Health Condition 1: N950- Postmenopausal bleeding
Conditions
Interventions
Intervention1: Tab. Isonicotinic acid hydrazide for cervical dilatation: Use of Tab. Isonicotinic acid hydrazide for cervical dilatation 4 hours prior to surgery
Control Intervention1: Misoprostol tab
Sponsors
Dr Suman Sandeep Samal
Eligibility
Inclusion criteria
Inclusion criteria: Age more than or equal to 18 years b) Written informed consent c) No contraindications for isoniazid or misoprostol d) Absence of active pelvic infection or uterine malignancy e) No history of prior cervical surgeries f) Not pregnant or breastfeeding
Exclusion criteria
Exclusion criteria: Known allergy to either isoniazid or misoprostol b) Severe liver diseases or renal insufficiency c) Active pelvic infections d) Gynecological malignancies e) Immunocompromised patients or those on medications affecting isoniazid or misoprostol metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Cervical Dilatation: The degree of cervical dilatation will be measured with a Hegar dilator just prior to the procedure, with results recorded in millimeters (the size of the dilator that enters easily through the cervix). Timepoint: At the time of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure Time: Total duration from start of the procedure to entry into the uterine cavity Adverse Events: Side effects such as nausea, vomiting, headache, fever or vaginal bleeding in the post-operative period Complications: Any significant complications such as uterine perforation or cervical laceration Surgeon Satisfaction: A post-procedure questionnaire will assess surgeon satisfaction with cervical dilation and overall comfort during the procedure using a visual analog scale (VAS), where 0 represents inability to enter through the cervix and 5 represents very easy cervical entry (0: unable to enter the cervix, 1: very difficult entry, 2: moderately difficult, 3: mild difficulty elicited, 4: easy cervical entry, 5: very easy). Timepoint: After obtaining approval for 18 months | — |
Countries
India
Contacts
Public ContactDr Suman Sandeep Samal
All India Institute of Medical Sciences, Kalyani
Outcome results
None listed