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

NCT07030218 | Enrolling By Invitation

• 1 other identifier: TH/IEC/BHR/0154/2025/TNV/P1/V4
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasovagal Syncope (VVS)

Keywords

vasovagal syncope; hysteroscopy; red flag classification

Outcome Measures

Primary Outcomes (1)

• To evaluate the feasibility of a predictive red flag classification system for identifying patients at risk of vasovagal syncope during office hysteroscopy(OH), with the goal of enhancing procedural safety.

  During OH, a nurse positioned at the head of the patient will measure and record the tolerance level of the patient at the completion of the procedure using the Red flag Classification: Level Description Classification 0 Pain ≤ normal menstruation (Well tolerated) Green Flag 1. Pain \> menstruation, no signs of distress (Tolerated) Green Flag 2. Level 1 + objective signs (sweating, pallor, malaise) (Tolerated)Red Flag 3. Level 2 + facial pallor ± loss of consciousness (Not tolerated) Red Flag Normal menstruation is when the pain during periods does not interfere with daily activities. The level of pain tolerated by the women in relation to the menstruation. The feasibility will be assessed by 1) the checking the nurses records which capture the pain scores for any delays or missing data, 2 ) the number of post- procedural pain and tolerance score recorded by the nurse, 3) time taken to complete data 4)Completeness of the data. This information will be used to refine the protocol.

  The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure.

Secondary Outcomes (1)

• To assess the potential barriers in implementing the red flag classification system, as preparation for a future large-scale validation study

  The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure.

Other Outcomes (2)

• To measure visual analogue score for pain post procedure separately from the tolerance score.

  The visual analogue score of pain will be assessed postoperative/postprocedural, i.e immediately after the completion of the OH procedure.

• To measure the body mass index of participant undergoing office hysteroscopy

  BMI is calculated when the participant is enrolled in the study to perform office hysteroscopy.

Interventions

Office hysteroscopy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women undergoing office hysteroscopy in the hospital / outpatient

You may qualify if:

• Women ≥18 years
• Prior gynecological care
• Informed consent provided

You may not qualify if:

• Inability to consent
• Psychiatric disorders or anxiolytic use
• Use of dilators or anesthesia above level 3a
• Family history of VVS

Sponsors & Collaborators

• Tanvir Hospital: lead

Study Sites (1)

Tanvir Hospital

Hyderabad, Telangana, 500073, India

Location

Related Publications (4)

• Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.

  PMID: 26146089 BACKGROUND

• Ubeda A, Cabrera S, Escales C, Funes B, Martinez M, Puche A, Martinez Garcia S. Predictors of vasovagal symptoms or syncope during outpatient diagnostic hysteroscopy: A prospective observational study. Eur J Obstet Gynecol Reprod Biol. 2025 May;309:121-125. doi: 10.1016/j.ejogrb.2025.03.044. Epub 2025 Mar 20.

  PMID: 40121697 BACKGROUND

• Munro MG, Kasiewicz JL, Desai VB. Office versus Institutional Operative Hysteroscopy: An Economic Model. J Minim Invasive Gynecol. 2022 Apr;29(4):535-548. doi: 10.1016/j.jmig.2021.12.008. Epub 2021 Dec 18.

  PMID: 34933096 BACKGROUND

• Isaacson K. Office hysteroscopy: a valuable but under-utilized technique. Curr Opin Obstet Gynecol. 2002 Aug;14(4):381-5. doi: 10.1097/00001703-200208000-00004.

  PMID: 12151827 BACKGROUND

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanvir Dr.

  Tanvir Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 22, 2025
• Study Start: June 20, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2025 -December 2025
• Access Criteria: The individual participant data ( IPD ) will be accessible to qualified researchers doing independent scientific research after reviewing the research protocol and statistical analysis plan and execution of data sharing agreement

Locations

IN (1)