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

NCT07697781 | Recruiting DMC

• 1 other identifier: CERV-PREP-MENO-HSC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Postmenopausal women; Postmenopausal bleeding; Office hysteroscopy; Cervical preparation; Vaginal estrogen; Oral misoprostol; Visual Analog Scale; Vaginoscopy; No touch approach

Outcome Measures

Primary Outcomes (2)

• Successful office hysteroscopy

  A complete hysteroscopic examination of the uterine cavity.

  During the office hysteroscopy procedure

• Pain during office hysteroscopy

  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.

Secondary Outcomes (3)

• Procedure-related complications

  During the procedure and up to 24 hours after office hysteroscopy

• Patient satisfaction with cervical preparation

  Immediately after the procedure

• Adverse effects of cervical preparation

  From date of randomization up to 14 days

Study Arms (4)

No Cervical Preparation

OTHER

Participants undergo office hysteroscopy without any cervical preparation.

Other: No Cervical Preparation

Oral Misoprostol

EXPERIMENTAL

Participants receive 200 µg of misoprostol administered sublingually 2 hours before office hysteroscopy.

Drug: Misoprostol ( Cytotec) 200 microgram a tablet

7-Day Vaginal Estrogen

EXPERIMENTAL

Participants receive 20 µg vaginal estrogen once daily for 7 consecutive days before office hysteroscopy.

Drug: Vaginal Estrogen (7-Day Regimen)

14-Day Vaginal Estrogen

EXPERIMENTAL

Participants receive 20 µg vaginal estrogen once daily for 14 consecutive days before office hysteroscopy.

Drug: Vaginal Estrogen (14-Day Regimen)

Interventions

No Cervical Preparation OTHER

No pharmacological cervical preparation is administered before office hysteroscopy.

No Cervical Preparation

Misoprostol ( Cytotec) 200 microgram a tablet DRUG

Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.

Oral Misoprostol

Vaginal Estrogen (7-Day Regimen) DRUG

Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.

7-Day Vaginal Estrogen

Vaginal Estrogen (14-Day Regimen) DRUG

Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.

14-Day Vaginal Estrogen

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Medicine of Tunis: lead

Study Sites (1)

Maternity and neonatology center of Tunis

Tunis, Tunis Governorate, 1007, Tunisia

RECRUITING

Related Publications (7)

• Samy A, Nabil H, Abdelhakim AM, Mahy ME, Abdel-Latif AA, Metwally AA. Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study. Climacteric. 2020 Aug;23(4):397-403. doi: 10.1080/13697137.2020.1742685. Epub 2020 Apr 17.

  PMID: 32299254 BACKGROUND

• Sauvan M, Pourcelot AG, Fournet S, Fernandez H, Capmas P. Office hysteroscopy for postmenopausal women: Feasibility and correlation with transvaginal ultrasound. J Gynecol Obstet Hum Reprod. 2018 Dec;47(10):505-510. doi: 10.1016/j.jogoh.2018.08.018. Epub 2018 Sep 5.

  PMID: 30193870 BACKGROUND

• Wood MA, Kerrigan KL, Burns MK, Glenn TL, Ludwin A, Christianson MS, Bhagavath B, Lindheim SR. Overcoming the Challenging Cervix: Identification and Techniques to Access the Uterine Cavity. Obstet Gynecol Surv. 2018 Nov;73(11):641-649. doi: 10.1097/OGX.0000000000000614.

  PMID: 30468239 BACKGROUND

• Sorbi F, Fambrini M, Saso S, Lucenteforte E, Lisi F, Piciocchi L, Cioni R, Petraglia F. Office hysteroscopy in pre- and post-menopausal women: a predictive model. Gynecol Endocrinol. 2021 Mar;37(3):206-210. doi: 10.1080/09513590.2020.1864316. Epub 2020 Dec 26.

  PMID: 33356672 BACKGROUND

• Giorda G, Scarabelli C, Franceschi S, Campagnutta E. Feasibility and pain control in outpatient hysteroscopy in postmenopausal women: a randomized trial. Acta Obstet Gynecol Scand. 2000 Jul;79(7):593-7.

  PMID: 10929961 BACKGROUND

• Gorodeski GI. Effects of menopause and estrogen on cervical epithelial permeability. J Clin Endocrinol Metab. 2000 Jul;85(7):2584-95. doi: 10.1210/jcem.85.7.6671.

  PMID: 10902812 BACKGROUND

• Cooper NA, Smith P, Khan KS, Clark TJ. Does cervical preparation before outpatient hysteroscopy reduce women's pain experience? A systematic review. BJOG. 2011 Oct;118(11):1292-301. doi: 10.1111/j.1471-0528.2011.03046.x. Epub 2011 Jul 29.

  PMID: 21797959 BACKGROUND

MeSH Terms

Conditions

Metrorrhagia

Interventions

Misoprostol; Clinical Protocols

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• KHALED M NEJI

  Maternity and neonatology center of Tunis

  STUDY CHAIR

Central Study Contacts

Mohammed Amine Hannachi, Assistant professor

CONTACT

+21699696332; medaminehannachi3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 13, 2026
• Study Start: January 2, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

TU (1)