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Vasovagal Syncope (VVS)FLAG-VSNCT07030218

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

An observational study of Vasovagal Syncope (VVS) and Presyncope, run by Tanvir Hospital at 1 site in India.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Vasovagal Syncope (VVS), Presyncope
What is being tested?
Office hysteroscopy
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteIndia
Study dates
20 Jun 2025to 12 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: women undergoing office hysteroscopy in the hospital / outpatient

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Tanvir Hospital

    Hyderabad, Telangana, 500073

Other trials in India

About this study

Official title: A New Red Flag Classification to Predict Vasovagal Event During Office Hysteroscopy: A Prospective Feasibility Study

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.

Read the 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 single center, prospective observational pilot study enrolling women undergoing office hysteroscopy over 10 months.

Sample Size Calculation As this is a pilot feasibility study, a formal power calculation for hypothesis testing was not applicable. Sample size was determined using a precision-based approach. Based on a published vasovagal event rate of 6.5 % during office hysteroscopy, we estimated that 100 participants would be required to estimate this proportion with a 95% confidence interval and a margin of error of ±5%, using the Wilson score method. No formal stopping rules or interim analyses were pre-specified, consistent with the pilot and exploratory nature of this study.

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.

Being tested
Office hysteroscopy
Keywords
vasovagal syncope, hysteroscopy, red flag classification, presyncope
Medical subject headings
Syncope, Vasovagal, Syncope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Office hysteroscopyProcedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

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

    The potential barriers are assessed by 1) reviewing the recruitment rate versus the target sample size, 2 ) drop out rate, 3 ) nurses feedback on the ease of recording the tolerance classification, 4) Patient's understanding of the classification and their acceptability to report pain.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start20 Jun 2025
  3. Primary completion10 Jul 2026 (estimated)
  4. Study completion12 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030218
Sponsor's protocol ID
TH/IEC/BHR/0154/2025/TNV/P1/V4
Acronym
FLAG-VS
Status last verified
Jul 2025
First submitted
20 May 2025
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all individual participant data (IPD) that underlie results in a publication

Publications

  • 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.

    PubMed 26146089

  • 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.

    PubMed 40121697

  • 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.

    PubMed 34933096

  • 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.

    PubMed 12151827

Questions about this trial

What is this clinical trial studying?

An observational study of Vasovagal Syncope (VVS) and Presyncope, run by Tanvir Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07030218, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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