NCT07030218

A Warning Red Flag Classification System to Predict Risk of Vasovagal Syncope During Office Hysteroscopy

A New Red Flag Classification to Predict Vasovagal Syncope During Office Hysteroscopy: A Cross-Sectional Pilot Feasibility Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 46 (estimated)
• Sponsor: Tanvir Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this pilot cross sectional study is to identify participants at risk of vasovagal reaction/syncope(VVR/VVS) during office hysteroscopy. A predictive red flag classification system is being studied to improve procedural safety during office hysteroscopy. Researchers will perform office hysteroscopy as per the standard protocol by vaginoscopic technique. A nurse positioned at the head side of the participant will record signs and symptoms of VVR/VVS. The participant will be asked of the severity of the pain experienced during office hysteroscopy in relation to their menstrual cycle. The procedure will be discontinued at any point the participant wishes to stop.

Detailed description

Office hysteroscopy is increasingly utilized due to advancements in instrumentation and techniques; however, its adoption in routine gynecologic practice remains limited to 10-12% of cases. This under utilization is largely attributed to the perception of pain and lack of financial incentives. Consequently, fewer than 20% of gynecologists employ office hysteroscopy for the evaluation of intrauterine pathology. Although generally safe, vasovagal syncope (VVS) is the most concerning complication, with a reported prevalence ranging from 0.21% to 1.85%. Other complications include pain, infection, and bleeding. Surgeons often fail to anticipate vasovagal responses during the procedure. This study aims to develop a red flag classification system based on pain response to enable early recognition and prevention of VVS during office hysteroscopy. Research design This is a multicenter, cross-sectional, analytical pilot study enrolling women undergoing office hysteroscopy over 4 months. Sample Size Calculation Based on an estimated VVS rate of 6.3%, and using a 95% confidence interval, the sample size of 46 was calculated using Crutzen's online tool. Statistical Analysis Descriptive analysis will be conducted for continuous and categorical variables. Chi-square tests will evaluate the association between pain classification and vasovagal events. The STROBE checklist will guide reporting.

Conditions

• Vasovagal Syncope (VVS)

Interventions

Type	Name	Description
PROCEDURE	Office hysteroscopy	In office hysteroscopy will utilize 1.9-2.9 mm hysteroscopes (primarily Bettocchi) by the technique of vaginoscopy, without anesthesia or up to level 3a analgesia, in accordance with International Consensus Statement for Recommended Terminology Describing Hysteroscopic Procedures. The choice of distension medium and hysteroscope is left to the operator's discretion. A nurse positioned at the head of the patient will record signs and symptoms of VVR/VVS.

Timeline

• Start date: 2025-06-20
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2025-06-22
• Last updated: 2025-07-03

Locations

1 site across 1 country: India