Health Condition 1: N858- Other specified noninflammatory disorders of uterus
Conditions
Interventions
Intervention1: MISOPROSTOL: Misoprostol is a Prostaglandin analogue frequently used in Obstetrics and Gynaecology for cervical ripening. Available as 200 microgram tablet. Tab Misoprostol 200 microgra
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Any premenopausal nulliparous woman undergoing Office Hysteroscopy for any indication as deemed necessary upon clinical evaluation.
Exclusion criteria
Exclusion criteria: 1. Any contraindication for hysteroscopy i. An ongoing viable pregnancy ii. Genital tract malignancy iii. Active per vaginal bleeding iv. Active genital tract infection 2. Any contraindication for Misoprostol i. Hypersensitivity to Misoprostol ii. Uncontrolled severe asthma iii. Chronic liver or kidney disease iv. Porphyrias v. An ongoing viable pregnancy 3. Any contraindication for Clotrimazole i. Hypersensitivity to Clotrimazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ease of doing Office Hysteroscopy in premenopausal nulliparous women after vaginal application of 200 microgram of Misoprostol 4 hours prior to the procedure in comparison with placebo.Timepoint: 1)Time taken for cervical passage: starting when the scope touches the external os (Time point T1) and ending when leaving the cervix at the point of passing the internal os and entering uterine cavity (Time point T2). 2) Total operating time:- time taken in minutes starting when the hysteroscope touches the labia at the beginning of procedure (Time point T0) and ending when the scope leaves the vaginal canal after completion of procedure (Time point T3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain relief by vaginal application of 200 microgram Misoprostol in premenopausal nulliparous women 4 hours prior to Office Hysteroscopy in comparison with placeboTimepoint: Pain score as perceived by the patient during the procedure (Time point T0 to T3) and at 30 minutes after the procedure ( Time point T4) on a Visual Analogue Scale (VAS) ranging from 0 to 10 where â??0â?? represents â??no painâ?? and â??10â?? represents â??unbearable painâ??. | — |
Countries
India
Contacts
Public ContactDr Vinod G nair
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed