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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To measure visual analogue score for pain post procedure separately from the tolerance score. | The visual analogue score for pain is described as - zero which is equivalent to no pain and 10 is the worst possible pain | The visual analogue score of pain will be assessed postoperative/postprocedural, i.e immediately after the completion of the OH procedure. |
Inclusion Criteria:
Exclusion Criteria:
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women undergoing office hysteroscopy in the hospital / outpatient
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| Name | Affiliation | Role |
|---|---|---|
| Tanvir Dr. | Tanvir Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanvir Hospital | Hyderabad | Telangana | 500073 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26146089 | Background | 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. | |
| 40121697 | 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. |
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all individual participant data (IPD) that underlie results in a publication
June 2025 - July 2026
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
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2026 | Jun 25, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2025 | Jun 13, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure. |
| To measure the body mass index of participant undergoing office hysteroscopy | To measure the weight in kilograms, height in meters, which will be combined to report body mass index (BMI) in kg/m^2) | BMI is calculated when the participant is enrolled in the study to perform office hysteroscopy. |
| 34933096 | 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. |
| 12151827 | 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. |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |