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

RecruitingNAAges any - anyFemaleFaculty of Medicine of Tunis
NCT07697781 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 vagi

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📋 Eligibility rules (as published)
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.
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What it tests

  • No Cervical Preparation
  • Misoprostol ( Cytotec) 200 microgram a tablet
  • Vaginal Estrogen (7-Day Regimen)
  • Vaginal Estrogen (14-Day Regimen)
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Where

1 site
Maternity and neonatology center of Tunis
Tunis, Tunisia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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