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This study aims to determine whether an Allis clamp is an effective clamp for cervical stabilization compared to a single-tooth tenaculum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IUD placement with allis clamp | Experimental |
| |
| IUD placement with single tooth tenaculum | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allis clamp | Procedure | Physicians utilized an Allis clam for cervical stabilization during IUD placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experienced bleeding after IUD placement | Number of patients who experienced bleeding after IUD placement with an Allis clamp or single-tooth tenaculum. | At the time of IUD insertion |
| Measure | Description | Time Frame |
|---|---|---|
| IUD insertion success rate | The percentage of participants who successfully had an IUD placed with an Allis clamp or single-tooth tenaculum. | At the time of IUD insertion |
| Number of interventions required for cervical clamp site bleeding hemostasis |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Rone, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36477274 | Derived | Andrews B, Quick K, MacLeod E, Edwards K, Rone BK. Cervical bleeding with cervical stabilization during IUD placement: allis clamp versus single-tooth tenaculum, a randomized control trial. Arch Gynecol Obstet. 2023 Apr;307(4):1015-1019. doi: 10.1007/s00404-022-06784-x. Epub 2022 Dec 7. |
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Physician participants were aware of assignment to utilize the single-toothed tenaculum clamp or allis clamp directly prior to IUD placement procedure. Participants were blinded to the clamp assigned.
| Single-tooth tenaculum | Procedure | Physicians utilized a single-tooth tenaculum clam for cervical stabilization during IUD placement. |
|
Number of interventions required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum.
| At the time of IUD insertion |
| Time to hemostasis | The time in seconds required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum. | At the time of IUD insertion |
| Participant reported pain | Pain reported by the participant (0-10 where a higher number indicates greater pain) at the time of IUD placement with n Allis clamp or single-tooth tenaculum. | At the time of IUD insertion |