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RECRUITING Not applicable ClinicalTrials.gov

Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies

Sponsor: Faculty of Medicine of Tunis • ClinicalTrials.gov ID: NCT07697781

Registry updated: 2026-10-16
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Description

The goal of this randomized controlled trial is to evaluate the effectiveness of different cervical preparation strategies before office hysteroscopy in postmenopausal women undergoing evaluation for intrauterine pathology. The main questions to answer are: Does cervical preparation improve the success rate of complete office hysteroscopy in postmenopausal women? Which cervical preparation strategy provides better patient tolerance, as assessed by pain intensity during the procedure? Researchers will compare four cervical preparation protocols (14-day vaginal estrogen, 7-day vaginal estrogen, oral misoprostol, and no cervical preparation) to determine their effects on procedural success, pain, procedure duration, and perioperative complications. Participants will be randomly assigned to one of the four cervical preparation protocols. They will undergo office hysteroscopy using a vaginoscopic ("no touch") approach without anesthesia. Then, they will have pain assessed using a visual analog scale (VAS) during the procedure. Finally, these informations will be collected: procedural success, procedure duration, bleeding, and perioperative complications.

Interventions

  • No Cervical Preparation (Other)
    No pharmacological cervical preparation is administered before office hysteroscopy.
  • Misoprostol ( Cytotec) 200 microgram a tablet (Drug)
    Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.
  • Vaginal Estrogen (7-Day Regimen) (Drug)
    Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.
  • Vaginal Estrogen (14-Day Regimen) (Drug)
    Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.

Eligibility criteria

Inclusion Criteria: * Women with postmenopausal status. * Scheduled for office hysteroscopy for the evaluation of suspected intrauterine pathology. * Able to understand the study procedures and provide written informed consent. Exclusion Criteria: * Known or suspected hormone-dependent malignancy (e.g., breast or endometrial cancer). * Active genital tract infection. * Contraindication or known hypersensitivity to misoprostol or vaginal estrogen. * Refusal to undergo office hysteroscopy without anesthesia. * Active uterine bleeding preventing adequate hysteroscopic visualization on the day of the procedure.

Conditions

Postmenopausal Women Intrauterine Diseases Endometrial Pathology Postmenopausal Bleeding Abnormal Uterine Bleeding (AUB)

Locations

  • Maternity and neonatology center of Tunis — Tunis, Tunis Governorate, Tunisia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record