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Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently, the available instruments are traumatic tenacula, which could cause pain and bleeding and therefore represent an obstacle for certain patients to pursue their medical follow-up.
AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting its specific semi-circular anatomic shape through a system powered by a vacuum chamber.
The aim of our comparative study is to assess the patient's pain and bleeding using the AspivixTM device in comparison with a commonly used single-tooth tenaculum (Pozzi forceps). Additionally, the comparative study aims to assess and compare the safety of the AspivixTM device with the single-tooth tenaculum (Pozzi forceps).
Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding pilot study is registered separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-tooth tenaculum (Pozzi forceps) | Active Comparator | In the control arm, a single-tooth tenaculum, Pozzi forceps, used during routine IUD insertion, is employed to hold and stabilize the cervix. |
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| AspivixTM cervical vacuum tenaculum | Experimental | In the experimental arm, the investigational AspivixTM cervical vacuum tenaculum is employed to hold and stabilize the cervix. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traction of the cervix for IUD insertion | Procedure | Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | Before the procedure |
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During speculum insertion |
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During AspivixTM / standard tenaculum application |
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During application of cervical traction |
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During IUD insertion |
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of placement attempts before traction can be applied | number of placement attempts before traction can be applied The number of placement attempts before traction of the cervix can be applied will be recorded | During the procedure to insert the IUD which should last less than 5 minutes. |
| The number of spontaneous releases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Mathevet, Prof. | DFME CHUV Lausanne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUG - Department Women, Child & Adolescent | Geneva | Canton of Vaud | 1205 | Switzerland | ||
| Department Women, Mother & Child, University Hospital |
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Single-blinded - Participants will be blinded towards the intervention used. Additionally, the type of device used will only be revealed to the practitioner after randomization, immediately prior IUD insertion.
| During AspivixTM / standard tenaculum release |
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | 5 minutes after the end of the procedure |
The number of spontaneous releases during traction of the cervix will be recorded |
| During the procedure to insert the IUD which should last less than 5 minutes. |
| Assessment of the efficacy of the investigational device and its comparator by the practitioner | 5 point Likert 'Efficacy Questionnaire' will be used. Minimal to maximal values range from 1 to 5, 1 meaning "disagree" and 5 "agree". | During the procedure to insert the IUD which should last less than 5 minutes. |
| Assessment of bleeding | To assess bleeding, every buffer will be weighted, and the blank weight subtracted. Weight in mg will be reported in the case report form. | During the procedure to insert the IUD which should last less than 5 minutes. |
| Assessment of adverse events | Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants) | During the procedure to insert the IUD which should last less than 5 minutes. |
| Assessment of device deficiencies | Safety of the procedure will be assessed by documenting device deficiencies (description) | During the procedure to insert the IUD which should last less than 5 minutes. |
| Identification of new risks | Safety of the procedure will be assessed by identifying and documenting any new risk. | During the procedure to insert the IUD which should last less than 5 minutes. |
| Lausanne |
| Canton of Vaud |
| 1011 |
| Switzerland |