Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

Phase 4

• Conditions: Hysteroscopy
• Interventions: Drug: placebo; Drug: vaginal dinoprostone

• Registration Number: NCT04042974
• Lead Sponsor: Cairo University

Brief Summary

To compare the effectiveness of vaginal dinoprostone with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Detailed Description

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes. The most commonly used agent is misoprostol, a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Last Update Submitted: 2019-07-31
• Study First Posted: 2019-08-02
• Last Update Posted: 2019-08-02
• Study Start: 2019-08-10
• Primary Completion: 2019-11-10
• Study Completion: 2019-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

Exclusion Criteria

• • women with suspected pregnancy

  • heavy vaginal bleeding
  • recent pelvic infection
  • those known to have hypersensitivity or contraindication to dinoprostone
  • those who received analgesics prior to OH
  • a concomitant neurologic disease that could affect the correct evaluation of pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
dinoprostone	vaginal dinoprostone	1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Intensity of pain	an expected average of 10 minutes	Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

Secondary Outcome Measures

Name	Time	Method
Operative time	an expected average 10 minutes	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Intensity of pain	30 minutes after the procedure	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10