Determining the Optimal Time Interval between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized, Double-blind Trial

J Minim Invasive Gynecol. 2022 Jan;29(1):85-93. doi: 10.1016/j.jmig.2021.06.021. Epub 2021 Jul 1.

Abstract

Study objective: To determine the optimal timing of vaginal dinoprostone administration before office hysteroscopy (OH) in nulliparous women.

Design: Randomized, double-blind trial.

Setting: Tertiary referral hospital.

Patients: A total of 180 nulliparous women undergoing diagnostic OH.

Interventions: We randomly allocated the women to long-interval or short-interval dinoprostone groups: three mg dinoprostone was administered vaginally 12 hours before OH in the long-interval group and 3 hours before OH in the short-interval group.

Measurements and main results: The primary outcome was pain during OH measured using a 100-mm visual analog scale (0 = no pain; 100 = worst pain imaginable). The secondary outcomes were ease of hysteroscope passage, patient satisfaction score, and drug-related adverse effects. The patients in the long-interval dinoprostone group had lower pain scores during OH (p <.001). Contrarily, pain scores 30 minutes after the procedure were similar in both groups (p = .1). The patient satisfaction score was higher and clinicians found hysteroscope passage through the cervical canal easier and quicker in the long-interval dinoprostone group than in the short-interval group (p <.001, p = .003, and p <.001, respectively). Side effects were comparable in both study groups.

Conclusion: Vaginal dinoprostone administered 12 hours before OH was more effective than that administered 3 hours before OH in reducing pain during OH in nulliparous women, with easier hysteroscope insertion, shorter procedure duration, and higher patient satisfaction score.

Trial registration: ClinicalTrials.gov NCT04085757.

Keywords: Dinoprostone; Nulliparous women; Outpatient hysteroscopy; Pain.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravaginal
  • Dinoprostone
  • Double-Blind Method
  • Female
  • Humans
  • Hysteroscopy / adverse effects
  • Misoprostol*
  • Oxytocics*
  • Pain Measurement
  • Pregnancy

Substances

  • Oxytocics
  • Misoprostol
  • Dinoprostone

Associated data

  • ClinicalTrials.gov/NCT04085757