Benefits of Self-administered Vaginal Dinoprostone 12 Hours before Levonorgestrel-releasing Intrauterine Device Insertion in Nulliparous Adolescents and Young Women: A Randomized Controlled Trial.

Study Objective: To assess safety and efficacy of self-administered vaginal dinoprostone 12 hours before a 52-mg levonorgestrel intrauterine device (LNG-IUD) insertion in adolescents and young nulliparous women.

Design: Randomized controlled trial.

Setting: Tertiary referral hospital.

Participants: Nulliparous adolescents and young women aged 18-22 years.

Interventions: Participants were randomly assigned into 2 groups; the dinoprostone group (n = 65) received dinoprostone 3 mg vaginally, and the placebo group (n = 65) received placebo tablets vaginally.

Main Outcome Measures: Primary outcome was pain scores during LNG-IUD insertion measured using a visual analogue scale. Secondary outcomes were pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, Women's satisfaction score, need for additional analgesics, and side effects.

Results: The dinoprostone group had significantly lower pain scores during LNG-IUD insertion (2.83 ± 1.08 vs 3.95 ± 1.63), tenaculum placement (2.97 ± 1.41 vs 4.55 ± 1.53) and sounding of uterus (3.55 ± 1.71 vs 5.12 ± 1.37) compared with the placebo group (P < .001). No significant differences were found between both groups regarding anticipated pain scores (P = .85), pain during speculum insertion and 20 minutes postinsertion and insertion duration (P = .53). Women's satisfaction, provider reported ease of insertion, and need for additional analgesia were significantly better among dinoprostone users (P < .001, < .001, and .02, respectively). Side effects and procedure complications were similar for the 2 groups.

Conclusion: Self-administered dinoprostone 3 mg vaginally 12 hours before a 52-mg LNG-IUD insertion in nulliparous adolescent and young women effectively reduced pain during insertion and increased women's satisfaction and ease of insertion reported by clinicians.