gynecology and obstetrics medical project, gynecology journal, obstetrics, gynecologic oncology, reproductive medicine, gynecological endoscopy, ultrasonography, gynecology articles

Ginekologia i Poloznictwo
ISSN 1896-3315 e-ISSN 1898-0759

Efficacy and safety of different doses of vaginal misoprostol prior to intra uterine contraceptive device insertion: A randomized three arms double-blind clinical trial


Author(s): Mohamed H. Salama, Shaimaa G. Helmy, Mohamed E. Elhodiby, Mohammed A. El-Kadi and Maii Nawara*

Objective: To evaluate the efficacy and safety of different doses of vaginal misoprostol prior to intrauterine contraceptive device (IUD) insertion among women who had delivered by elective cesarean section (CS: no history of vaginal delivery).

Study Design: A randomized, double-blind, placebo-controlled trial.

Setting: Conducted in the Family Planning Clinic of Ain Shams University Maternity Hospital, Egypt, for a 3-month period.

Methods: Women (n=180) who wished insertion of copper IUD after elective CS were equally divided into three groups: Group 1 received 200 mcg misoprostol, Group 2 received 100 mcg misoprostol, and Group 3 received placebo. Misoprostol was administered vaginally, 3 hours before the IUD insertion. The primary outcome was pain scores (a 10 cm visual analogue scale (VAS)) within 5 minutes of IUD insertion. The secondary outcome was a 10-grade provider ease of insertion score.

Results: Group 1, compared with Group 2 and 3, showed significantly lower VAS score, VAS was significantly lower in Group 1 (1.7 ± 0.8) than Groups 2 and 3 (3.6 ± 0.9 and 3.7 ± 0.9, respectively), with no statistical significant difference between Groups 2 and 3. Mean ± SE (95% CI) for differences between Groups 1&3, Groups 2&3, and Groups 1&2 was - 2.0 ± 0.2 (-2.3–-1.7), 0.0 ± 0.2 (-0.4–0.3), and -2.0 ± 0.2 (-2.3–-1.6), respectively. Conclusion: 200 mcg vaginal misoprostol, compared with 100 mcg, offered better efficacy with no significant increase in the adverse effects.