| CTRI Number |
CTRI/2025/08/092732 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Screening |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Two Types of cervical Speculums to See the Cervix and Measure Patient Comfort in Women Visiting the Gynecology Clinic |
|
Scientific Title of Study
|
Percentage of cervix visualized and patient’s discomfort with Bouquet speculum in comparison with Cusco’s speculum during evaluation of uterine cervix in women attending Gynecology OPD - A
stratified randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rinisha V P |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
Room no 5
Gynecolgy Outpatient department
Women and children hospital
Jawaharlal Institute of Postgraduate Medical Education and Research
DHANVANTARI NAGAR
PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8921955343 |
| Fax |
|
| Email |
vpdrrinisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpitha A |
| Designation |
Associate professor |
| Affiliation |
JIPMER |
| Address |
cabin of Dr.Arpitha
2nd FLOOR
Women and children hospital JIPMER,
Dhanvatari nagar
pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9481068681 |
| Fax |
|
| Email |
drarpithagynonco@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpitha A |
| Designation |
Associate professor |
| Affiliation |
JIPMER |
| Address |
cabin of Dr.Arpitha
2nd FLOOR
Women and children hospital JIPMER,
Dhanvatari nagar
pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9481068681 |
| Fax |
|
| Email |
drarpithagynonco@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research Campus Rd
Gorimedu
Dhanvantari Nagar
Puducherry
India
605006 |
|
|
Primary Sponsor
|
| Name |
Dr Arpitha A |
| Address |
Cabin of Dr.Arpitha A
2nd floor
women and children hospital,
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
605006 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRinisha V P |
Jawaharlal Institute of Postgraduate Medical Education and Research Pondicherry |
Room number 5
Gynecolgy Outpatient department
Women and children hospital
Pondicherry
PONDICHERRY |
8921955343
vpdrrrinisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (2) ICD-10 Condition: N87||Dysplasia of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Examination with Bouquet speculum |
Examination of uterine cervix with Bouquet speculum to assess the percentage of cervix visualized and patinet discomfort in comparison to Cusco speculum during the period of 18 months |
| Comparator Agent |
Examination with Cuscos speculum |
Examination of the uterine cervix with Cuscos speculum to assess the percentage of cervix visualized and patients discomfort during the period of 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
all women of age more than or equal to 18 years, coming to Gynecology OPD in JIPMER |
|
| ExclusionCriteria |
| Details |
Virgin women
women with cervical, vaginal or vulval growth completely obliterating the visualization of cervix.
women with stenosed vagina post radiation therapy for any malignancy
Women with UV prolapse
women who underwent total hysterectomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of cervix visualized - subjectively and objectively.
discomfort experienced by the patient during examination using a 5point visual analog scale |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of use of speculums by the physician on a likert scale of 5.
Qualitative in depth interview with the clinician at the end of the study. |
2 YEARS |
|
|
Target Sample Size
|
Total Sample Size="620"
Sample Size from India="620"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a stratified randomized control trial comparing the Percentage of cervix visualized and patient’s discomfort with Bouquet speculum and Cusco’s speculum during evaluation of uterine cervix in women attending Gynecology OPD. the primary outcome measures will be To compare the percentage of cervix visualized with Bouquet speculum in comparison with Cusco’s speculum and To assess the discomfort level experienced by the patient with Bouquet speculum in comparison to Cusco’s speculum on a 5 point visual analogue scale. the secondary outcome will be the Quantitative assessment of the ease of use of Bouquet speculum in comparison to Cusco’s speculum on a 5point Likert scale and also qualitative assessment of the same atthe end of the study. my hypothesis is that Bouquet speculum is likely to be better in regard to both visualization of cervix and patient comfort. |