticals, Egypt) every 6 h for a maximum of 24 h (total of four potential doses). RESULTS: The 'acid' group participants took a mean time of 20.46 h to reach active stage of labor, followed by the 'normal saline' group with 21.45 h and the 'alkaline' group with 22.59 h. The difference between the groups was statistically significant, with a p-value of 0.013. CONCLUSIONS: Douching the vagina with acidic solution seems to supplement the effect of Misoprostol on inducing labor in full-term pregnancies, as evidenced by having the shortest mean time needed to reach active stage of labor.