Evaluation of the effect of Dilapane-S gel on preoperative cervical preparatio
Phase 3
Recruiting
- Conditions
- Hysteroscopy.
- Registration Number
- IRCT20191123045476N2
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
Postmenopausal women (at least 1 year after the last menstrual cycle) or Nolipar or Multipar who have no history of natural childbirth are candidates for hysteroscopic surgery due to uterine myoma and uterine polyp.
Postmenopausal women (at least more than 1 year after the last menstrual cycle) or Nolie Par or Multipar who have no history of normal delivery are candidates for hysteroscopic surgery due to increased endometrial thickness confirmed by ultrasound or abnormal vaginal bleeding
Exclusion Criteria
Contraindications to hysteroscopy
Recent or current pelvic infections
Previous cervical surgery
Confirmed cervical or breast malignancies
Vaginal delivery history
Hypersensitivity to misoprostol and prostaglandins
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cervical dilatation. Timepoint: The time required to start dilatation until the arrival of a hysteroscope or resectoscope will be recorded as a conclusion. Method of measurement: Initially, the initial condition of the cervix, including the position and softness of the cervix, will be evaluated observably. No resistance is passed as dilatation before hysteroscopy and will be recorded as a conclusion. Our ultimate goal will be dilatation with Hagar number 10-8.
- Secondary Outcome Measures
Name Time Method Severe pain and bleeding after hysteroscopy. Timepoint: Immediately after the patient regains consciousness. Method of measurement: visual analog scale, which includes a table to evaluate the patient's pain and bleeding in the form of zero indicates painless and ten indicates severe and unbearable pain and bleeding.