Feasibility and pain control in outpatient hysteroscopy in postmenopausal women: a randomized trial.
G Giorda, C Scarabelli, S Franceschi...
https://pubmed.ncbi.nlm.nih.gov/10929961/Actively Recruiting
Led by Faculty of Medicine of Tunis · Updated on 2026-07-13
120
Participants Needed
1
Research Sites
3 weeks
Total Duration
Researchers are evaluating different cervical preparation methods before office hysteroscopy in postmenopausal women who are being checked for intrauterine conditions. The study aims to find out if cervical preparation improves the success of the hysteroscopy and which method offers better pain tolerance during the procedure. Four preparation strategies are compared, including vaginal estrogen for 7 or 14 days, oral misoprostol, and no preparation. Participants are randomly assigned to one of four groups no cervical preparation, sublingual misoprostol 200 micrograms given 2 hours before the procedure, vaginal estrogen 20 micrograms once daily for 7 days, or vaginal estrogen 20 micrograms once daily for 14 days before the hysteroscopy. The hysteroscopy uses a no touch vaginoscopic approach without anesthesia. During the study, participants will have pain measured using a visual analog scale during and after the procedure. Researchers will record the success of the hysteroscopy, procedure duration, bleeding, and any complications occurring during or within 24 hours after the procedure. Patient satisfaction and side effects from the cervical preparation will also be evaluated up to 14 days after randomization.
CONDITIONS
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
M
Mohammed Amine Hannachi, Assistant professor
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Faculty of Medicine of Tunis
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days before the procedure
Participants receive one of four cervical preparation methods before office hysteroscopy or no preparation. The hysteroscopy is performed without anesthesia using a no-touch vaginoscopic approach.
1 treatment period and 1 office hysteroscopy visit
Duration - Up to 14 days after treatment
Researchers evaluate pain, procedure success, complications, and patient satisfaction during and shortly after the hysteroscopy. Adverse effects from cervical preparation are monitored for up to 14 days.
Follow-up visits or contacts as needed
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Lead Sponsor