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

7. september 2026 opdateret af: Mohammed Amine HANNACHI, Faculty of Medicine of Tunis

A Four-Arm Prospective Randomized Controlled Trial Comparing Oral Misoprostol, Two Vaginal Estrogen Regimens, and No Cervical Preparation Before Office Hysteroscopy in Postmenopausal Women

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tunesien
    • Tunis Governorate
      • Tunis, Tunis Governorate, Tunesien, 1007

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: No Cervical Preparation
Participants undergo office hysteroscopy without any cervical preparation.
Andet: No Cervical Preparation
No pharmacological cervical preparation is administered before office hysteroscopy.
Eksperimentel: Oral Misoprostol
Participants receive 200 µg of misoprostol administered sublingually 2 hours before office hysteroscopy.
Medicin: Misoprostol ( Cytotec) 200 microgram a tablet
Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.
Eksperimentel: 7-Day Vaginal Estrogen
Participants receive 20 µg vaginal estrogen once daily for 7 consecutive days before office hysteroscopy.
Medicin: Vaginal Estrogen (7-Day Regimen)
Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.
Eksperimentel: 14-Day Vaginal Estrogen
Participants receive 20 µg vaginal estrogen once daily for 14 consecutive days before office hysteroscopy.
Medicin: Vaginal Estrogen (14-Day Regimen)
Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Successful office hysteroscopy
Tidsramme: During the office hysteroscopy procedure
A complete hysteroscopic examination of the uterine cavity.
During the office hysteroscopy procedure
Pain during office hysteroscopy
Tidsramme: During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.
Patient-reported pain assessed using a 10-cm Visual Analog Scale (VAS) during hysteroscopy, 5 minutes after the procedure and 10 minutes after the procedure. 0 is assigned to no pain & 10 is assigned to the most pain imaginable.
During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedure-related complications
Tidsramme: During the procedure and up to 24 hours after office hysteroscopy
Incidence of complications occurring during or immediately after office hysteroscopy, including cervical laceration, uterine perforation, excessive bleeding, vasovagal reaction, or failure requiring conversion to hysteroscopy under anesthesia.
During the procedure and up to 24 hours after office hysteroscopy
Patient satisfaction with cervical preparation
Tidsramme: Immediately after the procedure
Patient satisfaction with the assigned cervical preparation protocol, assessed using a Patient Satisfaction Percentage Scale, a self-reported scale ranging from 0% to 100%, where 0% indicates not satisfied at all and 100% indicates completely satisfied. Higher scores indicate greater patient satisfaction.
Immediately after the procedure
Adverse effects of cervical preparation
Tidsramme: From date of randomization up to 14 days
Incidence of adverse effects related to cervical preparation, including abdominal pain, uterine cramping, vaginal bleeding, nausea, vomiting, diarrhea, headache, dizziness, or local vaginal irritation.
From date of randomization up to 14 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Faculty of Medicine of Tunis

Efterforskere

  • Studiestol: KHALED M NEJI, Maternity and neonatology center of Tunis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. januar 2026

Primær færdiggørelse (Faktiske)

30. juli 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CERV-PREP-MENO-HSC

Plan for individuelle deltagerdata (IPD)

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