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NCT07030218
A Warning Red Flag Classification System to Predict Risk of Vasovagal Event During Office Hysteroscopy
Conditions: Vasovagal Syncope (VVS), Presyncope
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 100
Sponsor: Tanvir Hospital
Location: Tanvir Hospital Hyderabad Telangana
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.
Eligibility Criteria
Inclusion Criteria:
* Women ≥18 years
* Prior gynecological care
* Informed consent provided
Exclusion Criteria:
* Inability to consent
* Psychiatric disorders or anxiolytic use
* Use of dilators or anesthesia above level 3a
* Family history of VVS
Source: ClinicalTrials.gov (NCT07030218). StuddyBuddy aggregates publicly available trial information.